Nuvalent, Inc.

QA Engineer

• Provide quality oversight throughout the CMC lifecycle management of Nuvalent’s products. Areas may include Starting Materials, Drug Substance, Drug Product or Finished Goods.
• Conduct product release activities for all phases of development, validation, and commercial production including review and approval of master batch records and executed batch records.
• Provide onsite oversight/monitoring of manufacturing campaigns as appropriate.
• Coordinate QP release as appropriate.
• Effectively interact with external contract manufacturers, testing laboratories, and work as part of an internal multidisciplinary team to conduct, review, and approve manufacturing, testing, and product complaint investigations.
• Assist in preparing or reviewing CMC sections of regulatory submissions.
• Supports associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.
• Work with team to implement/maintain Quality Agreements with suppliers.
• Represent the QA department on Vendor project teams.
• Assist in conducting audits of CMOs and Testing Laboratories.

Manager, GMP Quality Assurance

Director

• Partner with GXP business leaders to understand strategic objectives and translate them into comprehensive IT roadmaps that support launch readiness and sustainable operations
• Oversee selection, implementation, and validation of critical GXP systems
• Ensure all IT systems comply with FDA 21 CFR Part 11, EU Annex 11, and data integrity requirements (ALCOA+)
• Lead Computer System Validation (CSV) activities and maintain audit readiness
• Drive IT readiness for commercial launch including system scalability, disaster recovery, and capacity planning
• Build and lead team of IT professionals focused on GXP systems; manage vendor relationships
• Partner with Quality and Regulatory Affairs to support inspections and maintain compliance
• Lead project lifecycle activities such as planning, requirement gathering, design, build, testing, implementation and post-implementation support of GxP applications and related business processes.
• Develop enterprise architecture

Director, IT Business Partner – Biopharma GXP

Marketing

• Develop and execute the brand strategy for zidesamtinib and neladalkib, ensuring launch readiness in 2026.
• Build a best-in-class marketing organization, encompassing product management, digital marketing, market access marketing, and thought leader liaisons.
• Lead brand development efforts, including brand identity, positioning, and messaging, in collaboration with Sales and Market Access teams to design a go-to-market strategy and launch plan.
• Oversee launch tactical planning for personal and non-personal promotion, leveraging innovative strategies to drive brand awareness and patient identification.
• Contribute to revenue forecast benchmarks, performance metrics, and assumptions to ensure effective strategic planning.
• Collaborate with Commercial Operations and other functions to create customer insights strategies, competitive monitoring plans, and market research frameworks.
• Ensure all marketing activities comply with company guidelines, local laws, and industry regulations throughout the launch and commercialization process.
• Partner closely with Commercial and Medical Affairs leadership to align on and execute brand strategy.
• Lead, mentor, and develop a high-performing marketing team, fostering collaboration across the organization and ensuring the successful execution of marketing initiatives.
• Serve as a key member of the U.S. Commercial leadership team, driving the strategic direction and achievement of company-wide goals.

Vice President, Marketing

Manager

• Support drug product Process Validation activities, Scale up and post-approval changes (SUPAC) and routine commercial manufacturing at CDMOs.
• Identify critical process parameters based on the risk assessment and understanding the impact of material attributes and process parameters on critical quality attributes. Implement appropriate process controls to ensure delivery of consistent batch product quality.
• Draft, coordinate, execute validation protocols, perform data analysis, author/review and approve process validation reports with consistent and effective communication with other functions.
• Provide support to routine process validation studies, assisting with product technology transfers or lifecycle management changes such as process improvement, addition of secondary API and manufacture site change etc.
• Perform technical review of drug product manufacture deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for drug product lot release (assess deviations and process changes).
• Work closely with other team members and cross-functionally with quality assurance, analytical/QC, chemical development, supply chain, and project management team to achieve all project deliverables.
• Provide support for technical decision-making regarding cGMP compliance, validation strategy and regulatory pathway for SUPAC changes etc.
• Familiar with statistical analysis software, such as JMP.
• Perform process capability analysis, identify risk, and make recommendations for process improvement.
• Manage documentation, change controls, material inventory, product complaints, and deviation resolution at CDMOs.
• Represent the drug product group as a Subject Matter Expert to support audits and regulatory inspections.
• Support authoring the relevant technical sections of regulatory filings.
• Support late-stage validation and post-approval readiness activities and commercial manufacture activities within a virtual working environment.

