Associate Director, CMC Regulatory Affairs
Wave Life Sciences USA seeks experienced and highly motivated individual to join its Clinical Operations team in Lexington, Massachusetts. The ideal candidate will focus on assuring requirements of duties to be fulfilled within a team-oriented, fast-paced and cross-disciplinary biotech environment.
Manages overall operation of the entire clinical study including project planning, budget, resource management, contract research organization, and vendor management. Manages clinical operational plan, and incorporates the study and scientific plan. May develop study related documents and overall direction for the clinical sites to establish protocol adherence. Ensures compliance with good clinical practices, good manufacturing practices and regulatory guidelines. Recommends and implements innovative process ideas to impact clinical trials management. May develop and manage clinical budget and develop contingency plans for clinical trials. Oversees clinical trials staff and CROs, and manages all aspects of clinical operational plan. Responsible for managing full scope of study. Acts as a cross functional liaison to ensure study plan aligns with business development strategies.
- Excellent team player, self-motivated and comfortable working in a matrix environment, with minimal oversight.
- Able to lead internal and external global, multi-disciplinary teams /CRO study management teams to ensure the successful conduct of clinical trials in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
- Able to prioritize multiple deliverables effectively
- Manage the supervision of contracted clinical research organizations, clinical laboratory vendors, and other outsourced work
- Author and review as needed clinical study documents (Informed Consent Forms, Clinical Study Plans, Case Report Forms, Statistical Analysis Plan, etc.). Review and contribute as needed to Investigator's Brochure and other supportive regulatory documents
- Drive IRB/ethics committee and regulatory submissions as needed to support study timelines
- Effectively evaluate qualified study sites, perform site initiation, plan and present at investigator meetings/advisory boards, and implement study start up activities including development of documents related to conduct of the study in collaboration with the clinical study team Manage and review study budgets and investigator grants
- Assess study drug requirements and shipment logistics; contribute to labeling strategy
- Responsible for timelines (from initiation to closure) ensuring they are met
- Proactively identifies project risks and resolves with some supervision.
- Much of the above may be delegated to CROs, in which case the candidate should manage the CROs effectively to ensure delivery)
Education / Experience:
- B.A./B.S. in a scientific, healthcare or related field. Advanced degree preferred, but not required.
- Minimum 3 years of clinical trial experience in Pharmaceutical, Biotech or CRO company preferred
- Travel will be required
- Experience with rare diseases a plus