Manager, Regulatory Submission Management
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability. Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management. Duties and Responsibilities: Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines. Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management. Identify issues that may delay product or project and recommend appropriate action. Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology. Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity. Prepare and maintain templates that meet Regulatory electronic submission standards. Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams. Qualifications: Basic qualifications: Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required. Preferred qualifications: Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired. Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired. Want to learn more about us? ... Read more »
Sr. Manager, Regulatory Submission Management
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: The Sr. Manager will be an integral member of the Global Regulatory Dossier Management Group. The Submission Manager will have overall responsibility for management of complex regulatory submissions, leading cross-functional submission teams for new drug applications (NDAs and MAAs) and investigational applications (INDs and CTAs). On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines, managing the cross-functional submission review process and reviewing submission content for completeness and adherence to regulations and regulatory guidance. Duties and Responsibilities: As leader of cross-functional submission teams, plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines. Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management. Prepare and maintain templates that meet Regulatory electronic submission standards. Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams. Qualifications: Basic qualifications: Minimum of 7 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability. Preferred qualifications: Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired; experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired. Science degree or background strongly desired. Want to learn more about us? ... Read more »
Medical Science Liaison - Gulf
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as extensions of the Global Medical Affairs organization. MSLs facilitate data development and dissemination through interactions with internal & external investigators; support educational development of colleagues, opinion leaders, & customers through appropriate & fair-balanced scientific exchange; and provide clinical/scientific support for Millennium Pharmaceuticals and Medical Affairs department initiatives at the direction of Medical Affairs management. The Gulf Territory includes, in part: Texas, Louisiana, Mississippi, Alabama, and Georgia. Duties and Responsibilities: Facilitate research interactions between Millennium and external investigators (including liaison between Clinical Operations & study sites, and proposal through publication facilitation of Investigator-Initiated studies). Cultivate & maintain relationships between Millennium and external opinion leaders through appropriate scientific exchange. Enhance clinical/scientific knowledge of customers and colleagues through education and appropriate scientific exchange [responding to unsolicited requests for medical information, development & delivery of educational materials, presentation of scientific data at promotional (on-label) and non-promotional events]. Support appropriate cross-organizational initiatives as determined by Global Medical Affairs management. This position involves travel of more than 50%. Qualifications: Basic qualifications: Advanced degree in clinical/life science discipline and 2+ years pharmaceutical industry experience (R&D, Medical or Scientific Affairs). Strong interpersonal skills, teaching/presentation skills, and analytical ability. Preferred qualifications: Terminal degree in a clinical/scientific discipline (MD, PhD, or PharmD) with a publication track record. Clinical or laboratory experience in an Oncology-related setting and/or 2+ years oncology MSL experience. Working knowledge of Regulatory/Compliance guidance (including OIG & PhRMA Code) relevant to industry interactions with customers. Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: As Clinical Scientist, support the development of one or more oncology programs from pre-phase 1 through phase 3 and global registration. Duties and Responsibilities: Responsible for working collaboratively with the medical lead and team to execute the clinical program(s). Specific role will include some or all of the following responsibilities: Assist in planning, executing and reporting global clinical trials Conduct medical review of adverse events Assist in interpretation of efficacy and safety data from clinical trials Assist in ensuring regulatory compliance for clinical trials and reporting Assist in writing and designing standard protocols and amendments Assist in developing publications, abstracts, presentations, and/or clinical sections of regulatory documents. Qualifications: Basic qualifications: RN/Pharm.D. or equivalent (BA/BS/Ph.D. may be considered if the candidate has substantial oncology clinical research experience) 2-3 years oncology clinical research experience in an academic or in an industry setting Preferred qualifications: Proven scientific writing skills, with strong inter-personal, written/verbal communication skills Want to learn more about us? ... Read more »