Senior Manager, Formulation Sciences

General Counsel

• Serve as a legal advisor on a broad range of commercialization-related subjects
• Serve as an experienced subject matter expert and review committee member for advertising
• Provide legal advisement on the design and implementation of sales and marketing strategy
• Provide ad-hoc advice on contracts with health care fraud and abuse implications
• Advise on commercialization-related contracts and engagements
• Serve as a legal representative on cross-functional project teams
• Assist in the development of the enterprise-wide compliance program

Senior Counsel, Commercial

• Reporting to the Senior Director, Payer & Reimbursement, the Director, Market Access Marketing plays an essential role executing the Market Access strategy, including Payer, Pricing and Patient Support Services strategies.
• Responsible for payer marketing, organized customer marketing, patient support services marketing, and creating market access initiatives.
• Collaborate closely with Sales, HEOR, and Medical Affairs to drive launch readiness and post-launch success.
• Develop compelling value propositions and messaging highlighting clinical benefits, cost-effectiveness and differentiation.
• Manage market access marketing AOR to refine and implement strategy, messaging, and materials.
• Identify and capitalize on strategic opportunities to best position Nuvalent products at National Accounts.

Director, Market Access, Marketing

• Assess and interpret safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports
• Provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PADERs, PBRERs, and clinical safety assessments)
• Support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information
• Contribute to the generation of aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input in review of new or existing safety documents
• Contribute to signaling and safety surveillance processes, including the identification of safety observations, emergent safety concerns and new safety signals
• Serve as a medical resource for the generation and review of clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs)
• Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS)
• Provide safety and pharmacovigilance training programs as required
• Collaborate cross functionally (e.g., Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input

Associate Director, Drug Safety, Pharmacovigilance Scientist

• Provide scientific leadership for all DMPK activities across discovery, preclinical, and development-stage programs.
• Develop and execute DMPK strategies, including ADME, bioanalysis, PK/PD modeling, and in vitro/in vivo metabolism studies.
• Serve as the primary DMPK representative on program teams, influencing strategy, timelines, and go/no-go decision‑making.
• Evaluate DMPK liabilities and optimization strategies for new chemical entities.
• Serve as the DMPK lead on cross‑functional program teams (preclinical, clinical, regulatory, CMC, translational medicine).
• Oversee design, outsourcing, and interpretation of ADME, PK, TK, and metabolism studies conducted under GLP and non-GLP conditions.
• Lead bioanalytical method development and validation to support preclinical and clinical studies.
• Ensure integration of PK/PD modeling and simulation to inform dose selection and clinical study design.
• Build and manage relationships with CROs and external partners, ensuring quality, compliance, and scientific rigor.
• Author and review DMPK sections of regulatory submissions (IND/CTA, IB, briefing packages, NDAs/MAAs).
• Represent the company in regulatory agency interactions (FDA, EMA, etc.) as the DMPK subject matter expert.
• Ensure compliance with all relevant regulatory guidelines, including GLP and ICH.
• Lead DMPK strategy for Nuvalent’s pipeline ensuring data quality that supports INDs, NDAs, and global regulatory interactions.

Senior Director, Drug Metabolism and Pharmacokinetics

• Serve as the clinical pharmacology lead and develop and execute strategies to support Phase 1, registrational, and post‑marketing studies, including designing and leading clinical pharmacology studies.
• Drive the integration of PK, PD, safety, and efficacy data to inform dose selection, dose modification, and labeling recommendations.
• Lead clinical pharmacology contributions to INDs, CTAs, IBs, and NDA submissions.
• Represent clinical pharmacology in interactions with FDA and other global regulators, supporting discussions related to dose justification, pediatric waivers, safety margins, and DDI strategies.
• Partner closely with DMPK, Non-clinical Toxicology, Clinical Development, Biostatistics, CMC, and Regulatory Affairs to ensure cohesive end‑to‑end development plans.
• Oversee population PK modeling, PK/PD modeling, and exposure–response analyses for efficacy and safety.
• Guide quantitative pharmacology approaches supporting optimal dosing in patients.
• Build and mentor a growing clinical pharmacology function as Nuvalent transitions from clinical‑stage to commercial‑.
• Contribute to portfolio prioritization, scenario planning, and long‑range clinical development strategy.

