Nuvalent

Role Description Reporting to the Senior Director, Thought Leader Strategy & Partnerships, the Director, Thought Leader Liaison will be a pivotal partner in Nuvalent’s growing Commercial organization. This individual will spearhead the execution of the thought leader engagement as the company prepares for the market launch of Zidesamtinib and Neladalkib. The Director will be a pivotal member of the Commercial and Marketing teams. This role will provide guidance on thought leader relationships and partnerships ensuring alignment with brand objectives and coordinating end-to-end relationships for the Commercial organization. This individual will also support the execution of brand strategies to ensure launch readiness. Responsibilities - Develop and execute a comprehensive Commercial engagement strategy for lung cancer thought leaders, including academic researchers, digital opinion leaders, and other key influencers. - Collaborate with internal teams to implement commercial strategies and manage interactions with key accounts, ensuring alignment with Nuvalent’s business goals. - Capture valuable therapeutic and competitive insights from Thought Leaders and other key stakeholders to guide impactful field insights integration that shapes positioning, messaging, and stakeholder engagement strategies. - Work closely with the Senior Director, Thought Leader Strategy to aggregate insights and determine implications to the brand and disseminate as part of the Insights Team. - Work closely with internal teams to execute commercial launch strategies, managing interactions with Thought Leaders throughout the process. - Identify and engage promotional speakers to represent Nuvalent at regional and national events. - Identify and nominate promotional speakers for the brand Speaker Bureau. - Cultivate and maintain strong, trusting relationships with Thought Leaders, ensuring they are well-informed about Nuvalent’s activities, portfolio, and strategic direction. - Partner with Legal and Compliance teams to enforce guidelines and processes for compliant customer engagement. - Serve as a point of coordination, facilitating connectivity across internal stakeholders in collaboration efforts to become a preferred industry partner. - Co-lead and execute Commercial Advisory Boards in partnership with Head, Thought Leader Strategy and internal cross-functional collaborators. - Execute the Thought Leader Engagement Congress strategy. - Support brand initiatives with KOL needs (i.e., KOL videos, Peer to Peer programs, Product theaters). - Compliantly support Field needs to include, but not limited to: KOL introductions, speaker bureau nominations, KOL expert panels at sales meetings. Competencies Include - Foster a culture of empowerment, collaboration, and a focus on patient impact. - Strong scientific and clinical orientation, comfortable with data, and ability to distill complex clinical information into business implications and credible narrative with internal and external stakeholders. - Exceptional communication and influence skills, with the ability to inspire confidence and work successfully with varied stakeholders including the Brand Team and Product Development Team. - Proficient in multichannel marketing directed towards HCPs and patients, including digital, media, peer-to-peer, congresses, and personal promotion tactics. - Drives for results and nurtures a performance-based culture of continuous improvement, addressing concerns and conflict proactively. - Characteristics include being entrepreneurial, collaborative, and an energetic initiative-taker with strong interpersonal and analytical skills. Qualifications - Bachelor’s degree. Advanced degree preferable. - 10+ years biopharma experience including oncology launch experience. - 3+ years as a Thought Leader Liaison in Oncology. - 5+ years of commercial oncology experience in the U.S. market, with expertise in sales, marketing, or related functions. - Demonstrated ability to manage multiple projects simultaneously, prioritize effectively, and communicate across all organizational levels. - Proven track record of recruiting, onboarding, managing, coaching, and retaining top talent, with strong leadership and mentorship skills. - Strong understanding of analytics and operations tools/technologies. - Excellent written and verbal communication skills, including presentation abilities. - Willingness to travel up to 50% domestically. Preferred Qualifications - Experience in Lung cancer is highly preferable. - Prior Thought Leader Liaison engagement and/or scientific exchange in Lung Cancer. Benefits - Medical, dental, and vision insurance. - 401(k) retirement savings plan. - Generous paid time off (including a summer and winter company shutdown). - Comprehensive benefit package to support employees at each stage of their career, financial, health, and well-being journey.

