Manager, Clinical Sciences
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal 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 Manager, 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.
- As a member of cross-functional study management team, partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.
- Supports Medical Monitor and Clinical Operations teams in day-to-day data related questions/issues.
- Performs clinical data review and contributes to data cleaning efforts (may include collaboration with translational development and pharmacology); monitors data issues requiring clinical input
- Compiles periodic clinical data summaries and assists in interpretation of analyses
- Contributes to development of training materials
- Reviewer of key study documents and manuals (CRF, statistical analysis plan, imaging charter, ICF, data management plan, etc.)
- Facilitate generation of, author, update, and/or review key documents including protocols/amendments, Investigator’s Brochure, clinical study reports, and clinical sections of regulatory applications, submissions, periodic reports, and responses, including responses to EC/IRBs inquiries as appropriate
- 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)
- 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
- 5+ years of experience in the biotechnology or pharmaceutical industry
- Familiarity with regulatory guidelines (GCP, ICH) and best practices related to clinical trials design, analyses, and reporting, ideally including prior involvement in oncology clinical development program in a clinical scientist role
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
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