YOUR TASKS AND RESPONSIBILITIES:
- Leads the Clinical Development (CD) Team, a cross functional, multinational team of internal experts, through clinical phase II III trials, global product registration, and ICMP trials supporting product life cycle optimization.
- Sets project related objectives with GCD (Global Clinical Development) and IP (Integrated Product) team members who will provide input to the annual performance evaluation (PMP completed by the functional line manager).
- Requests CD team members and clarifies resource availability with global functional heads.
- Member of the Global Development Team representing CD , representing CD 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.
- 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 Head of the Therapeutic Area (TA) and Global Development Leader (GDL), 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 together with the GDL to the Development Management Committee.
- Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (ISE, ISS, expert report). Consults with internal stakeholders as eg. , Global Regulatory, Medical Science Physician. Compiles and maintains Investigators Brochures (IB).
- Provides medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and defines together with the Marketing Manager/ 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.
- Approves domestic study concepts to ensure compliance with global strategy.
- Allocates studies to the countries together with the global heads of Clinical Operations and Biometry, including patronage countries as needed
WHO YOU ARE:
- A highly successful M.D. with extensive professional and academic experience. Board certification in Medical Oncology is required.
- In-depth understanding of the drug development and commercialization process with a base of experience of 5+ years in Clinical Development
- Proven leadership, motivational and interpersonal skills
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Bayer is committed to providing barrier-free access and support-facilities for individuals with disabilities - during the application process and beyond. Applicants with disabilities are encouraged to request any support / equipment they may need via the contact information below.
Switzerland : Basel-City : Basel