Director, Clinical Development
$255k - $345kWave Life Sciences
Director, Clinical Development
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington's disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to "Reimagine Possible", we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
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.
- Board certified MD required
- Formal cardiometabolic and/or hepatology training is preferred
- 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
The annual base salary range for this position is $255,000 - $345,000.
Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge.
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