Clinical Development Medical Director
Jocelyn Blackham is recruiting for a Clinical Development Medical Director to join a global pharmaceutical company, heavily focused on a Breast Cancer study. This role will be based at their site based in Basel on a contract basis until September 2021. Remote working is acceptable for this position due to the current restrictions.
The main purpose of the role will be to:
- Provide clinical leadership and medical strategic input for all clinical deliverables in the assigned project, including 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.
- Lead 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)
- Oversee/conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
Further responsibilities will include:
- Interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patientadvocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
- 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.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- MD or equivalent medicaldegree required.
- Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or subspecialty) required, with Medical Board certification preferred.
- Clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- Advanced knowledge of Breast Cancer studies.
- Demonstrated ability to establish strong scientific partnership with key stakeholders.
This is an excellent opportunity tojoin a global pharmaceutical company.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 800 106 106 or email email@example.com. Please could you send any correspondence in English. Please quote reference 49695 in all correspondence.