The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director, PV Operations will provide vendor oversight and review of ICSR processing for assigned investigational products. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be responsible for PV operations’ role in Phase 1, 2, & 3 clinical studies, inclusive of inspection readiness, reconciliation, SMP maintenance, and site and regulatory authority reporting oversight. They will work in close collaboration with PV physicians and PV scientists on operational safety and case quality issues.

Responsibilities:

• 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.
• Participate in daily management, operational oversight and execution of operational safety tasks for assigned Nuvalent clinical programs.
• 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
•  
• Responsible for the development of safety management plans for assigned programs, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow responsibilities between CROs, and Nuvalent are clearly delineated and adhered to

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in Nursing, RN, Pharmacy, Pharm D., or other relevant health-care related fields.
• 8-10 years of progressive drug safety experience in a biotech/pharma company.
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.
• Direct experience managing relationships with service providers or external business partners

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Head of Contracts, the Senior Manager, Contracts - Clinical will serve as the primary contracts professional working closely with the Clinical function, particularly Clinical Operations. This is a hands-on, high-volume role responsible for the full lifecycle of clinical site agreements and ancillary clinical contracts across Nuvalent’s global study portfolio, currently spanning four concurrent studies including a Phase 3 randomized controlled trial.

The ideal candidate has deep experience in global clinical site contracting at a sponsor company or CRO, is comfortable operating with significant autonomy, and has the judgment to know when to resolve an issue independently and when to escalate. This role works directly alongside a peer team of Senior Contracts Managers within a contracts department that is growing alongside Nuvalent’s pipeline.

Responsibilities:

Clinical Site & Study Agreements

• Draft, review, negotiate, and execute Clinical Trial Agreements (CTAs) with academic medical centers, community research sites, and international investigator sites across global markets.
• Manage the full contract lifecycle from initial draft through execution, amendment, and close-out across a high-volume, multi-study portfolio.
• Coordinate Informed Consent Form (ICF) review as needed in connection with site-level contracting.
• Negotiate and process Work Orders (WOs) and Change Orders (COs) in coordination with Clinical Operations and relevant CRO or vendor counterparties.
• Serve as the primary contracts point of contact for site administrators, legal counsel, and CRO contract teams, maintaining productive counterparty relationships through complex negotiations.

Ancillary Clinical Contracts

• Draft, review, and negotiate Confidential Disclosure Agreements (CDAs) and Non-Disclosure Agreements (NDAs) for clinical partnerships and site-level engagements.
• Manage consulting agreements for clinical investigators, key opinion leaders, and clinical consultants engaged by Clinical and Clinical Operations, with appropriate escalation of HCP engagements for compliance review.
• Support statements of work and related agreements for Clinical and Clinical Operations vendors.

Contract Operations & Process

• Maintain accurate, complete, and timely contract records in Nuvalent’s contract management system (Agiloft), including status updates, executed document storage, and obligation tracking.
• Apply and enforce departmental file naming conventions, version control standards, and repository management protocols.
• Provide timely contract status visibility to Clinical and Clinical Operations business owners and serve as a reliable point of contact for internal stakeholders throughout the contract lifecycle.
• Identify issues requiring escalation and engage appropriate internal resources — including Legal, QA, Regulatory, Clinical Operations, Finance, IT, and Compliance — or external resources including CRO counterparties, outside counsel, or the Data Privacy Officer (DPO).
• Contribute to negotiation playbooks, standard fallback positions, and contract templates for clinical contract types.
• Coordinate with Legal and the DPO on data privacy provisions in clinical agreements, including GDPR data processing terms for EU and international site agreements.
• Utilize AI-assisted contract review tools as integrated into departmental workflow in accordance with established Nuvalent guidance.
• Lead or co-lead department initiatives to support an expanding organization.

Competencies Include:

• Detail and process oriented, with strong organizational skills and the ability to manage a high-volume, multi-study contract portfolio across competing deadlines and shifting priorities.
• Strong negotiation, problem solving, and communication skills, with the ability to hold a position, find common ground, and close without unnecessary escalation.
• Flexibility with changing priorities and ability to think critically under pressure.
• Ability to work in a collaborative environment and build effective working relationships across the organization, including with external counterparties such as site administrators, CRO contract teams, and outside counsel.
• Sound judgment in recognizing when to resolve independently and when to bring in the right internal or external resources.
• Able to thrive in a remote/virtual environment.