Senior Director, Clinical Pharmacology

Clinical Operations

• Manage multiple aspects of clinical studies working under the guidance and direction of the Clinical Program Lead.
• Accountable for the delivery of project(s) to achieve agreed timelines, scope, quality, and budget.
• Perform oversight of CRO and auxiliary vendors; identify risks and broker solutions.
• Provide support and oversight managing the creation, maintenance and close out of TMF activities.
• Ensure appropriate escalation of enrollment, site activation and data collection milestones.
• Support the clinical team to ensure the completeness of clinical protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
• Ensure site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are adhered to.
• Support database lock by ensuring appropriate oversight of sites and by participating in data review/reconciliation efforts.
• Coordinate with Clinical Supply Chain regarding drug forecasting and supply of drug product to sites.
• Establish and maintain effective communication and collaboration with functional area peers to meet study/program objectives and support goals.
• Lead or co-lead department initiatives to support an expanding organization.
• Travel may be required (10% – 15%).

Manager, Clinical Operations

• Utilizing systematic processes to gather and summarize competitive information that is relevant to Nuvalent's business needs
• Providing context and objective analysis of competitive (commercial, clinical, and scientific) information to enable actions and business decision-making
• Building and updating databases on competitive landscape
• Providing medical conference coverage, some travel may be required
• Evaluating and making recommendations on CI tools, processes, and services, and as needed, manage third party agencies/projects to source relevant CI
• Presenting key competitive information to teams and leadership throughout the organization through oral and written communication
• Participate in the formulation of product/franchise strategies based on data and insights derived from CI, market research, and forecasting analyses.

Senior Manager, Competitive Intelligence

• Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management. Collaborate with cross-functional clinical study team to support clinical study delivery.
• Evaluates, and ensures appropriate oversight of CROs and other external vendors.
• Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals.
• Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals.
• Identify risks and propose solutions to facilitate clinical studies.
• Responsible for review and oversight of the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; contribute to budget forecasting and accruals in collaboration with finance.
• Oversee and manage the creation, maintenance, QC and close out of TMF activities.
• Ensure appropriate oversight of enrollment, site activation and data collection milestones.
• Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms.
• Collaborate with Data Management to ensure timely and efficient database lock. Participate in data review and reconciliation efforts.
• Lead or co-lead department initiatives to support an expanding organization.

Senior Manager, Clinical Operations

Security Operations

• Conducts threat monitoring and analysis using various threat detection, investigation and response capable tools, such as security information and event management (SIEM) and extended detection and response (XDR) platforms.
• Build and maintain security infrastructure, architecture, and system performance.
• Conducts multi-telemetry based threat investigations to identify cyber threats coming both internally and externally of the organization.
• Triages alerts from detection platforms, identifying and removing false positive issues and escalating genuine identified attacks.
• Documents formal, technical incident reports for review by the Director, Cybersecurity and Compliance.
• Provides infrastructure teams with incident support, including mitigating actions to contain activity and advisory for remedial actions.
• Carries out root cause analysis and investigations to advise on prevention mechanisms and configuration changes.
• Works with Threat Intelligence vendors to research emerging threats and exploits to aid in the discovery of incidents.
• Maintains knowledge of latest security technologies and mitigations.
• Carries out analysis and testing for the purposes of identifying vulnerabilities, misconfigurations or other exposures, and the validation of user policies.
• Perform SIEM analysis and ticket handling per service level expectations.
• Create documentation for operational processes.
• Be available for on-call rotation and 24x7x365 support as needed.