Associate Director, Analytical Sciences

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:

The Associate Director, Analytical Sciences will lead analytical activities for a late-stage small molecule oncology program. This role would entail internal and external facing responsibilities as the technical subject matter expert (SME) for analytical sciences on the cross-functional CMC team and through analytical leadership of key external CMO relationships.

The successful candidate needs to demonstrate a proven track record of working with CROs/CMOs to support drug development through the delivery of high-quality analytical methods, process support, and stability studies. The ability to thrive in a virtual environment in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced clinical development programs will be critical. In addition, using strategic thinking, strong technical analytical experience, and an effective knowledge of industry regulatory guidance, the candidate will support DS and DP development efforts, drive later-stage specification strategy, define, and manage stability programs, and contribute to the authoring and review of regulatory submission documents and key Regulatory Agency interactions.

Reporting to the Head of Analytical Sciences within Pharmaceutical Development, the Associate Director has responsibility for the analytical aspects of drug substance and drug product development and manufacturing activities across the relevant Nuvalent CRO and CDMOs. The candidate will interface with the program’s Quality Control, Drug Substance, Drug Product, Quality Assurance, and Regulatory CMC functional representatives. Responsibilities include ensuring that drug substance and drug product analytical support is timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team.

 

The successful candidate will drive value through the following areas/interactions:

Responsibilities:

• Define/refine and execute on analytical strategy for a late-stage development candidate.
• Ensure DS and DP method optimization and ICH method validation.
• Technical review of documents for analytical development, characterization, release, and stability. Interface with QC for review for completeness, accuracy, and consistency with specifications as applicable.
• Design and execution of phase appropriate stability studies.
• Maintain shelf-life extension strategy for Nuvalent Product
• Contribute to the analytical/QC technical aspects for all or portions of a program on a CMC team.
• Participate in the strategic definition and justification of phase-appropriate SM, Intermediate, DS, and DP specifications.
• Monitor release and stability trend results as part of product and method life cycle management
• Participate as needed on investigation teams as the analytical SME.
• Author and review analytical-relevant regulatory submission documents.
• Author and review relevant change controls and SOPs.

Competencies Include:

• A strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines with the ability to apply them to analytical DS and DP development and manufacturing is required.
• Expertise in small-molecule Drug Substance and Drug Product analytical method development, registration stability design, and support of process/method validation
• Experience with development and validation of a discriminating dissolution method for solid oral dosage forms.
• Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections.
• Proven track record solving analytical and QC challenges with a focus on small molecules.

 Qualifications:

• BS or equivalent in chemistry or related discipline with 10-15 years of relevant industry experience
• PhD in chemistry or related discipline with a minimum of 3-5 years of industry experience
• Technical leadership experience with CROs and CDMOs
• Mastery of current ICH guidelines and related industry guidelines and practices
• Excellent organization and multi-tasking skills
• Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships.

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without