Clinical Development Director
Jocelyn Blackham is recruiting for a Clinical Development Director to join a leading pharmaceutical company at their site based in Basel on a contract basis for 6 months.
The Clinical Development Director is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), and/or indication related clinical trial(s).
They will be responsible for:
- Providing clinical leadership and 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 or sub-studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
- Leading 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).
- Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead.
- Supporting relevant members of the team, 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.
Further responsibilities will include:
- Supporting the 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.
- Serving on or leading global initiatives (e.g. process improvement, training, SOP development, other Clinical Development line function initiatives).
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred.
- Previous involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
- 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.
- Oncology Data Review is desirable (Submission Activities would be a plus).
This is an excellent opportunity to join a leading pharmaceutical organisation.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email email@example.com. Please could you send any correspondence in English. Please quote reference 47396 in all correspondence.