Your tasks and responsibilities
The primary responsibilities of this position, Global Clinical Leader MD, are to:
The Global Clinical Development Leader will be responsible for all strategic (phase II-III) and operational clinical development activities for development projects (phase II - III) or clinical life-cycle management activities for marketed products.
•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 ICMP 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 Project Team representing GCD and member of the Global Brand team, representing GCD
•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 GPL, 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 Global Project Leader (GPL) 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 GCPPL, GIAPL (Global Integrated Analysis Project Leader), Global Regulatory, Medical Science Physician, GDS. 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/SNPM 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 D&C countries together with the global heads of Clinical Operations and Biometry, including patronage countries as needed.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
• MD degree with a minimum of 5 years of experience in Medical Science and Drug Development (from protocol writing to MRR). Board certification in Oncology is preferred, but not required.
• Demonstrated understanding of the drug development and commercialization process
• Key competencies needed by the candidate include the following:
• Proven leadership, motivational and interpersonal skills
• 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
Bayer offers a wide variety of competitive compensation and benefits programs.
If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now.
Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.