We are looking for an expert in Clinical Development Program Management (Pharmaceuticals/Biotech) to join our experienced team of Consultants. We offer a permanent contract, development possibilities and cooperation with top life sciences companies in the world.
If you are a clinical development specialist, with experience in scientific & operational aspects and program & team management, do not hesitate and apply or contact us directly!
- Leads all clinical deliverables (clinical sections of individual protocols or sub-studies consistent with the Integrated Development Plans, clinical data review, program-specific standards, clinical components of regulatory documents/registration dossiers, and publications) in the assigned project or section
- Oversees/conducts an ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
- Takes responsibility for the development of clinical sections of trial and program level regulatory documents (i.e. Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Manages the teams assigned to a program, including career development, performance management and talent planning processes, on-boarding, training, & mentoring
- Supports Global Program Clinical Head in ensuring the overall safety of the molecule for the assigned section in collaboration with the Safety Management Team and Patient Safety
- Supports the Therapeutic Area Head by providing medical input into IDP and CTP reviews and contributing/driving the development of disease clinical standards for new disease areas.
- Braces interactions with external stakeholders (i.e., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards…) and internal stakeholders (i.e. Global Medical Affairs, Marketing…)
- Advanced University Degree in life sciences/healthcare (or relevant), PharmD or PhD is a plus
- Minimum of 5 years of involvement in clinical research or drug development in an academic or industry environment in clinical activities in Phases I through Phase IV
- Experience in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in the pharmaceutical industry
- Experience in oncology therapeutic area
- Ability to establish a scientific partnership with key stakeholders
- Strong background in GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process
- People management experience (for the projects, in a matrix environment and/or global)
- Excellent communication skills, written and oral
- Fluency in English