Senior Director, Early Clinical Leader

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Senior Director, Early Clinical Leader 

The Senior Director, Early Clinical Leader (Clinician) serves as clinical expert for dedicated research or development projects from early research up to after Marketing Authorization. As such, he/she serves in global project teams being accountable for early clinical development up to Proof of Concept. He/ she also serves as Study Medical Expert for dedicated early clinical development studies or clinical pharmacology studies. As ECL, accountable and responsible for planning, content, execution, and delivery of early clinical development plan from PCC to Proof of Concept (PoC) for new drug candidates.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of the Senior Director, Early Clinical Leader are to:

• Accountable and responsible for coordinating the design, execution and delivery of the early clinical development plan, through PoC as well as the clinical pharmacology plan in partnership with other functions and the Global Clinical Lead (GCL), with input from and consensus with other groups e.g. Research Groups, Early Development, Regulatory Affairs, and commercial functions;
• Works as an internal expert opinion in Target ID teams or early research teams, providing medical/ clinical expertise in order to identify and assess intended indications, patient(sub)populations and drug targets within the global Bayer strategic frames;
• Starting during early preclinical research, he/she provides early clinical development concepts or plans for the respective milestones;
• Starting prior to PCC, he/she ensures definition of an early clinical development and related clinical pharmacology plan, their milestones and, in particular, go/no go decisions and PoC deliverables which fits to the overall therapeutic area strategy;
• Ensures the appropriate inclusion of biomarkers and new clinical methodology/technology in close liaise with partner functions such as Disease Understanding Precision Biomarker (DUPB);
• Provides the medical/clinical assessment justifying the First-in-Man application for approval by the Joint FiM/Tox Release Conference;
• Responsible for the ongoing benefit/risk assessment from FiM until PoC, based on the thorough clinical understanding of the targeted indication and the medical need, the medical/clinical interpretation of study data, and additional relevant medical and scientific information. Further responsible for initiating actions or decisions as appropriate with respect to the ongoing benefit/risk assessment;
• Responsible for expert panel meetings and advisory boards to give input into early clinical development and clinical pharmacology plans;
• Provides input, final review as well as the clinical approval for clinical documents: e.g. study protocols, investigator brochures (IBs), study reports, statistical analysis plans, publications, clinical sections of IND/CTA submissions;
• Actively involved in interpretation of clinical and clinical pharmacology data and formulation data-driven development decisions, with full responsibility for all clinical/medical aspects;
• Presents to senior management and external audiences on early clinical and clinical pharmacology aspects of compound development, specifically milestones, strategies, and study results with conclusions and interpretation;
• Provides medical/clinical assessment of in- and out-licensing opportunities of research and development projects;
• As study medical expert they remain responsible for a global project after PoC until after Market Authorization for drug candidates. As such, you will then becomes member of the clinical team and takes over responsibility for medical/ PD aspects of the clinical pharmacology program including respective studies or other clinical pharmacology activities. In this role and have full medical/clinical responsibility for assigned drug candidates i.e. the design planning, content, execution, evaluat