The primary responsibilities of this role, Clinical Development Physician MD, are to:
Support Snr/GCL for more complex clinical development programs or responsible for less complex development programs for isolated cases defined by TA Head particularly where there is no assigned GCL;
Co-lead/lead the Global Clinical Team (GCT), 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. Set project-related objectives with GCP team members and provide input to their annual performance evaluation (PMP completed by the functional line manager). Request GCD team members and clarify resource availability with global functional heads;
Prepare the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower). Plan and manage the clinical timelines, manage clinical budget (external clinical grants and CRO management fees), and manpower against the approved CDP and approved resources. Proactively initiates corrective action as needed;
Assess risk-benefit of a compound until approval in a main country. Analyze incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate;
Communicate medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities). Prepare assessments and recommendations at Decision Points;
Support Snr/GCL defining the strategic approach and manage preparation of medical sections of key Regulatory documents (ISE, ISS, expert report). Consult with GCPPL, GIAPL (Global Integrated Analysis Project Leader), Global Regulatory, Medical Science Physician, GDS. Compile and maintain Investigators’ Brochures (IB);
Provide medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and define together with the Marketing Manager/SNPM Manager the publication strategy. Account for internal publication process and ensure consistency of publications with clinical data and publication strategy. Contribute to Opinion Leader development and publications strategy with implementation detail. Establish and maintain appropriate external scientific advisory boards and assists in advocacy development;
Provide medical assessment of in- and out-licensing opportunities of development projects;
Provide oversight of the Clinical Study Teams;
Serve as the escalation decision maker for changes to the agreed study plan.
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:
The incumbent is a highly successful M.D. with extensive professional and academic experience;
Proven leadership, motivational and interpersonal skills;
In-depth understanding of the drug development and commercialization process with a base of experience of 3+ years in Medical Science and drug development (From protocol writing to MRR) (which may include relevant academic experience);
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.
Board certification in a relevant therapeutic area.
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Bayer is an Equal Opportunity Employer/Disabled/Veterans