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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 for a Clinical Project Physician for a 12 month contract role based in the Basel area. The CPP 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 represent the medical lead for the specific assigned project in the life cycle teams. Provide medical leadership internally for all TA-responsible project activities (e.g. to LCT, Clinical Team, Regulatory & Safety aspects), through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area

Clinical Project Physician(5109 LBD) 

Main Responsibilities:

  • Provide medical and scientific input, as appropriate, to the strategic decisions of the Life Cycle Team for the assigned project(s)
  • Contribute to global strategic development and provide evidence-based input to the clinical project related, strategic and regulatory documents
  • Deliver the medical components of the Clinical Development Plan (CDP) related to the project indication(s) and oversee its implementation
  • Contribute as needed to trial level medical activities
  • As a member of the DSRC for assigned project(s), provide medical input on behalf of TA to the monitoring and analysis of the safety profile of the product, together with Global Drug Safety
  • 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
  • Upon request of management, support the assessment of new in-licensing opportunities
  • Lead the development and maintenance of medical interactions with key external experts and Investigators
  • Lead medical aspects of clinical advisory boards and study specific committees (e.g., steering committees (SC), Independent Data Monitoring Committees (IDMC), 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, patient organization meetings as well as partner meetings where applicable
  • Provide input to and execute publication and clinical communication strategy

Qualifications and Experience:

  • MD with extensive experience in clinical development (including phase 2/3 studies). Therapeutic area of interest: immunology, oncology and CNS.
  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Extensive experience in clinical research in a clinical research organization (CRO) or Pharmaceutical Company (including phase 2/3 studies)
  • Demonstrated experience in overseeing clinical projects from a medical perspective
  • Clinical research experience in the indication relevant to the Clinical Project is preferred
  • Sound knowledge of drug development based on previous deliverables
  • Sound knowledge of regulatory requirements/ICH guidelines
  • Good organizational skills, able to work as part of a cross-functional team and independently
  • Ability to work collaboratively in a matrix environment, Hands-on approach.
  • Strategic thinking
  • Excellent written and spoken communication skills
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