Sr. Manager/Associate Director, Labeling & Promotional Compliance
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: Millennium is seeking a Sr. Manager/Associate Director, Labeling and Promotional Compliance, to assist in the management of all aspects of the labeling and the promotion of medical products. The incumbent will play in important role in the operational oversight of all promotional materials, labeling, art, film, and plate proofs to meet all medical, legal, and regulatory requirements, and will help ensure awareness of evolving US regulatory initiatives that apply to labeling and promotional compliance. This position reports to the Director, Labeling and Promotional Compliance, based in the US headquarters. Duties and Responsibilities: Under the leadership of the Director of Labeling and Promotional Compliance, manages key aspects of Labeling and Promotional Compliance operations in the United States, including: Reviews and determines labeling needs for specific products. Reviews labeling and promotional compliance processes and procedures. Develops and implements new methods to improve the efficiency of the Labeling and Promotional Compliance Department. May serve as liaison to government agencies on promotional compliance issues. Interfaces with Medical Affairs and Legal Departments, as well as Alliance Partners to resolve labeling and promotional compliance issues. Qualifications: Basic qualifications: A minimum of 4 years of experience in regulatory promotional compliance and product labeling in the pharmaceutical industry. Preferred qualifications: Strong knowledge of US regulatory labeling and promotional compliance requirements. Working knowledge of global regulatory requirements. Strong knowledge of clinical medicine and/or clinical pharmacology with a good understanding of medical concepts and terminology. Strong understanding of drug indications. Able to work across different therapeutic areas and different stages of clinical development. Strong communication skills. Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Master's degree preferred. Want to learn more about us? ... Read more »
Senior Scientist, Molecular Medicine Imaging
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: This role as the Imaging Lead Scientist will be either a Senior Scientist II or an Associate Director depending on experience. This role will be a senior level individual contributor acting as the key liaison in the Molecular Medicine group. Working with other senior leaders in highly matrixed project teams, the primary responsibility will be to manage the transition of various imaging programs from late stage R&D to Phase I/II clinical trials. Duties and Responsibilities: . Design image acquisition procedures and study protocols for early oncology clinical studies . Design and implement image analysis and interpretation procedures for quantitative assessment of imaging data . Develop exploratory early clinical trials to evaluate novel imaging biomarkers through local alliance with leading clinical imaging sites . Develop imaging charters and eCRFs for functional imaging biomarkers . Work closely with clinical sites to ensure acquisition of high quality imaging data . Design and consult on creation, transfer and maintenance of clinical trial imaging data within the oncology organization . Work closely with academic investigators, imaging CROs and key groups within organization to ensure timely and high quality clinical study acquisition and analysis of imaging data . Work closely with research scientists within organization and with academic/commercial collaborators to ensure efficient translation of novel non-clinical imaging approaches to be used in clinical studies . Provide support and oversight of late stage clinical studies incorporating anatomical imaging Qualifications: . PhD with at least 8 years academic and/or pharmaceutical company experience in functional imaging technologies. . Experience in applying imaging technologies to early and late phase clinical trials. . Knowledge of oncology therapeutic area. Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: We are seeking a highly motivated and experienced individual to join the Department of Molecular and Cellular Oncology at Millennium Pharmaceuticals to support the advancement of our oncology drug discovery pipeline. The ideal candidate will have a basic knowledge of cancer biology and diverse experience in molecular and cellular biology techniques. Duties and Responsibilities: The successful candidate will be expected to evaluate drug candidates in in vitro cell culture systems, including spheroid/3D cell cultures, by light, timelapse and immunofluorescence microscopy, cell viability assessments, and analysis of cell signaling pathway markers. This position involves working on multiple projects and participating in cross-functional teams. Qualifications: Basic Qualifications: Candidates must have a B.S. or M.S. in a biological science and 2+ years of postgraduate experience in cellular biology with extensive skills in mammalian cell culture. Candidates must also be proficient in a wide range of molecular and cellular biology techniques including: microscopy, cell transfection, generation of stable cell lines, RNAi and western blotting. Preferred Qualifications: Experience with 3D cell culture is highly desirable. Excellent analytical, organizational, communication and collaborative skills are essential. Want to learn more about us? ... Read more »
