Clinical Project Physician
Overall the Clinical Project Physician is responsible for providing medical leadership, oversight and guidance on clinical development projects under his/her responsibility from concept generation to design, implementation, execution, and submission/approval.
The Clinical Project Physician represents the medical lead for the specific assigned project in the life cycle teams.
- Provide medical leadership internally for all responsible project activities assigned (e.g. to LCT, Regulatory & Safety aspects), through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area
- Responsible for delivering the medical aspects of the Clinical Project Development Plan related to the indication and overseeing its implementation
- Actively contribute to the core medical/scientific information required in all clinical documents (e.g. Protocols, Core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high quality documents
- Contribute medical and scientific input, where appropriate, to the strategic decisions of the Life Cycle Team for assigned project(s)
- Contribute to global strategic development and provide evidence-based input to the clinical project-related, strategic and regulatory documents
- Contribute as needed to trial level medical activities
- Ensure project(s) is/are adequately supported medically and prioritized to ensure timely and on target delivery on set objectives and deliverables in line with clinical development goals
- Provide medical input to the project-related communication/publication plan
- Provide medical leadership externally based on thorough scientific review of relevant product data and consultation with internal and external experts
- Lead the development and maintenance of medical interactions with key external experts and investigators
- Organize and lead medical aspects of clinical advisory boards and study specific committees (steering committees, data monitoring committees, safety event committees).
- Contribute to clinical/scientific content for submissions to regulatory agencies and IRBs/ethics boards, answer to medical/scientific questions from Health Authorities.
- Be the company clinical expert at key regulatory interfaces, investigator meetings as well as partner meetings where applicable.
Qualifications and Experience:
- Medical Doctor degree
- At least 5 years’ experience in clinical research gained in a Pharmaceutical Company or Clinical Research Organization (CRO)
- Demonstrated experience in overseeing clinical projects from a medical perspective
- Clinical research experience in the indication of one of Client’s Therapeutic Areas (rare diseases) is of preference
- Sound knowledge of drug development based on previous deliverables
- Sound knowledge of regulatory requirements/ICH guidelines
- Good organizational, problem solving, interpersonal and communication skills
- Hands-on and results driven attitude with a good sense of urgency
- Effectively negotiates with key stakeholders to influence, convince, and gain their buy-in and agreement
- Thinks globally and understands the big picture (e.g., competitor activities, potential implications and consequences of own activities and decisions)
- Excellent written and spoken communication skills in English
- Relevant working/residency permit or Swiss/EU-Citizenship required