Clinical Development Medical Director
5 days left
- Experience Level
- Senior Management
A new vacancy has opened for a Clinical Development Medical Director to join a world-wide healthcare organisation who provides solutions to address the evolving needs of patients all over the world. This is a contract position based in Basel.
- To provide clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable.
- Accountable to lead the 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).
- You will drive execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates if applicable.
- To oversee/conduct ongoing medical and scientific reviews of clinical trial data with Clinical Scientific Experts.
- May be the Program Manager of other associates (e.g.., CSE).
- May act as study medical monitor.
- Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team, 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.
- 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.
- 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.
- Any other assigned duties.
- Excellent communication skills, written and oral.
- Robust interpersonal skills.
- Excellent negotiation and conflict resolution skills.
- MD or equivalent medical degree required.
- Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred, Clinical practice experience.
- Fluent English (oral and written).
- At least 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- At least 3 years of contribution to and accomplishment in all aspects of conducting clinical trials in a global/matrix environment in pharmaceutical industry.
- At least 4 years (including residency) preferred.
- Advanced knowledge of assigned therapeutic area.
- Demonstrated ability to establish strong scientific partnership with key stakeholders.
- In-depth knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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