Nuvalent, Inc.

Director

• 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 (ie. 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

Director, National Thought Leader Liaison

Manager

• 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.

Manager, Quality Computerized System Validation

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

• 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

Senior Manager, Contracts - Clinical

Compliance

• 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

Senior Manager, Regulatory Affairs

Supply Chain

• 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
• Ensures 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.

Associate Director, Supply Chain Logistics – Compliance

Operations

• 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.

Associate Director, Pharmacovigilance – PV Operations

Medical Director

• 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

Associate Medical Director, Drug Safety and Pharmacovigilance

Clinical Operations

• Lead and manage and provide strategic input on one or multiple clinical studies and demonstrate thorough knowledge of clinical operations’ project management. Lead cross-functional clinical study team to support clinical study delivery.
• Evaluates, selects, and ensures appropriate oversight of CROs and other external vendors.
• Ensures clinical trials are executed according to scope of work, budget, timelines, and KPIs.
• Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support corporate goals.
• Identify risks and propose solutions to facilitate clinical studies.
• Develop and demonstrates accountability for the management of study budgets through review and approval of contracts and/or work order changes; manages 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 the Clinical Data Manager to ensure timely and efficient database lock.
• Participate in data review and reconciliation efforts.
• Mentor junior team members by delegating study related responsibilities, overseeing, and supporting development plans.
• Lead or co-lead department initiatives to support an expanding organization.
• Travel may be required (10% – 15%).

Associate Director, Clinical Operations

• Reporting to the Associate Director, Corporate Strategy, supporting CI activities across Nuvalent's portfolio.
• Utilizing systematic processes to gather and summarize competitive information.
• Providing context and objective analysis of competitive information to enable actions and business decision-making.
• Building and updating databases on competitive landscape.
• Presenting key competitive information to teams and leadership throughout the organization.

Senior Manager, Competitive Intelligence

• Reporting to the Director, Patient Access Services, the Associate Director, Access & Reimbursement (ADAR) will be a critical member of the Market Access team to create patient impact by providing field access support and education to healthcare professionals (HCPs)
• Helps to maximize patient access to products
• This role will be an empowered and confident subject matter expert in supporting complex patient cases through understanding the payer landscape, customer engagement, and internal cross-functional collaboration
• Support the patient access strategy and operations, working closely with the Patient Support (PS) team on patient cases and program oversight
• Provides education to HCPs and their staff on payer-specific coverage criteria and documentation requirements to help address access and reimbursement barriers for prescriptions already in progress
• Delivers guidance on access support, including processes, forms, payer-related coverage challenges, and the Nuvalent patient financial support programs
• Proactively identify and help to resolve payer, account, and patient access barriers using data-driven insights, dashboards, and cross-functional collaboration
• Coordinate with specialty pharmacy, PS operations, payer, market access, medical affairs, and other cross-functional colleagues to support patient access
• Triage and resolve patient support related questions and access concerns escalated from field teams, ensuring timely and compliant resolution
• Educate and inform regional field facing teams on PS programs, geographical payer nuances, access challenge trends, and program insights
• Develop patient access and reimbursement strategies with cross-functional teams, while monitoring regulatory, payer & industry trends, to proactively & compliantly address access challenges
• Support oversight of patient support programs (financial assistance & non-commercial specialty pharmacy); ensuring accountability for positive customer impact & excellence

Associate Director, Access & Reimbursement

• 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%).

Director, National Thought Leader Liaison

Manager, Quality Computerized System Validation

Manager, GMP Quality Assurance

Senior Manager, Contracts - Clinical

Senior Manager, Regulatory Affairs

Associate Director, Supply Chain Logistics – Compliance

Associate Director, Pharmacovigilance – PV Operations

Associate Medical Director, Drug Safety and Pharmacovigilance

Manager, GMP Quality Assurance

Associate Director, Clinical Operations

Senior Manager, Competitive Intelligence

Associate Director, Access & Reimbursement

Manager, Clinical Operations