The Company:
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.
The Role:
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.
*MD is not required for this position
Responsibilities:
- 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
Competencies Include:
- 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
Qualifications:
- 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.
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.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from “@nuvalent.com” email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.