Compound Leader (US)
Department: R&D
Job Title: Compound Leader ( Senior Director or VP)
Report to: CMO
Location: US
MAIN REPONSIBILITIES:
- Act as scientific and product leader who serves as a key member of the core R&D Team and responsible for the overall preclinical and clinical development plan for an asset or assets in one or more indications/tumor types, including registrational and non-registrational studies.
- Lead the different functions as product Lifecycle leader within the Clinical Team with his/her expertise and leadership (monitoring, preclinical, data management, biostatistics, medical, clinical, pharmacovigilance, regulatory affairs, QA, CMC) as well as interact with and support Project team members.
- Ensure that studies are aligned with target label indications and commercial goals, and are properly designed and conducted.
- Ensure that the operational development process is aligned with Company standards and help to review and improve current SOPs.
- Inspire the team to strive for excellence in clinical design, execution, interpretation and successful filing and approval in relevant markets.
- Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities.
QUALIFICATIONS:
- MD preferably with a background in clinical oncology or regulatory professionalism. PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge.
- At least 8 years of relevant experience, with excellent skills & knowledge with a whole/intense view of drug development and regulatory approval.
- Demonstrated leadership in understanding of the drug development and in cross functional working.
- Outstanding oral and written communication skills and ability to interface effectively with all levels.
- Excellent oral and written English.