Role Description Reporting to the Director of Quality Control, the Manager, Quality Control will be responsible for managing the analytical Reference Material & Reference Standards (RMRS) program at Nuvalent. The candidate will ensure the program is in compliance with Nuvalent policies, standards, procedures and global cGxP to support clinical and commercial operations. In addition, this role will provide leadership of reference material lifecycle management, qualification/re-qualification of RMRS, change management and continuous improvements in the Analytical/QC group and Technical Operations Department. 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, and to coordinate commercial readiness deliverables will be critical. As the Quality Control expert, the candidate is accountable for ensuring all company, regional, and global GMP and GDP standards and regulations are met, and that the GMP Quality Control department performs to a standard that ensures the quality of products and materials produced by our contracted partners. The candidate will interface with the program CMC Cross-functional representatives to ensure that RMRS QC support is timely, high quality, and consistent with the Phase-Appropriate strategies outlined by the project team and CMC Team. Responsibilities - Collaborate closely with the functional teams to support the synthesis, certification, release, and management of associated reference material. - Manage the RMRS material inventory database. - Work with internal teams, CMOs, and Test Labs to assemble data packages in support of RMRS management. - QC review of RMRS analytical data for completeness, accuracy, consistency with specifications and/or protocol design as applicable. - Tabulate, assess, and archival of qualification/re-qualification testing data to help understand degradation pathways in aid of product life cycle. - Support the qualification and management of GxP vendors for RMRS synthesis and related analytical work as applicable. - Investigate and resolve analytical test failures (OOS and atypical results) with support of cross-functional team. - Author and/or review relevant sections of regulatory submission documents, as well as author and review relevant change controls and SOPs. Competencies Include - Excellent organization and multi-tasking skills and ability to drive and deliver multiple projects within project scope and timelines. - Ability to think critically with strong attention to detail. - Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands. - Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people. - Clear professional communication and presentation skills. Qualifications - Bachelor’s degree or equivalent in chemistry or related discipline with 4+ years of relevant industry experience with at least 2 of those years at the QC Manager level. - Ability to work with all levels of organization and external contract service providers to ensure compliance with current regulations. - Knowledgeable in CGMP regulations and ICH or other industry guidance. - Proven track record solving analytical and QC challenges with a focus on small molecules. - Proficiency with JMP and application of statistical analysis concepts is strongly preferred. - Prior stability program management experience is a plus. Benefits - Medical, dental, and vision insurance. - 401(k) retirement savings plan. - Generous paid time off (including a summer and winter company shutdown). - Comprehensive benefit package to support employees at each stage of their career, financial, health, and well-being journey. Annual Salary Range $125,000 — $145,000 USD

Role Description Reporting to the Associate Director, Analytical Sciences, the Senior Scientist, Analytical Sciences, has responsibility for the analytical aspects of drug product development and manufacturing activities across the relevant Nuvalent CRO and CDMOs. The candidate will interface with the program’s Quality Control, Drug Product, Quality Assurance, CMC Project Manager and Regulatory CMC functional representatives. Responsibilities include ensuring that drug product analytical support is timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team. The candidate will support analytical activities for a clinical small molecule oncology program. This role would entail internal and external facing responsibilities as a member of the analytical sciences group on the cross-functional CMC team and through analytical leadership of key external CRO/CDMO relationships. The successful candidate needs to demonstrate a proven track record of working with CROs/CDMOs to support drug product 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 product for fast-paced clinical development programs will be critical. In addition, using strong technical analytical experience and effective knowledge of industry regulatory guidance, the candidate will support phase appropriate drug product development efforts, dissolution development, contribute to the analytical strategy and assist in the authoring and reviewing technical regulatory submission documents. Responsibilities - Lead drug product analytical method development and method validation for a clinical development program. - Author and review method development, method transfer, method validation, specification, justification of specification, and regulatory source documents. - Oversee and manage CDMO counterparts through analytical method development as well as analytical routine activities to support drug product manufacturing (release and stability testing, batch record review). - Provide internal and external leadership through management of quality events such as deviations, OOS/OOT, investigations, CAPA, etc. - Support the design of drug product stability studies, retest and shelf-life document strategy and execution. - Support analytical aspects of RSM and drug substance development and phase appropriate method validation. - Work within a cross-functional team to help design and execute control strategies in support of novel clinical therapeutics. - Assist in global regulatory CMC activities through authoring and reviewing technical and submission documents. - Integrated member of cross functional CMC team. Qualifications - 6-8 years of experience in industry or CRO. - BS or equivalent in chemistry or related discipline (3-5 years’ experience with a PhD in chemistry or related discipline). - Hands-on experience in small molecule analytical methods and method validation (HPLC, GC, LC-MS, dissolution, KF, forced degradation, etc.). - Strong scientific writing experience with the ability to author and review relevant documents (methods, protocols, reports). - Proven track record of technical contributions in a virtual environment, including working with/leading CROs and CDMOs. - Knowledge of relevant industry guidance for US and Global products and regulatory guidelines (FDA and EMA). - Knowledge of ICH guidance and pharmacopeias (USP, EP, JP, etc.). - Ability to solve analytical and QC technical challenges. - Novel drug development analytical experience. Benefits - Competitive total rewards packages. - Comprehensive benefit package including medical, dental, and vision insurance. - 401(k) retirement savings plan. - Generous paid time off (including a summer and winter company shutdown). Annual Salary Range $140,000 — $160,000 USD

