Associate Director, Clinical Science
With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
This is an excellent opportunity for a Clinical Science professional with experience in oncology clinical development to work within a rapidly growing company. The Associate Director, Clinical Science will collaborate cross-functionally and provide hands-on contribution to the design, execution, and reporting of clinical studies, paving a path towards regulatory approval of our precision medicines for oncology targets. This position will report to the VP, Clinical Development.
- Supports the development and revision of clinical development plans (working closely with the medical director, performs literature reviews, competitive landscape analysis, and/or coordinates biostatistical and other subject matter expert input)
- Leads cross-functional development of protocols, protocol amendments, Investigator’s Brochure, clinical study reports, and other key clinical development documents (authors and/or oversees medical writer)
- Writes and/or reviews clinical sections of regulatory applications, submissions, periodic reports, and responses, including responses to EC/IRBs inquiries as appropriate
- Compiles periodic clinical data summaries and assists in interpretation of analyses
- Member of publication planning team; may lead development of clinical abstracts, presentations, and publications
- Ensures methodology for data collection, cleaning, and analyses appropriately enable clinical program goals (may include collaboration with translational development and pharmacology)
- Performs clinical data review and contributes to data cleaning efforts
- Contributes to development of training materials
- Reviewer of key study documents and manuals (CRF, statistical analysis plan, imaging charter, ICF, data management plan, etc.)
- Serves as program team resource: identifies issues and inefficiencies, recommends solutions to challenges, and provides further guidance as needed
- Assists in the creation and continuous improvement of Clinical Development work processes
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
- A strong analytical mind, excellent written/interpersonal communication skills, and the ability to build positive, collaborative, cross-functional working relationships
- Ability to work productively, primarily from home, in a fast-paced, results-driven, highly accountable environment where you can demonstrate initiative and make a clear impact
- 8+ years of experience in the biotechnology or pharmaceutical industry including the design, execution, interpretation and/or reporting of clinical trials in oncology.
- Thorough understanding of the drug development process from IND through NDA, including familiarity with regulatory guidelines and best practices related to clinical trials design, analyses, and reporting.
- Medical writing experience is desired.
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