Qualifications:

• Minimum of 7 years of contracts experience in the biopharmaceutical or clinical research industry, with at least 4 years focused on vendor agreements, clinical site agreements, investigator agreements, or study start-up contracting; sponsor-side experience preferred, CRO-side experience considered.
• Demonstrated experience negotiating CTAs, WOs, COs, CDAs, and HCP consulting agreements at volume across multiple concurrent studies.
• Direct experience contracting with international clinical sites and working knowledge of applicable legal and regulatory requirements including GDPR data processing considerations.
• Working knowledge of GCP, ICH guidelines, and FDA regulations governing clinical research and their practical implications for contract terms.
• Familiarity with IRB processes and their intersection with site-level contracting.
• Proficiency with contract lifecycle management systems; experience with Agiloft, Ironclad, DocuSign CLM, or comparable platforms required. Agiloft experience a plus; training will be provided.
• Oncology experience preferred; relevant experience from adjacent therapeutic areas will be considered.
• Familiarity with AI-assisted contract review tools a plus.
• Bachelor’s degree or equivalent experience required.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

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). This role provides operational leadership, discipline, and alignment across Medical Affairs, ensuring that objectives, processes, and resources are optimized to deliver impact at scale. The incumbent will drive operational excellence, enable cross-functional collaboration, and oversee field operations, insights, and analytics to support the organization’s growth and transformation.

Responsibilities:

• Strategic Partnership & Leadership
  • Act as a trusted advisor to the Head of Medical Affairs and MALT, shaping operational strategy and execution.
  • Drive strong cross-functional team planning and alignment (e.g. MALT, MALT/CLT, Medical Strategy, and IEGT), ensuring smooth ways of working and operational discipline, with seamless execution of strategic priorities.
• Performance Management and Launch Readiness
  • 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.
• Operational Excellence and Continuous Improvement
  • Define and evolve ways of working within Medical Affairs, including process development, capability building, and cross-functional orchestration.
  • Drive continuous process improvement and simplification, including SOP development and refinement to ensure scalability and compliance.
• Financial Stewardship
  • Oversee budget planning, forecasting, and resource allocation to ensure fiscal discipline and strategic investment.
  • Partner with Finance to align operational spend with organizational priorities.
• Risk Management & Executive Communications
  • 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.
• Strategic Initiatives and Capability Building
  • Support and enable key initiatives such as regional expansion, organizational transformation, and business model evolution.
  • Support Medical capability building initiatives, ensuring teams are equipped with the skills, processes, and tools to deliver impact.
• Knowledge & Communication
  • Establish central knowledge management systems to ensure accessibility and transparency of information.
  • Facilitate effective team communication and alignment across Medical Affairs and field teams.
• Field Operations & Analytics
  • Provide oversight of field operations, insights generation, and analytics to inform strategy and decision-making.
  • Ensure robust mechanisms for capturing and translating field intelligence into actionable insights.
• Team Facilitation & Culture
  • Foster a high-performance culture through facilitation, coaching, and team development.
  • Enable collaboration, accountability, and continuous learning across Medical Affairs.

Competencies Include:

• Strategic thinker with operational rigor.
• Collaborative leader who builds trust and alignment across diverse stakeholders.
• Skilled in change management and organizational transformation.
• Adept at balancing strategic priorities with tactical execution.
• Committed to fostering a culture of accountability, transparency, and innovation.

Qualifications:

• Advanced degree in life sciences, healthcare, or related field; MBA or equivalent preferred.
• 10+ years of experience in Medical Affairs, clinical development, or related operational leadership roles.
• Proven track record of leading cross-functional teams and driving operational excellence in complex organizations.
• Strong financial acumen with experience in budget management and forecasting.
• Expertise in KPI development, performance tracking, and analytics.
• Exceptional communication, facilitation, and stakeholder management skills.
• Ability to synthesize complexity into clear, actionable frameworks for executive and board-level audiences.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

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.

The Senior Manager, Regulatory Affairs will contribute to the development and implementation of regulatory strategy as a member of the global regulatory affairs function and clinical study team(s). This role will manage the process for preparation, submission and internal review and approval of regulatory documents, including providing technical regulatory input for global documents to streamline development.

The Senior Manager, Regulatory Affairs must be kept current, innovative, and compliant with the constant changing Health Authority requirements to facilitate regulatory processes and compliance maintenance from IND/CTAs through NDA/MAA. 

