Clinical Research Physician

Vor 5 Tagen

Zug, Zug, Schweiz Viatris Vollzeit

About the Role

The Clinical Project Physician will provide medical leadership and oversight for clinical development projects from concept generation to design, implementation, execution, and submission/approval. This role will represent the medical lead for the specific assigned project in the life cycle teams.

Key Responsibilities

  • Provide medical leadership internally for all TA-responsible project activities, including LCT, Clinical Team, Regulatory & Safety aspects.
  • Provide medical and scientific input 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 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.
  • Ensure project(s) 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.
  • Support the assessment of new in-licensing opportunities upon request of management.
  • 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.
  • 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 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.

About Your Skills & Experience

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:

  • Qualified MD.
  • Extensive experience in clinical research in a clinical research organization (CRO) or Pharmaceutical Company.
  • 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.
  • Strategic thinking.
  • Hands-on approach.
  • Excellent written and spoken communication skills.
  • Fluent in English (written and oral).

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others. Some of our benefits include:

  • Excellent career progression opportunities.
  • Work-life balance initiatives.
  • Bonus scheme.
  • Health insurance.
  • Pension.

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