Associate Director, CMC Regulatory
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: This individual is expected to provide leadership within Regulatory Affairs and will be responsible for actively contributing to the development and implementation of CMC regulatory strategy for large molecule products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with FDA. Duties and Responsibilities: Develop global CMC regulatory strategy for development products. Direct management of assigned large molecule development programs. Drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents). Represent Regulatory Affairs at various project team and working group meetings. Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines. Expected to develop and manage project timelines as well as have the ability to multi-task. Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic. Contribute to the development of equivalency protocols, validation protocols, and stability protocols. Ensure the quality and content of all submissions to health authorities. Liaise with partnering companies to ensure regulatory alliance. Act as direct point of contact with FDA and other regulatory authorities for CMC related issues. Mentor and coach junior regulatory staff and other team members. Qualifications: Basic Qualifications: Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 6-8 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry. Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required. Preferred Qualifications: Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral). Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: Plans and manages clinical operations for assigned clinical project(s) including timelines, budgets, personnel resources, investigational sites, vendors and key project deliverables; manages, mentors and provides professional development guidance to assigned clinical operations staff members. Duties and Responsibilities: Provides strategic planning expertise, drafts the operations components, and ensures operational feasibility of clinical development plans and scenarios, including budget and resource estimates Manages the preparation of clinical sections of IND submissions, IND annual reports, investigator brochure updates, BLA/NDA submissions, NDA annual updates and clinical study reports Convenes and leads cross-functional clinical teams Coordinates and drives completion of the protocol concept, final protocol and template informed consent form Develops outsourcing specifications for vendor requests for proposal and scope of work agreements; participates in and guides study team in vendor selection and management throughout the life of assigned clinical project(s) Works with study team(s) to determine patient recruitment strategies and operational feasibility and implementation of study objectives Authors and refines Clinical Operations Plans and study monitoring plans Leads ongoing study team review of data Manages and communicates to senior management overall clinical strategic operations plan for projects including timelines, internal and external resources/costs, key deliverables and key data issues Plans, convenes, runs and presents at investigator meetings Drafts study site agreements and budgets Develops and manages study timelines Identifies and provides solutions and direction related to key cross-functional, sponsor-site, and sponsor-CRO clinical trial issues Qualifications: Basic qualifications: BA/BS/RN/RPh (preferably in healthcare/science field) with 5+ years of progressive experience in clinical operations including site management and site monitoring Preferred qualifications: Thorough understanding of FDA, ICH, and GCP guidelines as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs Ability to lead a cross-functional team in a matrix environment Excellent interpersonal and negotiation skills Strong verbal and written communications and presentation skills Proven problem solving and decision making skills Strong leadership, planning and project management skills Ability and willingness to travel 25% of the time (international and domestic) Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: As the primary liaison between Millennium and the investigator, performs on-site monitoring visits and associated planning and follow-up activities; works with the Manager, Clinical Operations, Clinical Research Manager and other members of the clinical project team in the planning and execution of clinical trials. Duties and Responsibilities: Participates as a member of the Clinical Trial Working Group to meet clinical trial goals Travels to and monitors clinical trial sites to ensure: The trial is conducted in compliance with the protocol, Good Clinical Practices, and Standard Operating Procedures Reported trial data are complete, accurate, and verifiable with source documents The rights and well-being of trial subjects are protected Clinical trial material is stored, accounted for, and disposed of appropriately Investigator study files are up to date and complete Subject enrollment efforts are on track Appropriate site personnel resources are devoted to the trial Serves as the primary point of contact for investigator site questions Manages site data collection and cleaning activities Reviews investigator site contracts Reviews