Nuvalent, Inc.

Security Operations

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

Manager, IT Security Operations

Director

• Support development and execution of annual Medical Affairs strategic and tactical plans.
• Collaborate cross-functionally with Clinical, Commercial, Regulatory, and Field Medical to ensure alignment with scientific and business objectives.
• Operationalize and manage Medical Affairs activities such as advisory boards, symposia, scientific congress planning, and educational initiatives.
• Serve as a key Medical Affairs contributor on the Promotional Review Committee (PRC) and Medical Review Committee (MRC) to ensure scientific accuracy, compliance, and alignment with medical strategy.
• Support the planning and implementation of the Investigator-Sponsored Research (ISR) program, including proposal review, coordination of internal evaluations, and communication with investigators.
• Partner with Clinical Development to integrate healthcare provider insights and support the design and execution of clinical trials.
• Collaborate with Commercial colleagues on compliant alignment of strategy and assist with development of promotional materials including slide decks, FAQs, and internal training content.
• Help develop and maintain internal Medical Affairs processes, SOPs, and guidance documents.
• Gather, synthesize, and share scientific and clinical insights from KOL interactions, advisory boards, and scientific conferences.
• Assist in vendor oversight and budget management for assigned initiatives.

Director, Medical Affairs Strategy

Operations

• Lead day-to-day Medical Affairs operations, ensuring smooth execution across programs and initiatives.
• Streamline processes and enable efficient ways of working across Medical Affairs.
• Manage contracts, purchase orders, invoicing, bills, and financial tracking.
• Deliver financial reporting versus plan, ensuring transparency and accountability.
• Manage advisory board planning, contracts, and operational execution.
• Lead medical congress planning and execution including booth and tabletop logistics, KOL engagement, and cross-functional coordination.
• Coordinate for the Grants Review Committee, managing intake of CME and non-CME medical education grant requests.
• Oversee payments and operational processes for investigator-sponsored trials.
• Maintain document repositories, version control, and archiving processes to support compliance and operational efficiency.

Manager, Medical Affairs Operations

Compliance

• Reporting to the VP, US Regulatory Advertising & Promotional Labeling, represent Regulatory in the review and approval of prelaunch and post launch promotional activities for U.S. marketed products.
• Contributes to the development and implementation of promotional review strategies.
• Builds and maintains relationships with cross functional representatives of the Promotional Material Review Committee (PMRC).
• Assist in identifying areas of promotional risk and mitigation strategies.
• Serves as Regulatory representative in the Medical Review Committee (MRC) in the review and approval of compliant scientific materials.
• Provides regulatory advice for compliant advertising and promotional materials for launch, marketed and development products.

Associate Director, Regulatory Advertising and Promotional Labeling

• Reporting to the Vice President, Accounting, lead and serve as a key advisor for all tax and treasury matters for the company.
• Responsible for developing and implementing strategic tax planning and leading all aspects of the company’s tax function.
• Collaborate closely with cross-functional stakeholders, including Accounting, FP&A, Legal, Supply Chain, and external tax advisors and auditors.
• Serve as a strategic advisor to leadership on tax implications of business decisions.

Senior Director, Tax and Treasury

• Act as main point of contact for CDMOs during late-stage production of regulatory starting materials
• Champion deliberate, mindful execution of scale up and technology transfers
• Work within a cross-functional team on assigned projects to define or refine a phase-appropriate control strategy, including the identification and justification of critical material attributes, critical equipment attributes, and critical process parameters
• Use engineering principles and risk management methodologies to evaluate experimental data or manufacturing performance and identify opportunities for process optimization and improvement throughout the product lifecycle
• Troubleshoot production issues and work in cross functional teams to implement effective and persistent corrective/preventative measures
• Author, review, and/or edit key CMC and quality deliverables, including (but not limited to): campaign reports, PPQ protocols and reports, tech transfer reports, master batch records, deviation reports, control strategy summaries
• Support Reg CMC by reviewing or authoring drug substance sections of various filings, or by supporting Nuvalent responses to health authority questions
• Communicate effectively with technical and non-technical stakeholders as required to keep teams abreast of progress, deliveries, timelines, or potential risks thereto
• Commit to cGMP principles and Nuvalent’s quality system, and maintain the utmost concern for the health of our patients

