Essential Functions of the Job (Key responsibilities)
• Contribute to the development of clinical development strategy for development assets
• Lead the the scientific execution of global clinical studies, including the planning, design, implementation and execution of clinical programs and the design, preparation and initiation of study protocols.
• Have accountability for delivery of clinical study plan along with clinical operations lead that are aligned with the clinical development plan and are ethical and consistent with standard of care and local practices.
• Support data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts. Interpret clinical data; research, interact with and select investigators for clinical studies and post approval support (US and globally) and supply information on resource requirements to relevant groups.
• Serve as an internal expert with regard to the science of the field, the competitive landscape in research, and the current state of treatment in areas of unmet medical need.
• Review potential in-licensing candidates and present recommendations to Senior Management groups, if requested. Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
• Identify, engage and liaise with investigators and key opinion leaders regarding program strategy and scientific advice.
Qualifications (Minimal acceptable level of education, work experience, and competency)
• MD with advanced clinical training
• Minimum 5 years’ experience in the pharmaceutical industry or related field
• Experience includes a clinical leadership role on a drug development project team
• Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills.
• Analytical and problem-solving skills; detailed oriented, an independent and critical thinker.
• Excellent communication skills and written, verbal and presentation skills. A credible ‘thought leader’ capable of inspiring others and creating a dynamic environment that fosters innovation in thought and execution, as well as transparency.
• Experience in late-stage drug development (Phase 2, 3, and 4)
• Previous regulatory submission experience a plus (e.g., IND, NDA, MAA, PIP)
• Self-motivation and entrepreneurial spirit
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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