Sr Clinical Development Leader Oncology

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Sr Clinical Development Leader Oncology M/F/d**

**YOUR TASKS AND RESPONSIBILITIES**

The Sr Clinical Development Leader will be responsible for all strategic (phase II-III/IV) and operational clinical development activities for Oncology development projects (phase II - III/IV) or clinical life-cycle management activities for marketed products and will also provide late-stage clinical development input for early development assets in phase I. The position will focus on Radium-223 and Targeted Radionuclide Therapies.

**Key Tasks**:

- Leads the Global Clinical Development (GCD) Team, a cross functional, multinational team of internal experts, through clinical phase II - III trials, global product registration, and trials supporting product life cycle optimization. Sets project-related objectives with GCP team members and provides input to their annual performance evaluation (PMP completed by the functional line manager). Requests GCD team members and clarifies resource availability with global functional heads.
- Member of the Global Development Team and representing GCD in related teams, eg Early Development Teams, Global Medical or Commercial Team, PV teams, Due Diligence teams etc.
- In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower).
- Responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved resources. Oversees CRO activities together with clinical operations and proactively initiates corrective action as needed.
- Responsible for the ongoing risk-benefit assessment of a compound until approval in a main country. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate.
- In consultation with the GDL (Global Development Leader) / Head of Clinical Development, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities). Prepares assessments and recommendations at Decision Points and presents them to internal governance / management bodies.
- Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents. Compiles and maintains Investigators’ Brochures (IB).
- Provides medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for early development projects) and defines together with other stakeholders the publication strategy. Approves publications and ensures consistency of publications with clinical data and publication strategy.
- Contributes to Opinion Leader development and publications strategy with implementation detail.
- Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development.
- Provides medical assessment of in
- and out-licensing opportunities of development projects
- Reviews and approves study concepts to ensure compliance with global strategy.

**WHO YOU ARE**
- Highly successful M.D. with extensive professional and academic experience. Board certification in Medical Oncology is preferred
- Proven leadership, motivational and interpersonal skills
- In-depth understanding of the drug development and commercialization process with several years of experience in Oncology Clinical Development.
- Must provide clear vision, direction, and purpose in the different cultures present within the global Medical Organization
- Incumbent must embrace change and be able to work in a changing environment
- Strong communication skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action,
- Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively.

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**YOUR APPLICATION**-
**IMPORTANT NOTE for POTENTIAL CANADIAN CANDIDATES**: This position requires full vaccination against COVID-19.**Location**:

- Switzer