The Role:
Reporting to the Head of Analytical Sciences within Technical Operations, the Associate Director, Analytical Sciences has responsibility for the strategic analytical aspects of drug substance and drug product development and manufacturing activities across the relevant Nuvalent CRO and CDMOs for late phase programs. The candidate will interface with the program’s Quality Control, Drug Substance, Drug Product, Quality Assurance, and Regulatory CMC functional representatives. 

The Associate Director, Analytical Sciences will drive analytical strategy for late-stage small molecule oncology programs. This role would entail internal and external facing responsibilities as a technical analytical sciences representative on cross-functional CMC teams, guiding analytical aspects of drug substance and drug product process validation including leading specification strategy, method optimization and validation, and review of related PPQ documentation. The Associate Director will help to develop processes for managing products through Stage 3 validation (continued process verification) and post approval change management. The successful candidate will participate in driving global regulatory CMC strategy for FDA and ex-US interactions and submissions through authoring and review of technical and submission documents. In addition, the candidate will lead analytical support for resolution of regulatory submission inquiries and post-approval commitments. The ability to thrive in a virtual environment in support of developing and delivering drug substance (DS) and drug product (DP) for fast-paced late phase clinical development and commercial programs will be critical. The role will include leading the build-out of Nuvalent’s commercial analytical function focused on technical analytical support of commercial supply and lifecycle management. 

Responsibilities:

•    Define/refine and execute on analytical strategy for a late-stage development candidate.
•    Ensure DS and DP method optimization and ICH method validations are consistent with late-phase expectations.
•    Participate in the strategic definition and justification of late phase-appropriate and commercial SM, Intermediate, DS, and DP specifications.
•    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:
•    Excellent organization, communication, and multi-tasking skills 
•    Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships 
•    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 account-able environment where you can demonstrate initiative and make a clear impact 
•    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 or a PhD in chemistry or related discipline with a minimum of 3-5 years of industry experience 
•    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 late phase small-molecule Drug Substance and Drug Product analytical support of drug development, and commercial and post-approval changes
•    Ability to author and review relevant documentation (methods, protocols, reports) as well as regulatory sections.
•    Technical leadership experience with CROs and CDMOs
•    Mastery of current ICH guidelines and related industry guidelines and practices
•    Excellent organization and multi-tasking skills