Hobson Prior are recruiting for an exciting opportunity for a Clinical Development Director to join a Swiss global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives.

Job Responsibilities:

• Responsible to deliver clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable.
• As a clinical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders, internal stakeholders and internal decision boards.
• 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).
• Clinical deliverables may include clinical sections of individual protocols or substudies consistent with the Integrated Development Plans, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
• Drives 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.
• Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Experts with appropriate oversight from Medical Lead.
• 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, Drug Safety Update Reports, and other safety related documents) in collaboration with Patient Safety.
• 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.

Key Skills:

• Fluent oral and written English.
• Excellent communication skills, written and oral.
• Strong interpersonal skills.
• Excellent negotiation and conflict resolution skills.

Requirements:

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred.
• A minimum of 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 3-5 years of contribution to and accomplishment in all aspects of conducting clinical trials 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.