Responsibilities:

• Participates 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
• As part of the regulatory clinical study team, you will 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

Competencies Include:

• Excellent attention to detail and ability to complete efficient and detailed technical data review
• Excellent organization, communication, and multi-tasking skills
• Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships
• Strong desire to contribute as a member of an engaged and collaborative cross-functional project development team

 Qualifications:

• 6-8 years of experience in Regulatory Affairs or combination of education and direct experience.
• Bachelor or advanced degree in a scientific field or equivalent work experience is required.  Master’s degree a plus.
• Proven experience in evaluation, preparation and compilation of quality dossiers in all required formats and/or experience in regulatory processes.
• Solid understanding of the e-CTD specifications for electronic submissions.
• Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD and CDER requirements for the drug approval process.
• Previous participation in preparing and/or leading regulatory submissions (IND, CTA, NDA, etc.). Experience with preparing meeting packages is a plus.
• Experience in interpretation of regulations, guidelines and precedents related to drug development in the US and EU.
• Strong understanding of regulatory eCTD structure and clinical trial conduct and design
• Proficiency with electronic submission publishing software and document management information systems (i.e., docuBridge, Veeva Vault RIM)
• Ability to plan, prioritize and contribute to work and projects in a systematic and efficient manner with emphasis on streamlining processes

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Senior Director of Pharmacovigilance (PV) Operations, the Associate Director of PV Operations will provide vendor oversight and review of ICSR processing. They will ensure compliance and adherence to Safety processes and SOPs as well as manage and analyze data from the Global Safety Database. This SME will be the primary point of contact for quality oversight of the case processing vendor. They will work in close collaboration with PV physicians, PV scientists, and PV Excellence on operational safety and case quality issues The role will expand and evolve in line with Nuvalent’s expansion as we approach potential market authorization.

Responsibilities:

• 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.

Competencies Include:

• Excellent written and verbal communication skills.
• Demonstrated communications expertise with the ability to articulate, influence, and work successfully with internal/external stakeholders and within a matrixed environment.
• Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
• Demonstrated contribution to strategy and innovation. Contributes to or leads actionable strategies.
• Demonstrated project management and prioritization capabilities.

Qualifications:

• Bachelor’s degree in nursing, RN, Pharmacy, Pharm D., or other relevant health-care related field.
• 8-10 years of experience in a biotech/pharma company.
• Direct experience managing relationships with service providers or external business partners
• Clinical Development experience.
• Strong knowledge of current and emerging regulatory requirements including EMA GVP Modules, FDA IND and NDA reporting requirements, ICH, CIOMS
• Ability to interpret and follow regulatory guidelines.
• Proven knowledge of Good Documentation Practices and cGXPs.
• Basic knowledge of MedDRA coding.
• Experience in ICSR case-processing and reporting.
• Experience working in and with safety databases.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

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 who thrives 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
• 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
• Understands 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.

Competencies:

• Effective communicator with strong stakeholder management
• Detail-oriented with a strong compliance mindset
• Encourages collaboration, innovation and new ideas while integrating information from various sources. 
• Demonstrated ability to develop and foster relationships with internal and external stakeholders.   
• Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
• Excellent problem solving, communication and organization skills.

Qualifications:

• Education Required: 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

 Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

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

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Head of PV Science, the Associate Director, Drug Safety and Pharmacovigilance Scientist is 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, PADERs, PBRERs, and clinical safety assessments). This individual may also support the medical assessment of Individual Case Safety Reports (ICSRs) and other drug safety information. 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:

• 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 processes, 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 of 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 the medical assessment of ICSRs as needed
• Support other pharmacovigilance and drug safety responsibilities as assigned

Competencies Include:

• Design global risk management frameworks for Nuvalent’s medicines
• Translate safety data into clinical insights
• Adapt visualization tools for safety surveillance
• Influence multidisciplinary teams to prioritize patient safety.
• Strong ability to build relationships, collaborate and influence across disciplines within Nuvalent and with outside stakeholders

Qualifications:

• 4+ years’ experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• 7+ years of Pharma / CRO experience. 
• Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
• Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• Experience with medical drug safety assessments, drug safety surveillance and monitoring activities
• Experience with safety data collection and interpretation from clinical trials, literature and post market
• Experience with preparation of responses to Regulatory Authorities and 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, IB, Company Core Data Sheet and local labels
• Excellent verbal, written and presentation skills

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Associate Director, Clinical Operations, the Sr. Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. You will be working on a clinical study with responsibilities including site selection, contract negotiation, budget management, study start-up, conduct and close-out.  This role will collaborate with cross-functional study team as well as demonstrate excellent management of and partnership with CROs and vendors. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharmaceutical company and delivering high quality clinical trial results.  