site-specific Informed Consent Forms Writes and submits reports of investigational site findings (e.g., TCRs and trip reports) Supplemental activities: May also be involved in the development of the study protocol, case report form, procedure manuals and the study report as well as in the organization of and/or participation in study investigator meetings. Qualifications: Basic qualifications: BS degree with 4+ years or MS with 2+ years of relevant experience including 1+ year(s) of independent monitoring; the ideal candidate will have monitoring experience in all clinical trial phases as well as a clinical background. Preferred qualifications: Strong knowledge of clinical regulatory requirements (i.e., FDA, GCP and ICH) Detail orientation Ability to multi-task Strong interpersonal and written and verbal communications skills Problem solving skills Ability and willingness to travel 35% to 40% (domestic and international) Willingness to work in different therapeutic areas Proficiency in MS Office applications Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: This Associate Director position is established to play a key role in the planning and management of regulatory submissions to global health authorities. This individual is expected to provide leadership within Regulatory Affairs and all other data-generating departments to ensure timely filing and approval of assigned oncology programs. Duties and Responsibilities: Direct management of assigned oncology programs; driving all submission activities (IND/CTA, trial maintenance, NDA/BLA) and health authority interactions (meeting requests and briefing documents); represent Regulatory Affairs at various project team and working group meetings; assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines; contribute significantly to the development of regulatory strategy plans; liaise with partnering companies to ensure regulatory alliance; act as direct point of contact with FDA and other regulatory authorities for general issues; mentor and coach junior regulatory staff and other team members. Qualifications: BASIC QUALIFICATIONS: A BS degree in a scientific or technical discipline plus a minimum of 6-8 years experience in Regulatory Affairs is required. Previous experience in leading submission teams for marketing application and/or clinical trial applications is also required. Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements. Direct experience in interacting with regulatory authorities; Candidates must be able to influence others and demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral). PREFERRED QUALIFICATIONS: Knowledge of EU, Canada, ROW and post-marketing and experience interacting with DDMAC is a plus. Advanced degree preferred. Want to learn more about us? ... Read more »
Director, Regulatory Labeling & Promotional Compliance
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: This individual is expected to provide leadership within the Regulatory Affairs Labeling and Promotional Compliance group and will be responsible for actively contributing to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This person will serve as the Regulatory Labeling representative on relevant project teams, and as a Regulatory contact with DDMAC for assigned products. Duties and Responsibilities: Directs the regulatory labeling activities of programs and professionals Chairs the Labeling Working Group Represents Regulatory on the Promotional Material Review Team (PMRT) and is accountable for ensuring that all promotional materials and activities are compliant with promotional/advertising regulations and healthcare authority guidances. Accountable for development and execution of global regulatory labeling strategies Ensures adequate communication with Therapeutics, CMC and International and Operations Regulatory functions Ensures alignment of overall key labeling statements and key messages across labeling documents Accountable for the timely preparation and content of core data sheets and labeling documents Responsible for leading interactions with DDMAC for assigned products Is accountable as required for escalating issues to upper management, evaluating regulatory risks and developing mitigations plans for promotional materials and labeling in close cooperation with regulatory senior management Provides advice and counsel on labeling impact/requirements during discussions of labeling concepts during early stage product development. May propose draft labeling text during these discussions. Communicates changes in regulations and practices to the organization effectively and quickly. Qualifications: Basic qualifications: A minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful. Must have a minimum of 10 years experience in Regulatory Affairs Labeling or Promotional Review or equivalent experience within the pharmaceutical industry. Preferred qualifications: Previous experience in participating in early stage development discussions including Target Product Profile and determination of relevant clinical endpoints to inform the proposed product label is also preferred. Demonstrate a solid working knowledge of drug development process and knowledge of FDA labeling and promotional requirements; EU, Canada, and ROW experience highly desirable. Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral). Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: We are seeking a research scientist with experience in drug development (preferably oncology) to join the Molecular Medicine Department. This person will be responsible for identifying and implementing clinical biomarker programs for one or more of our investigational anticancer drug programs. This senior level individual contributor role will direct the translation of preclinical research into clinical applications. Duties and Responsibilities: The successful applicant's responsibilities will include: a) oversee the development and monitor the quality assurance of pharmacodynamic, pharmacogenomic and disease biomarker assays for use in company-sponsored clinical trials, b) oversee the design and implementation of biomarker research in clinical trials, c) work with medical directors, clinical pharmacologists and nonclinical and discovery research scientists to ensure early definition of, and agreement on biomarker needs for clinical development strategy and d) maintain extensive knowledge of the research and development efforts from academic institutions, competitor pharmaceutical companies, and fee-for-service bioanalytical companies for relevant oncology biomarkers. Qualifications: Basic Qualifications: Doctoral degree (PhD.) and 10+ years of industry experience in molecular medicine. Specific experience in application of biomarkers and translational medicine strategies during oncology drug development. Preferred Qualifications: Broad understanding of biomarker applicability in early and late stage oncology drug development. A strong background in cancer biology with experience in biomarker identification and validation (including the use of imaging), and developing diagnostic strategies. Understanding of the necessity for close collaboration with Discovery, clinical, clinical pharmacology and statistics. Experience with academic research collaborations, contract laboratories, budget, preclinical study designs, and early drug development (phase 1 and 2) are also beneficial. Demonstrated technical, administrative, and project management capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the corporation. Scientific Excellence: demonstrated understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development. Demonstrated scientific productivity (e.g. publications, research reports, etc). Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: Provide leadership within a specific Global Medical Affairs function and actively participate/lead in broad range of medical affairs activities, including: - Preparation of clinical development plans - Design and conduct Phase IIIB/IV trials - Medical leadership in materials review Global Medical Affairs reports to both Development and Commercial, therefore, the Medical Affairs physician plays a key role in Development activities and provides input to product development teams regarding optimization of Commercial aspects of development as well as to Commercial teams regarding the data generated from clinical trials. This physician will represent Global Medical Affairs on product teams (starting at proof of concept) and must represent all Medical Affairs functions, lead a GMA subteam to support the product team, help to develop the value proposition, define appropriate publication support, be concerned with safety oversight, KOL interactions and advisory board planning. Duties and Responsibilities: This position has potential for advancement within Medical Affairs. A qualified candidate with the right experience can assume increasing levels of responsibilities, including leading specific functions within Medical Affairs and people management. Qualified candidate will be an integral part of the leadership team in determining strategy, annual goals and maintenance of excellence in standards and practices. Specific accountabilities include: - Participate in the development and review of investigator initiated studies - Presentation of data at regional and national advisory boards - Conducting site visits and hospital lectures - Coach and teach the Sales Force and Medical Science Liaisons - Regular interation with key medical opinion leaders Qualifications: Basic Qualifications: Board certified/board eligible MD with a minimum of 5 years in a clinical or pharmaceutical setting with background in Medical Affairs and/or Clinical Research. Must have extensive experience in hematology and oncology. Requires experience and success in working in a matrixed, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results. Excellent interpersonal skills, a very strong sense of collaboration, as well as strong communication and presentation skills (both written and verbal) are required. Ability to work successfully in a fast paced environment which requires high energy, vision, innovative thinking, flexibility and resilience. Must understand and respect Millennium's core values and possess the highest integrity. Broad working knowledge of GCP/ICH/FDA requirements, clinical trial design and strategies, commercial and publication strategy and medical information process. Willingness and availability to travel. Millennium is a global company and this is a critical aspect of activities for physicians. Additional Qualifications: In-depth experience in both clinical development and traditional medical affairs activities is preferred. Want to learn more about us? ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: Supports Global Pharmacovigilance with an emphasis on a selected investigational or marketed product Duties and Responsibilities: . Support Global Pharmacovigilance . Serve as a resource for the Medical Information and Quality Control teams . Serve as named clinical safety medical advisor for selected drug development programs . Assist and support the activities of the Vice President, Pharmacovigilance . Communicate effectively in safety matters with Regulatory Affairs, Clinical Teams, Statistics, Data Management, Marketing, and the Legal Department . Provide advice regarding investigations of special questions regarding safety of investigational and marketed products . Handle adverse events according to national and international regulatory requirements . Ensure adequacy of recording, summarizing, and handling of adverse events for marketed products including decisions on seriousness and expectedness . Ensure accuracy and timeliness of expedited and periodic reports from postmarketing safety surveillance . Ensure accurate coding of adverse events . Ensure due diligence in characterizing adverse events . Implement formal signaling procedures . Characterize expected rates of key adverse events in target populations . Participate in product labeling decisions . Provide expert advice on medical matters in general, and specifically on safety-related issues concerning investigational compounds, marketed products, and postmarketing trials . Ensure effective communication in safety matters with Clinical Research, Nonclinical Research groups, Project Management, Regulatory Affairs, and Marketing Strategic Planning to ensure effective interactions and exchange of all relevant information . Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products . Collaborate with consultants concerning drug safety issues and pharmacoepidemiology studies . Ensure adequacy of recording, summarizing, and handling of serious adverse events from clinical trials including decisions on seriousness, expectedness, and causality . Ensure accuracy and timeliness of expedited and periodic reports from clinical trials . Review safety sections of clinical trial protocols, investigator brochures, and informed consents for selected drug development programs . Provide strategic input to and in certain instances lead safety analyses including but not limited to investigator letters, periodic reports on marketed and investigational products, clinical trial protocols, investigator brochures, and Integrated Summaries of Safety . Work with Clinical Teams and Project Management and interface with CRO Safety . Perform such other duties as requested by management Qualifications: Required . M.D. degree or equivalent . At least 2 years in pharmaceutical medical research with at least 1 of those years spent in product safety/pharmacovigilance/benefit-risk optimization . MedDRA training . GCP training Desired . Graduate training/experience resulting in board eligibility/certification . Postgraduate training in clinical epidemiology and biostatistics . Specialization and experience in gastroenterology/hepatology, nephrology, hematology, dermatology, neurology, intensive care, oncology, inflammation, or clinical pharmacology Want to learn more about us? ... Read more »
Southwest Regional Director, Medical Science Liaisons
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: As the Southwest Regional Director, you will assist in the management of the Oncology Medical Science Liaison group. You will help set the vision and the tone for the operation of the group and, working with the Medical Affairs management team, help execute the ongoing MSL strategy. You will have oversight of key MSL programs such as management of Key Opinion Leaders (KOL's), submission and pull-through on Independent Investigator Initiated Studies (IIS's) and assisting with key investigators on Millennium-sponsored research initiatives. Duties and Responsibilities: You will assist with ongoing development of the MSL program in critical areas such as training and development of MSL's, ensuring proper MSL focus and resourcing and assuring adequate and appropriate attendance at medical meetings. You will serve as an interface between the MSL's and other internal departments (Sales, Marketing, Clinical Operations, etc.) when necessary. You will ensure legal and regulatory compliance for all MSL activities. As a regional manager you will also provide supervision for the MSL's assigned to you, in alignment with the other Regional Directors. This will include coaching and mentoring, hiring and training of new MSL's, performance management, and professional development. You will be responsible for expense reporting, budget management and forecasting. In addition to regional people management and collaborative national team management, you may also be responsible ( ... Read more »
2010-08-31 10:20:55