• Partner with IT, Quality, Regulatory, Clinical, TechOps, Pharmacovigilance, and vendors to support GxP system implementations, enhancements, and upgrades. • Develop, maintain, and continuously improve CSV policies, SOPs, and forms aligned with regulatory expectations and industry best practices. • Ensure application of risk-based validation approaches and data integrity principles (ALCOA++). • Act as CSV subject during internal audits, vendor audits, and regulatory inspections. • Review and approve GxP system validation deliverables, change controls, deviation investigations, and periodic reviews. • Assess inspection trends and proactively update validation practices accordingly. • Evaluate vendor documentation for GxP system validation and SDLC for suitability and leverage where appropriate.

• Serve as the primary contracts professional working closely with the Clinical function • Manage the full contract lifecycle from initial draft through execution, amendment, and close-out • Draft, review, negotiate, and execute Clinical Trial Agreements (CTAs) • Coordinate Informed Consent Form (ICF) review as needed • Negotiate and process Work Orders (WOs) and Change Orders (COs) • Maintain accurate, complete, and timely contract records in Nuvalent’s contract management system

• Reporting to the Head of Nuvalent Medical Affairs, the Senior Director of Medical Affairs Operations will serve as a strategic thought partner to the Head of Medical Affairs and the Medical Affairs Leadership Team (MALT). • Provide operational leadership, discipline, and alignment across Medical Affairs, ensuring that objectives, processes, and resources are optimized to deliver impact at scale. • Drive operational excellence, enable cross-functional collaboration, and oversee field operations, insights, and analytics to support the organization’s growth and transformation. • Act as a trusted advisor to the Head of Medical Affairs and MALT, shaping operational strategy and execution. • Lead KPI and objectives planning, tracking, and reporting to ensure accountability and transparency. • Develop dashboards and reporting frameworks to provide real-time visibility into Medical Affairs performance, risks, and resource utilization; establish frameworks for measuring impact and continuous improvement. • Define and evolve ways of working within Medical Affairs, including process development, capability building, and cross-functional orchestration. • Oversee budget planning, forecasting, and resource allocation to ensure fiscal discipline and strategic investment. • Identify, assess, and mitigate operational risks, ensuring proactive management and transparent escalation to leadership. • Craft and deliver executive communications that synthesize operational performance, risks, and strategic initiatives for senior leadership and board audiences. • Support and enable key initiatives such as regional expansion, organizational transformation, and business model evolution.