Responsibilities:

• 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.
• Travel may be required (10% – 15%).

Competencies Include:

• Detail and process orientated, with excellent project management skills, including risk assessment and contingency planning.
• Excellent problem solving, communication and organization skills.
• Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
• Ability to work in a collaborative environment and build effective working relationships across the organization.
• Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously.

 Qualifications:

• At least 5 - 7 years of Clinical Operations experience.
• Bachelor’s degree or higher in a scientific or healthcare discipline preferred and relevant experience within the biotech, pharmaceutical, or CRO industry.
• Extensive knowledge of current ICH-GCP guidelines.
• Relevant experience managing early through late Phase clinical trials.
• Demonstrated cross-functional leadership fostering team spirit and team motivation.
• Capability to challenge status-quo using risk management approach.
• Able to thrive in a remote/virtual environment.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Associate Director, Formulation Sciences, the Senior Manager, Formulation Sciences will act as late-stage drug product subject matter expert and will support drug product process validation toward commercialization. The successful candidate needs to demonstrate a proven record of working in a virtual environment with CDMOs to deliver clinical and commercial supplies in support of fast-paced late-stage development programs. Using strategic thinking, the Senior Manager must be able to develop and execute process validation strategies for successful product commercialization.

This individual has responsibility for support of drug product process validation, scale up, and post-approval changes (SUPAC) and routine commercial manufacturing activities across Nuvalent’s contract research and manufacturing organizations. The primary accountability is being the steward for product development and manufacturing as these programs transition through development and into commercialization. The ultimate goal will be to ensure robust process and manufacture strategies for consistent commercial supply.

Responsibilities:

• 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.

Competencies:

• Strong organizational, planning, and multitasking skills in a fast‑paced environment.
• Excellent relationship‑building and communication skills across diverse teams.
• Evidence of effective cross‑functional collaboration with both internal teams and external partners.
• Strong problem‑solving and analytical skills with the ability to break down complex issues.
• Results‑driven mindset with attention to quality and timelines. A strong understanding and knowledge of cGMP/ICH regulations and an ability to apply them to drug product development and manufacturing is required.
• Excellent organization and multi-tasking skills.
• Experience building positive and effective cross functional relationships and the ability to align stakeholders, both internally and externally to Nuvalent.

 Qualifications:

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering or related field with a minimum of 3+ years or MS with 6+ years /BS with 10+ years of industry experience.
• Proven track record on drug product process validation, scale up and manufacture for solid dosage form (tablets).
• Experience with QbD principles and DOE methodology preferred.
• Manage the outsourcing manufacturing activities at CDMO sites to meet CMC goals.
• Understanding of cGMP/ICH guidelines and the ability to apply them to development and manufacturing.

• Experience with solid dosage form (tablet) process development; exposure to late-stage validation is a plus.

• Ability to author and critically review relevant development reports as well as regulatory dossiers.
• Up to 25% travel is expected, both domestically and internationally.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

Reporting to the Vice President, Information Technology, the Director, IT Business Partner, GXP will serve as a strategic technology leader responsible for aligning IT capabilities with business objectives across all GXP-regulated departments (GMP, GLP, GCP) as the organization prepares for commercial launch. This role requires deep expertise in pharmaceutical IT systems, regulatory compliance, and the ability to translate complex business requirements into scalable technology solutions that support quality, compliance, and operational excellence.

Responsibilities:

• 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

Competencies:

• Deep understanding of GXP regulations and their application to IT systems
• Strong knowledge of pharmaceutical manufacturing, quality, and clinical operations
• Experience with GAMP 5, industry standards, and cloud technologies in regulated environments
• Exceptional stakeholder management and communication skills across all organizational levels
• Strategic thinker with strong business acumen and ability to deliver complex projects on time and budget
• Experience in leveraging Enterprise Architecture to deliver business value

 Qualifications:

• Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or related field required
• 10+ years of progressive IT experience in pharmaceutical, biotechnology, or regulated healthcare manufacturing environments
• 5+ years in a leadership role managing IT business partnerships, systems implementations, or GXP IT operations
• Demonstrated experience supporting commercial launch activities or significant operational scale-up in a pharmaceutical setting
• Proven track record implementing and managing multiple GXP-regulated systems, especially Veeva systems
• Hands-on experience with Computer System Validation (CSV) and regulatory compliance requirements (21 CFR Part 11, EU Annex 11, data integrity)
• Experience managing IT budgets, vendor relationships, and cross-functional projects
• PMP, ITIL, or relevant IT certifications
• Knowledge of serialization, track-and-trace, and emerging technologies (AI/ML, analytics)

 Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

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, to ensure our upcoming product launches in ROS1 NSCLC and ALK+ NSCLC are strategically positioned to achieve payer coverage, organized customer access, and patient access. This role will be responsible for payer marketing, organized customer marketing, patient support services marketing, and creating market access initiatives to optimize coverage, adoption, and reimbursement of our novel therapies. Given the cross-functional nature of the role, the market access marketer will have a dotted reporting line to the Vice President, Marketing. S/he will also collaborate closely with Sales, HEOR, and Medical Affairs to drive launch readiness and post-launch success.

Responsibilities:

Strategic Planning

• Payer & Health Care Decision Maker (HCDM) Messaging Strategy – Develop compelling value propositions and messaging highlighting clinical benefits, cost-effectiveness and differentiation.
• Agency Management – Manage market access marketing AOR to refine and implement strategy, messaging, and materials.
• Work with cross-functional teams to inform and execute pricing, reimbursement and access strategies aligned with business objectives.
• Identify and capitalize on strategic opportunities to best position Nuvalent products at National Accounts (e.g., GPOs, Physician Networks, National and Regional Payers, Pathways and Strategic Partners), including overseeing the execution of marketing tactics at annual meetings

 Market Access & Payer Engagement Support

• Develop Market Access Materials – Create tailored account director presentations, digital content and key messaging to deliver to payer and provider HCDMs.
• Pre-Approval Information Exchange (PIE) – Refine and implement PIE strategy, messaging and materials to effectively meet payer expectations and regulatory guidelines.
• Value Proposition – Craft evidence-based messaging to support differentiation story, formulary inclusion, pathway placement, and EHR integration.
• FAQs & Reimbursement Guide – Prepare pricing, coding and coverage documents addressing payer concerns.
• Distribution Selling Sheets – Equip distribution partners with materials on product availability and logistics.

 Integrated Delivery Network, GPO Engagement, & Patient Services Support

• Access Materials for GPO and IDN HCDMs – Educate healthcare professionals on reimbursement and formulary details.
• Patient Support Programs – Develop resources for PSP including patient services website, financial assistance and copay support.
• Patient Access Content and Materials – Ensure patients have clear coverage, affordability, and access guidance.

 Internal Training & Strategic Insights

• Training Materials for Market Access Account Director teams – Create and execute training plans for teams to effectively utilize market access marketing materials
• Training Materials for Sales – Provide customized formulary status updates, access and reimbursement guides for sales team
• External Access Communications – Updating external stakeholders on formulary status and changes
• Stakeholder Insights – Organize Payer & Provider Advisory Boards for market insights.
• Competitive & HEOR Analysis – Incorporate relevant HEOR into value messaging and monitor pricing, access strategies and cost-effectiveness data to incorporate.
• Regulatory & Compliance Oversight – Ensure all materials meet FDA, CMS, and payer regulations.

 Competencies Include:

• Entrepreneurial mindset, and a successful track record working in a fast-paced, rapid-growth environment.
• Proven ability to manage multiple projects, identify and address needs, build internal capabilities and deliver results.
• Excellent interpersonal skills, with the ability to gain alignment by working collaboratively and inclusively across corporate functions.
• Strong verbal and written communication skills.
• Strong analytical skills and ability to translate data into actionable insights.
• Record of achievement, innovation, and compliance.

Qualifications:

• Bachelor’s degree required; advanced degree (MBA, PharmD, or PhD) preferred.
• 10+ years of experience in biotechnology, pharmaceuticals, or healthcare with a focus on market access marketing, or payer/organized customer/reimbursement strategy.
• Experience developing market access marketing strategies and executing tactics
• Product launch experience, preferably including oral oncology therapies
• Experience collaborating with external stakeholders to gather and incorporate insights.
• Deep understanding of payer and reimbursement landscape, including Medicare, Medicaid, and Commercial insurers.

