Clinical Development Medical Director- remote

Job type:
Start date:
12 months
Published at:
flag_no United Kingdom
Project ID:

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An exciting opportunity has opened for experience physician with solid clinical development experience to take on a project in oncology ph II-III.
Major Activities:
1) Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
7) Supports (Sr.) in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
8) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
9) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
12) Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
MD / Physician
Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred;
Strong experience in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV
clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
Advanced knowledge of assigned therapeutic area
Demonstrated ability to establish strong scientific partnership with key stakeholders
Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
Excellent communication skills, written and oral
Strong interpersonal skills
Excellent negotiation and conflict resolution skills

The role can be offered on home-based basis.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.