• Reporting to the Director, Global Regulatory Affairs, the Senior Manager, Regulatory Affairs role will integrate regulatory strategic development, submission management expertise, and hands-on execution to support the IND/CTA stage of development through NDA/MAA. • Contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). • Manage the preparation, submission and internal review and approval of regulatory documents, including providing technical regulatory input for global documents to streamline development. • Ensure current, innovative, and compliant regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA. • Participate as a regulatory representative for Clinical Study Team (CST) on development programs assigned working closely with product development team (PDT) lead to develop the global regulatory strategy; work closely with regulatory operations and program management to track timelines and ensure deliverables are achieved • Support preparation, review, compilation, and execution of submissions for regulatory agencies for US and ROW (e.g., IND/CTAs, NDA/MAA, DSURs, Amendments, and Responses to Regulatory Agency Requests for Information, etc.) • Provide regulatory guidance and support to senior regulatory affairs members on various projects, as needed, to further development programs (pediatric development planning, regulatory interactions, NDA planning) • Ensure collaboration with and coordination of cross-functional project teams for timely execution of regulatory submissions, maintaining compliance with global regulatory standards and commitments, and providing regulatory guidance and oversight • Support regulatory operations during the regulatory submissions handoff process, as the primary point of contact for external publishing vendors, ensuring submission packages are accurate, formatted correctly, and validated. • Maintain the regulatory information system and ensure proper archiving, searchability, and accessibility of regulatory content including correspondence with regulatory agencies • Manage regulatory submission processes, develop and maintain regulatory tracking tools and infrastructure, as assigned. Conduct regulatory intelligence and competitive intelligence and summarize key impacts to global strategy development teams, as appropriate • Ensure compliance with internal SOPs, regulations and applicable laws. Drafts and reviews Regulatory Affairs SOPs and work instructions and provides Regulatory feedback on other departmental SOPs, where required

Role Description Reporting to the Director of Supply Chain Management, the Associate Director, Supply Chain Logistics & Compliance will lead import/export, trade compliance and support global logistics in a dynamic, fast-paced, team-oriented, and collaborative environment. This role is responsible for ensuring compliance, efficiency, and cost-effective cross-border movements of goods, while supporting global supply chain strategies, regulatory requirements, and commercial objectives. The ideal candidate brings subject matter expertise in import/export processes, customs compliance, and global distribution networks, along with proven leadership expertise. This position will allow for growth within the company and contribute to your valuable experience in establishing policies and procedures for the Supply Chain department during a critical time. You will work closely with many cross-functional areas and will be able to contribute to their practices for a more efficient, cost-effective, and compliant supply chain. Our fast-paced environments and hands-on opportunities will challenge you to innovate and learn while having fun with supportive and passionate colleagues. Responsibilities - Lead Import/Export activities, ensuring full compliance with global customs regulations, export controls, and trade sanctions. - Oversee product classification (HTC) valuation, country of origin, and accurate preparation of shipping documentation. - Develop, implement, and continuously improve global trade compliance processes, SOPs, and internal control mechanisms. - Direct liaison with customs authorities, brokers, and regulatory agencies. - Monitor and interpret evolving global trade regulations, ensuring timely implementation of changes. - Design and manage global distribution networks to support commercial and clinical supply needs. - Drive optimization of routes, carriers, and distribution models to balance cost, speed, and compliance. - Establish and track KPIs such as customs clearance time, on-time delivery, cost per shipment, and compliance metrics. - Ensure visibility across the supply chain through tracking and proactive exception management. - Identify and mitigate risks related to cross-border shipments including delays, regulatory issues, and geopolitical factors. - Ensure adherence to cGMP and GSP/GDP regulations. - Partner with Quality and Regulatory to support inspections and ensure audit readiness. - Demonstrated leadership experience in global distribution and cross-border operations. - Advanced knowledge of international trade regulations, customs compliance, and export control framework. - Strong understanding of Incoterms, tariff classification, customs valuation, and documentation. - Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, 21 CFR Part 11, and Annex 6, 13) and knowledgeable of relevant commercial laws and regulatory guidelines. Qualifications - Bachelor’s degree in business administration, Operations Management, Engineering or similar required; Advanced degree preferred. - 10+ years progressive experience in logistics within the biotech/pharmaceutical industry with strong emphasis on import/export and trade compliance. - Due to the global nature of the company, early morning or evening meetings are required. Potential Travel: 10%. - Experience in change management, deviation investigation, and CAPA implementation. - Experience in vendor oversight and managing external partnerships and relations. - Experience with small molecule supply chain. - Experience with lane risk assessments, and shipping lane/process qualification including IQ, OQ, PQ. Benefits - Medical, dental, and vision insurance. - 401(k) retirement savings plan. - Generous paid time off (including a summer and winter company shutdown). - Comprehensive benefit package to support employees at each stage of their career, financial, health, and well-being journey. Company Description 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.

