Clinical Project Physician

Reference #: R5650041
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 Bachelors 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 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.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran.Â