For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
Clinical Development Medical Director (m/f), 100%, Basel
The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) GPCH.
- 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
- 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)
- 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
- Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
- May be the Program Manager of other associates (e.g.., CSE).
- You would be part of a lung cancer program with ongoing Phase 2 and Phase 3 studies and possibility to work on study start-up if candidate has previous experience in study start up.
- You would work with clinical scientific experts in data review and train/mentor them in data review for assigned study(ies).
- Education: 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; CDMD will ideally have ≥3 years as a clinical research physician in the pharma/biotech industry with oncology solid tumor (lung cancer, preferred) experience.
- Clinical practice experience ≥ 4 years (including residency) preferred
- Languages: Fluent Englisch (oral and written)
- More than 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- More than 3 years of contribution to and accomplishment in all aspects of conducting
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
Start date: December 2020
End date: May 2022
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Insa Voss (+41 61 270 80 07).