SomervilleRecruiter Since 2001
the smart solution for Somerville jobs

Medical Director, Clinical Development, Immunology

Company: Biogen Idec
Location: Somerville
Posted on: January 12, 2021

Job Description:

Job DescriptionThe position of Medical Director, Clinical Development sits in the Immunology emerging therapeutic area --- a component of the Clinical Development Organization. The new Medical Director will support one or more development programs involving products in Lupus or other autoimmune disease. They will work in close collaboration with the Medical Director and cross-functional clinical study teams and provide clinical science support for assigned programs in immunology. The initial focus will be in leading designing clinical development protocol and clinical trial in late development. Activities include direct responsibility for advancing high priority clinical programs through clinical study design, protocol development and study conduct.The Medical Director has the following responsibilities: Will report to a more senior member of the immunology-rheumatology clinical team who has direct responsibility for the overall research strategy and clinical and scientific development activities.Will lead conceptualization and development of clinical trials in conjunction with multiple functions, including development from inception of trials in new indications.Drive development of clinical development plans and protocols for clinical studies; May serve on one or more study management teams as a clinical development functional area leader, participating in all aspects of trial execution as required, including presenting at clinical study investigator meetings, monitoring and reviewing incoming safety &efficacy data, engaging with study physicians, reviewing final data outputs and other activities as needed.Provide ongoing medical expertise and medical oversight of clinical trials, including eligibility evaluation and toxicity management, in conjunction with external and internal partners.Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, IND, briefing books);Provide clinical scientific input to business development (e.g. due diligence);Provide medical leadership for programs that integrate the individual---s knowledge in in basic science, drug development, and medical practice with input from the medical community around the world.Develop and deliver presentations to internal and external stakeholders.Elaborate and integrate the scientific and clinical rationales, regulatory requirements to support buidling a solid Clinical Development Plan (CDP), including appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP.Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice.May interface with key medical experts and represent the team at medical congresses and conferences.LI-NM1QualificationsBiogen is excited to expand the immunology space and add depth to their Clinical Development Team. The ideal candidate will have the following mix of professional and personal characteristics:MD/MD-PhD with Immunology-Rheumatology training, ideally with a clinical background in Lupus.Five (5) years of experience including clinical research in academia and progressive responsibilities in drug development in industry (clinical trial experience mandatory). Industry experience in immunology, specifically Lupus strongly preferred.Capacity and willingness to work effectively across disease areas.Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment.Ability to compile and present development plans, study designs, analyses of data in forums consisting of individuals representing a variety of functions (eg, both with and without scientific backgrounds).Excellent communication skills (oral and written) and excellent organizational skills.The ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. Must be able to work with minimal supervision.Ability to represent the department on project teams, committees and at external meetings.Able to work collaboratively in a multi-disciplinary team setting and employ a team approach to decision-making.Ability to balance multiple competing demands and meet aggressive timelines.Scrupulous attention to detail, clear ability to think critically, establish and maintain rapid timelines, and persistent commitment to ensuring a high level of quality.Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (20%-30% potential travel, within current COVID-19 regulation).Additional InformationThe position of Medical Director Clinical Development sits in the Immunology emerging therapeutic area --- a component of the Clinical Development Organization. The new Medical Director will support one or more development programs involving products in Lupus or other autoimmune disease. They will work in close collaboration with the Medical Director and cross-functional clinical study teams and provide clinical science support for assigned programs in immunology. The initial focus will be in leading designing clinical development protocol and clinical trial in late development. Activities include direct responsibility for advancing high priority clinical programs through clinical study design, protocol development and study conduct.Location is flexible to Cambridge MA, Maidenhead UK, or Baar Switzerland.SummaryType: Full-timeFunction: Other

Keywords: Biogen Idec, Somerville , Medical Director, Clinical Development, Immunology, Executive , Somerville, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Senior Product Marketing Manager
Description: Everbridge is looking for an action-oriented, results-driven Senior Manager of Product Marketing to develop and execute the brands product positioning and messaging. You will be the mastermind behind (more...)
Company: EverBridge
Location: Burlington
Posted on: 01/21/2021

DIRECTOR, RESIDENCE HALL, Division of Student Life, Residence Life
Description: DIRECTOR, RESIDENCE HALL, Division of Student Life, Residence Life Tracking Code7507 Job Description The employees of Residence Life at Boston University are dedicated to enhancing a student---s academic (more...)
Company: Boston University
Location: Boston
Posted on: 01/21/2021

District Manager, Oncology Breast - Northeast
Description: Job DescriptionJoin a Legacy of Innovation 110 Years and CountingWith over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the (more...)
Company: Daiichi Sankyo
Location: Boston
Posted on: 01/21/2021


Director, End User Technology Support
Description: Director, End User Technology Support - 2003529 Santander is seeking a seasoned leader to bring and drive new ideas and help to build a new foundation for End User Technology Services. Incumbent must (more...)
Company: Santander Holdings USA Inc
Location: Rockland
Posted on: 01/21/2021

Director GMP Quality - Cell & Gene Therapy
Description: In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Temporary Materials Management Associate
Description: This role involves managing materials in support of continuous drug product br br manufacturing, clinical manufacturing, kilo lab, and analytical laboratory operations that span development and commercial (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Clinical Development Associate Medical Director
Description: The Associate Medical Director will serve as the Medical Lead for Vertex clinical trials in CF, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Commercial Operations Associate Director, Field Optimization
Description: The Associate Director AD of Field Optimization reports to the Senior Director of Commercial Data Management Field Optimization in the US Commercial organization. This individual serves as the Lead (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Associate Director, Strategic Sourcing
Description: As the Associate Director of Strategic Sourcing for Cell and Gene Therapy, you will be a part of a fast-growing and innovative organization at the company's world headquarters in Boston, MA. The Department (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Director, West Region State Government Affairs & Public Policy
Description: Director State Government Affairs Public Policy will be responsible for developing and implementing the company's state/regional government affairs and public policy strategy. This position will work (more...)
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: 01/21/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Somerville RSS job feeds