Clinical Project Physician

Location
Basel area
Salary
Competitive
Posted
07 Jan 2019
Closes
15 Feb 2019
Ref
896014-P
Contract Type
Permanent

Main Responsibilities:

  • 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.

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