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Clinical Project Physician

Viatris
United States Remote Office, United StatesRemotefull_timeVerifiedPosted 12 Aug 2024
💰 $112,000/yr

About the role

Mylan Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via: 

  • Access – Providing high quality trusted medicines regardless of geography or circumstance;

  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 

  • Partnership – Leveraging our collective expertise to connect people to products and services. 

Key responsibilities for this role include:

  • Join our innovative team: Together shape the future with groundbreaking Phase 3 assets, drive blockbuster growth and drive your mission and purpose to bring products to patients.

  • Overall, the Clinical Project Physician (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 represents 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.

  • 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.

  • 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

  • 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 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.

The minimum qualifications for this role are: 

  • Minimum of a Bachelor's degree (or equivalent) and 10 + years of experience.  However, a combination of experience and/or education will be taken into consideration.

  • 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.

  • International travel required.

  • Excellent written and spoken communication skills.

  • Proficiency in speaking, comprehending, reading and writing English is required.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $112,000 - 236,000.

At Viatris, we offer competitive

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Company

Viatris

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