Clinical Project Physician
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a Clinical Project Physician for a permanent position based in Basel area.
The ideal candidate should have 10 years of previous relevant experience, but still very hands on.
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