Director, Early Clinical Leader - Cardiovascular and Kidney

 

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.

 

Director, Early Clinical Leader - Cardiovascular and Kidney 

 

The Director, Early Clinical Leader (Clinician) serves as a clinical expert for dedicated research or development projects from early research up to after Marketing Authorization. In this role, you will be accountable for early clinical development up to Proof of Concept and serves as the Study Medical Expert for dedicated early clinical development studies or clinical pharmacology studies. As ECL, he/she is responsible for planning, content, execution, and delivery of the early clinical development plan from PCC to Proof of Concept (PoC) for new drug candidates.

 

YOUR TASKS AND RESPONSIBILITIES

 

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

 

• Be accountable 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 groups such as Research, Early Development, Regulatory Affairs, and commercial functions;
• Serve as an internal expert in Target ID teams or early research teams, providing medical/clinical expertise to identify and assess intended indications, patient (sub)populations, and drug targets within Bayer's strategic framework;
• Provide early clinical development concepts or plans for respective milestones starting during early preclinical research;
• Ensure the definition of an early clinical development and related clinical pharmacology plan, milestones, and go/no-go decisions prior to PCC that align with the overall therapeutic area strategy;
• Ensure appropriate inclusion of biomarkers and new clinical methodologies/technologies in close collaboration with partner functions such as Disease Understanding Precision Biomarker (DUPB);
• Provide the medical/clinical assessment justifying the First-in-Man application for approval by the Joint FiM/Tox Release Conference;
• Conduct ongoing benefit/risk assessments from FiM until PoC, based on thorough clinical understanding of the targeted indication and medical need, as well as medical/clinical interpretation of study data and additional relevant information;
• Lead expert panel meetings and advisory boards to provide input into early clinical development and clinical pharmacology plans;
• Provide input, final review, and clinical approval for clinical documents, including study protocols, investigator brochures (IBs), study reports, statistical analysis plans, and clinical sections of IND/CTA submissions;
• Actively interpret clinical and clinical pharmacology data to formulate data-driven development decisions, taking full responsibility for all clinical/medical aspects;
• Present to senior management and external audiences on early clinical and clinical pharmacology aspects of compound development, including milestones, strategies, and study results with conclusions and interpretations;
• Assess medical/clinical implications of in- and out-licensing opportunities for research and development projects;
• Remain responsible for a global project after PoC until after Market Authorization for drug candidates, taking on responsibilities for medical/PD aspects of the clinical pharmacology program, including respective studies or activities;
• Ensure the medical/clinical content of key documents for the clinical pharmacology program, providing input and review, as well as clinical approval for respective clinical documents;

 

WHO YOU ARE

 

Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

• M.D. with long-term relevant professional and academic experience;
• Strong t