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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, evaluation and delivery of the dedicated program parts or clinical pharmacology studies; Responsible for the medical/clinical content of key documents for clinical pharmacology program and, therefore, provides input to and review of, as well as the clinical approval for respective clinical documents: protocols, investigator brochures (IBs), IMPDs, study reports, statistical analysis plans, publications, clinical sections of IND/CTA submissions.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
Masters, PhD or M.D. with long term relevant professional and academic experience; Strong track record of designing, executing and delivering excellent, focused clinical development plans and clinical studies to produce both timely and good quality data;Strong track record of achievement and innovation in pharmaceutical medicine: demonstrated understanding of the complexities and recent developments in the medical area(s) germane to the TA; understanding of issues related to the design and performance of technologically demanding trials; confident discussing scientific/mechanistic aspects of drug development; demonstrated ability to present clinical data, development plans and strategies clearly and accurately to relevant audiences;Several years of experience in successful leading and managing cross-functional teams;Exceptional situational leadership skills (both interpersonal and organizational) to build high-performance, productive teams in highly matrixed environment as well as strong mentoring and coaching capabilities;Excellent communication, networking, negotiation and collaboration skills to engage all involved stakeholders across all levels, ability to drive & influence decision making across all levels of the organization, strong stakeholder management capabilities as well as strong network outside of Bayer; Ability to constantly challenge existing paradigms in clinical research and encourage use of breakthrough designs based on an understanding of clinical methods, biomarkers and new technologies (including PK/PD modelling and simulation, physiological measurements, imaging, and biochemical/drug assays);
Preferred Qualifications:
At least 5 years` experience of clinical drug development and/or a relevant therapeutic specialty and/ or in clinical pharmacology. YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
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.