Clinical Project Director

vor 4 Monaten

Basel, Schweiz Coopers Group AG Vollzeit

Clinical Development Medical Director

For our client in Basel, we are looking for a medical doctor who will be the clinical leader of program level activities.

(Duration: 12 months)

**Your responsibilities**:

- Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable.
- 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.
- May be the Program Manager of other associates (e.g.., CSE). May lead team of up to 5 reports.
- Supports the Therapeutic Area Head by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas.

**Your background**:

- MD or equivalent medical degree. Medical Board certification nice to have. Rheumatologist or someone who has experience in rheumatology as an internal medicine doctor.
- Clinical practice experience 4 years.
- 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- 3 years of contribution to and accomplishment in all aspects of conducting clinical trials in a global/matrix environment in pharmaceutical industry.
- 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.

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