• Manage and support the relationship with safety vendor(s) to ensure effectiveness, quality and compliance of all outsourced activities. • Provide Sponsor oversight of operational safety responsibilities, including the timely and accurate execution of the processes defined within the applicable Safety Management plans. • Monitor performance (metrics, other reports) of the safety vendor and the quality output of the ICSRs; provide appropriate feedback and training. • Monitor key performance indicators of case processing and present findings to Head of PV and cross-functional stakeholders. • Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs. • As needed. review incoming adverse event reports and communications from vendors to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports. • Oversee case workflow (case receipt through submission) between safety vendor and Nuvalent Pharmacovigilance team. • Ensure safety case queries are resolved as per defined processes (interfacing with safety physicians, clinical operations team, other cross-functional teams within Nuvalent, and clinical vendors, as required) and facilitate case closure within required timelines. • Serve as PV operations SME on safety reporting processes according to study protocol. • Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices. • Serve as resource and contact for other functions within the company for pharmacovigilance operational activities. • Serve as Pharmacovigilance representative for the operational aspects of the SAE reconciliation.

Role Description Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Medical Director, Drug Safety and Pharmacovigilance is responsible for the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. The individual will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety reports (e.g., DSURs, PSUR and clinical safety assessments). The individual will be an integral part of a group of safety professionals within Nuvalent and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices. Responsibilities - Provide medical expertise in the assessment of ICSRs - 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 to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports - Contribute to signaling and safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, ensure prompt assessment and communication of confirmed safety signals - Serve as a medical resource for the generation and review clinical trial protocols, informed consent forms (ICFs) and investigator brochures (IBs) and the development of Reference Safety Information - Contribute to creation or and updates to Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) and the maintenance of these documents - Contribute to the development of Standard Operating Procedures, Working Instructions and other guidance documents - Provide safety and pharmacovigilance training programs as required - Collaborate cross functionally (e.g. Reg Affairs, Clin Ops, Clin Science) to ensure pharmacovigilance input - Support other pharmacovigilance and drug safety responsibilities as assigned Competencies Include - Strong written/verbal communication skills - Ability to work in a collaborative environment and build effective working relationships across the organization, and with external stakeholders/vendors - Detail and process orientated, with excellent project management, problem solving, and organization skills - Ability to think critically with strong attention to detail - Demonstrated project management and prioritization capabilities Qualifications - 4+ years’ experience in Drug Safety / Pharmacovigilance in a Biotech / Pharma company - 8+ years of industry (Biotech / Pharma) experience - Healthcare degree required / Medical Degree (MD) from recognized medical school preferred - Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines - Demonstrated experience with medical drug safety assessments, drug safety surveillance and monitoring activities - Proficiency with medical review of ICSRs, including expectedness assessments, causality assessments, narrative review and generation, generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment - Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment) - Experience with the medical review and preparation of aggregate reports (DSUR, PSUR/PBRER, PADER) - Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval - Experience with the development and updates to Reference Safety Information, including IB, Company Core Data Sheet (CCDS) and local labels - Ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders - Experience with MedDRA coding, Points to Consider, AoSE, and SMQs - Excellent verbal, written and presentation skills Benefits - Medical, dental, and vision insurance - 401(k) retirement savings plan - Generous paid time off (including a summer and winter company shutdown) - Comprehensive benefit package to support employees at each stage of their career, financial, health, and well-being journey Annual Salary Range $210,000 — $235,000 USD