Director, Clinical Development
About The Position
The Director, Clinical Development is responsible for providing clinical leadership for product(s) in development. This includes the design, planning, execution, scientific integrity, and medical oversight of clinical studies for all phases of development for various therapeutic areas (TA) including cardiometabolic, hepatology, and potentially additional TA programs from early clinical development through regulatory approval. The Director, Clinical Development will collaborate closely with cross-functional partners including Clinical Operations for study design and implementation, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program Management, Preclinical Development and other functions to ensure aligned strategy and execution of all programs. This person will oversee medical monitors and provide medical input to relevant documents (e.g. IB, IMPD, DSUR, SUSAR, IND, NDA/BLA, PIP, etc.). The Director, Clinical Development will be responsible for interpretation and dissemination of study results, including clinical study reports and related publications as well as present data at conferences and other scientific or regulatory forums. This position serves as a core member of the clinical development team, will contribute to devising the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations. They will provide support to translational medicine efforts within assigned TA, working closely with research to define strategy and grow the discovery pipeline. The successful candidate will support the SVP, Clinical Development in providing medical input into the design of clinical development programs, and strategic and tactical plans for investigational products.
Requirements
- Board certified MD required
- 5+ years of industry experience or combined industry/academic experience
- Experience with all stages of clinical development
- Proficient in all aspects of management of clinical trials from inception to completion across all phases of development including study design
- Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management
- Strong scientific background in cardiometabolic diseases
- Expertise in project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems
- Knowledge of FDA and ICH regulations
- Competence in clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
- Familiarity of Good Clinical Practice (CGP)
Nice To Haves
- Formal cardiometabolic and/or hepatology training is preferred
Responsibilities
- Champion product(s) under development
- Serve as a subject matter expert (SME)
- Keep up to date on current literature, competitive environment, and regulatory guidelines
- Provide oversight and management of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Wave SOPs
- Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Wave SOPs
- Review clinical data from all phases of development and assist in generating study reports and publications
- Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other Wave departments (e.g., Regulatory, PV, and Biometrics, etc.) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished
- Serve as study medical monitor, as needed
- Develop and maintain professional relationships with academic and community-based study sites, consultants, HCPs, and KOLs
- Represent Wave in interactions with regulatory agencies
- Provide input and support the SVP, Clinical Development in managing program budgeting and financial planning
- Deliver management personnel with timely updates on progress and changes in scope, schedule, and resources as required
- Develop and implement SOPs for clinical trials and related activities, as required
- Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
- Interface with departments within and outside of R&D including Finance, Legal, etc.
- Analyze and present study data in conferences and scientific forums
- May mentor and manage matrix and direct reports (if applicable)
Benefits
- company-sponsored medical, dental, vision, life, long and short-term disability insurances
- generous paid time off (including a week-long company shutdown in the Summer and the Winter)
- 401K participation with matching contributions
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