Company Information: Breakthrough Careers! A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality. Position Summary: Manages all aspects of an assigned clinical program(s) (globally) to ensure that all studies within the program are completed on time within budget and in compliance with SOPs, Regulatory regulations and ICH/GCP guidelines and in alignment with Therapeutic Area (TA) strategies and goals. Duties and Responsibilities: Working with the MD, the Clinical Program Manager provides input to the development of the Clinical Development Plan (CDP). Uses knowledge of therapeutic area and TA strategies and operational expertise to oversee the Clinical Sub-team for assigned molecules, takes a leadership role in the implementation/ execution of the CDP, and participates in the development of clinical trial protocol concept in collaboration with the sub-team. Utilizes operational expertise, knowledge of TA strategy and TA scientific input when planning program feasibility, developing strategies for country selections, CRO/ vendor use and evaluations and planning for contingencies. May participate in business development evaluations from the clinical research and operational perspective as applicable. In conjunction with the sub-team, contributes to creation, implementation and revision of the CDP; evaluates and ensures that CDP is feasible, (i.e., that the key clinical development milestones are achievable within the constraints of the available human resources and the proposed budget and timelines) and oversees implementation of CDP into study protocols. Establishes and cultivates relationships with site investigators and Key Opinion Leaders, ensuring up-to-date knowledge of current clinical research landscape and operational feasibility in relevant indications and locations. In conjunction with the sub-team, coordinates all relevant Clinical Development activities/documents related to Regulatory Submissions (e.g., IB, IND, Annual Reports, BLA, NDA or other regulatory filings). Provides input into creation of program budget. Ensures Clinical Development portion of program is conducted within budget and identifies, escalates and/or resolves discrepancies. Tracks and oversees all studies related to the program's CDP(s). Ensures consistency within all program studies, alignment to overall time lines and budgets, TA strategies and corporate objectives. Provides mentoring, leadership and guidance to clinical trial management staff as well as direction and oversight on protocol development, associated clinical documents (e.g., CRFs, charters, etc.) and study execution, including ensuring that GCP principles are followed. Participates in recruitment, development, and training of trial management staff. May have direct line management of program-related Clinical Trial staff. Oversees the Clinical Trial Working Group (CTWG) strategy for site and vendor selection, and approves final investigator site and vendor selection for clinical trials at the program-level. Ensures consistency and GCP compliance within all program clinical trials, and ensures alignment with the therapeutic area and commercial strategy. Qualifications: Basic Qualifications: Must have experience in relevant therapeutic area. Bachelor's degree science required; must have excellent current knowledge of clinical research; must have proven excellence in cross-functional matrix or direct line management of clinical trial personnel. Preferred Qualifications: Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development; Excellent project management skills, including risk assessment and contingency planning. Also requires excellent leadership, communication, management and organizational skills, along with problem solving, conflict resolution, and team building skills. Education typically requires 8 years of global drug development with experience managing clinical projects within time, budget, and quality expectations; AdvWant to learn more about us? ... Read more »
Co-Manager, LOFT, Wayside Commons
2010-08-31 10:20:55
** IF YOU ARE INTERESTED IN THIS POSITION, PLEASE CONTACT THE STORE DIRECTLY AT AND ASK TO SPEAK WITH A MANAGER TO INQUIRE ABOUT THIS OPPORTUNITY! THANK YOU! Position Overview: In partnership with the Store Manager, direct all activities required to achieve all store goals, including sales objectives, client service, human resource management, payroll and operating expenses, loss prevention, and merchandise presentation while driving both associate and client engagement. Primary Responsibilities/Accountabilities: Directs client service efforts that are consistent with Ann Taylor standards, to increase transactions and capture client opportunities Assists with development of team to accomplish store’s business objectives through recruitment, selection, coaching, investment, engagement, retention, and motivation Supports attainment of sales, payroll, and inventory shortage goals Execution of merchandise presentation, restocking, and recovery to maximize productivity Understands the Ann Taylor culture and ensures compliance with all Ann Taylor Values & Practices, and store operational standards Additional responsibilities as assigned by Store Manager, District Manager, or Regional Vice President Revenue Generation: Understands how to maximize daily business Drives toward store’s achievement of quantifiable performances (e.g. Net Sales, ROV, Conversion, UPT, DPT, payroll, inventory shortage, Operational Assessments, and credit cards) Studies business reports to gain understanding of inventory problems and/or areas of opportunity People Management: Fosters a client-focused team environment by driving volume and anticipating clients' needs Provides exceptional client service by role modeling the Ann Taylor service standards Takes responsibility to immediately addresses client concerns Communicates appropriate goals, results (e.g. financial performance and productivity), and directives Actively manages associates’ client service skills by providing informal and formal feedback Assists in the recruitment, selection, and hiring of diverse talent Holds self and associates accountable for achievement of financial results and statistical standards Constructively confronts and provides feedback to help resolve conflict Seeks a