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role

The Senior Director, DMPK will serve as the company’s key expert overseeing DMPK strategy across the entire company, including late-stage discovery, development, NDA submission, and commercial readiness, as well as designing, implementing, and interpreting DMPK studies, ensuring high-quality data and regulatory-ready documentation to support IND, CTA, and NDA filings.

As part of a growing biotech organization, the role requires a hands-on, collaborative leader who can build and guide a high-performing team while working cross-functionally to advance a dynamic portfolio.

This is a pivotal leadership role in a fast‑growing biotech preparing for its first commercial launch.

Responsibilities

• 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).

Study Design & Execution

• 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.

Regulatory and Documentation

• 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.

 Competencies

• Demonstrated ability to collaborate across matrixed, cross-functional teams in a fast-paced environment.
• Proven ability to manage multiple projects simultaneously with attention to timelines and detail.
• Strong communication and interpersonal skills; build trust and foster relationships internally and externally.
• Able to work independently, take initiative, and adapt quickly to evolving priorities.
• Recognized leader who exhibits effective communication, emotional intelligence, and influencing skills, within a matrix operating environment.
• Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
• Ability to effectively manage multiple projects with competing priorities.

Qualifications

• 12+ years of industry experience in DMPK, including leadership responsibility.
• D. in Pharmaceutical Sciences, Pharmacokinetics, Biochemistry, Chemistry, or related discipline; postdoctoral training preferred.
• Proven track record supporting programs from discovery through clinical development; experience with IND and NDA/MAA submissions strongly preferred.
• Demonstrated experience supporting small‑molecule oncology therapeutics, ideally kinase inhibitors or targeted therapies.
• Hands‑on expertise with ADME assays and mechanistic metabolism studies and PK/PD modeling and simulation, proficient in Phoenix WinNonlin, preferred: experience with GastroPlus modeling.
• Experience contributing to late‑stage development and NDA filings, preferably in oncology.
• Prior experience supporting products approaching commercial launch.
• Experience with vendor/CRO oversight and budget management.
• Experience working in a small/mid-size biotech environment preferred (rapid decision-making, cross-functional collaboration, matrix leadership).

Additional Information

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.

The Role:

The Senior Director, Clinical Pharmacology will lead Nuvalent’s clinical pharmacology strategy across all development programs, including late‑stage registrational efforts and emerging early‑phase assets. This leader will guide dose optimization, exposure–response modeling, regulatory strategy, and clinical pharmacology components of NDA submissions.  

Responsibilities:

• 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.

 Competencies:

• Demonstrated ability to collaborate across matrixed, cross-functional teams in a fast-paced environment.
• Proven ability to manage multiple projects simultaneously with attention to timelines and detail.
• Strong communication and interpersonal skills; build trust and foster relationships internally and externally.
• Able to work independently, take initiative, and adapt quickly to evolving priorities.
• Recognized leader who exhibits effective communication, emotional intelligence, and influencing skills, within a matrix operating environment.
• Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
• Ability to effectively manage multiple projects with competing priorities.

  Qualifications:

• D., Pharm.D., or M.D. with specialization in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
• 12+ years of experience in clinical pharmacology within biopharma, including leadership in oncology or small‑molecule drug development.
• Proven track record supporting registrational‑stage programs and authoring components of regulatory submissions (INDs, NDAs/MAAs).
• Prior work with kinase inhibitors, and oncology therapies strongly preferred.
• Familiarity with late‑phase trial design and commercial launch preparation.

 Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages.

The targeted salary range below reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors.  The range will be reviewed regularly and is subject to change.

Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more

The Role:

Reporting to the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations.

This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs.

Responsibilities:

• Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
• Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
• Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
• Partner with or oversee CROs or Programming vendors to perform the tasks described above.
• Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
• Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.
• Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).

Competencies Include:

•  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.
• Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
• Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
• Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.
• Organizational and results orientation – Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

 Qualifications:

• Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field.
• 8+ years of (SAS) statistical programming experience in a clinical trial setting (industry/CRO).
• Advanced SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures.
• Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards.
• In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.
• Familiar with regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics and data handling in clinical development setting, and advanced knowledge of submission requirements and standards.
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
• Advanced understanding of statistical concepts in support of clinical data analysis.
• Advanced knowledge of programming standards and processes.
• Oncology experience is required.
• Skilled at performing quality control checks of SAS code and outputs produced by other Statistical Programmers.