continuous learning environment by requesting input and involving others Treats others fairly and with respect, valuing differences; builds relationships based on an individualized approach Assists in the development of associates by delegating appropriately and matching talents with tasks, while recognizing accomplishments Supports Store Manager and fosters team commitment through building relationships and recognizing individual contributions Forms networking relationships with internal and external peers Store Operations: Prioritizes and executes daily and weekly tasks (e.g. Price Changes, MOS, Special Orders, merchandising needs, payroll adjustments, processing of shipment, transfers, and proper claims process) Supports Loss Prevention practices and completes operational assessments to protect company assets Maintains the store’s organization, appearance, and cleanliness Uses available resources to assist in executing tasks/directives Ensures safe work environment, including OSHA compliance Product / Brand Management: Executes visual merchandising updates and product placement within corporate guidelines and maintains visual standards as defined by the Visual Merchandising Guide Uses product knowledge tools to execute directives and interpret Store Sets Executes company brand initiatives to the physical store layout Supports continuous product movement based on company directives, client profile, and store sales Integrates strategic activity on the floor, which includes restocking and recovery Clearly articulates the company's brand positioning Educates associates on marketing initiatives, product placement, lifestyle concepts, and product knowledge Models Ann Taylor’s Values & Practices while holding associates responsible for their actions Applies knowledge of product with internal and external clients Understands Ann Taylor’s competitors and communicates competitive landscape Position Requirements: Human Resources: Proven ability t ... Read more »
North American Sales Manager--Consumer Products
2010-08-31 10:20:55
Must have experience in Consumer Products Goods with emphasis on Genral Merchandise categories. Experience with or exposure to national accounts such as Walmart, Target, K-Mart, Home Depot, Lowe's Best Buy, Walgreen's, Staples, Office Depot, OfficeMax, etc. Essential Job Functions: --Responsible for all sales activities and personnel involved in Sales for the Consumer Products Strategic Business Unit --Has revenue responsibility for all products and services for the Consumer Division --Plans, builds and executes business plans which drive top line revenue growth across all customers while delivering profitability --Actively leads, participates, and manges pipeline and bookings/sales forecasts --Develops, institutes ansd manages performance maps to set expectations and drive achievement --Leads and coaches personal development; manages a remote team --Work collaboratively with marketing, customer service, other divisions and sister companies to drive initiatives --Develops and/or maintains and improves business relations with all customers of the Consumer Products Division --Seeks out and targets new customers and new sales opportunities, initiates action plan to approach and secures new business for the division --Involved in the contract review process to assist with the approval of account vendor agreements, documents and amendments --Travel to customer sites, trade shows, etc. Overnight travel required. Ability to drive. --Direct Account responsibility ... Read more »
2010-08-31 10:20:55
Adecco is seeking an experienced Project Manager for a 4 month contract position within a premier financial services company located in Quincy, MA. Will provide overall strategic leadership in program governance Independently analyze, research and resolve issues Collaborate with project managers to insure solutions are implemented quickly Use a broad array of communication vehicles to lead and direct others towards a common goal Establish rapport with the internal business partner to learn their business in order to support their needs and requirements Accountable for making decisions aligned with company goals Ability to see all available options and can arrive at a decision in line with organizational goals Understand the definition and impact of business and legal terms Requirements: Experience in project management and procurement Understanding of product life cycles Experience with SOW review to identify legal terms Coordinate with managers and vendors to process SOWs Responsible for 200+ SOWs per year Manage the work through the signature process Must have an advanced knowledge and use of technology to support the business requirements Understanding of IT projects and their component parts Ability to establish metrics and reporting for continuous improvement Relationship management with: PMO staff, IT Management, GPS Management, Vendor Management Assist in the development of RFPs with contracted suppliers Local candidates only, please. To be considered for this opportunity, please fill out our online application at adeccousa.com or call Laura Sullivan at 617-951-2560. The Adecco Group is a Fortune Global 500 company and the global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Adecco Group offers benefits including Holiday, 401(k), Insurance Benefit Plans and Service/Anniversary Bonus opportunities. Adecco Group is an Equal Opportunity Employer. Visit www.adeccousa.com to learn more. ... Read more »