Associate Director, Chemical Development

• 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

Human Resources

• Partner with business leaders in areas such as change management, organizational assessment & structure, leadership planning, and workforce planning to strengthen the overall organizational capability of the team.
• Ensure alignment of HR processes i.e. Performance Management and Development, Monthly & Quarterly Business Reviews (Sales QBR’s), etc. with strategic and operating goals.
• Advise and counsel employees and managers in areas such as organizational development, talent and career development, performance management, compensation, coaching, employee engagement and retention, resource planning, recognition programs, etc.
• Ensure effective talent management including recruitment, assessment, and development as the organization grows.
• Assist managers in assessing and identifying resources to meet employee/departmental training needs and support employees to continuously develop their skills in partnership with Commercial Training.
• Manage the partnership with the talent acquisition team, including staffing coordination and job requisition management.
• Partner and lead the annual performance management and compensation planning processes including variable pay and recognition programs.
• Build deep and impactful partnerships with the HR specialist functions such as Total Rewards, Talent Acquisition, Learning and Development and Talent Management to provide HR solutions to key business needs and to roll out corporate-wide programs that enhance the overall employee experience and support growth and success of overall business strategy
• Lead all aspects of relevant US and state employment laws and other human resources compliance issues for field employees.
• In partnership with the HR team, interpret and implement HR policies, procedures, programs and initiatives across the organization; recommend continual improvements as needed
• Develop dashboards to assess and communicate HR goals' performance for continuous improvement
• Proactively defines, builds and implements value-added HR strategies and solutions

Director, Human Resources Business Partner

• Reporting to the SVP, Drug Safety and Pharmacovigilance, the Senior Director is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products.
• Oversee risk management plan activities including signal tracking maintenance, ad hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Nuvalent’s products.
• Close collaboration with DSPV Safety Physicians to analyze potential safety issues, including signal detection, signal evaluation and signal management.
• Collaborate proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• Assist in the evaluation of potential safety issues and quality risk assessment reports.
• Coordinate and develop Risk Management Plans for Nuvalent’s products among multiple stakeholders.
• Manage and support the authoring for aggregate safety reports (e.g., DSUR, PBRER, PADER) in close collaboration with clinical, medical writing and operational functions.

Senior Director, Head of Safety Science – Pharmacovigilance

Manager

• Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations
• Determine if promotional messages and medical statements are appropriately supported by data
• Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking
• Remain current on regulations and best practices within the industry
• Maintain ongoing communication with Medical Leads to ensure materials are aligned to medical strategy
• Demonstrate knowledge of disease area, product labeling, and regulatory guidance
• Maintain therapeutic area and product knowledge through ongoing assessment of relevant literature, treatment guidelines, and internal and external data sources
• Conduct literature searches in order to ensure that the most current and appropriate literature is cited in the materials
• Support the development and updates of Medical Information Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), and other Medical Information materials in order to ensure complete, accurate, balanced, and referenced materials are available to respond to unsolicited requests for scientific information in a timely manner
• Support the development and updates of scientific Medical Affairs materials (e.g., decks, clinical trial flyers, medical exhibit materials, etc.)
• Support the development of regulatory compliance processes, including training documents, standard operating procedures, work instructions and other supporting process documents
• Support completion of quality review of medical information cases and, as necessary, ensure correction and provide feedback/retraining
• Support handling of inquiries escalated to the internal Medical Information department by providing timely responses to unsolicited inquiries
• Assist in recognizing, collecting, and ensuring the appropriate forwarding of safety/adverse event and/or product quality information according to FDA guidelines and company policies
• Attend external medical conferences and staff the Medical Affairs booth as needed

Senior Manager, Medical Information

General Counsel

• Reporting to the Deputy General Counsel, Commercial, advise on strategic and tactical issues related to prescription drug products
• Serve as a legal advisor on commercialization-related subjects to the cross functional brand team
• review committee member for advertising, promotional and non-promotional materials
• provide legal advisement on sales and marketing strategy, market access activities, and patient support programs
• assist in the development of the enterprise-wide compliance program

Senior Counsel, Commercial

• 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).

Associate Director, Statistical Programming

• Provides education to HCPs on payer-specific coverage criteria
• Identify and help to resolve payer, account, and patient access barriers
• Develop patient access and reimbursement strategies with cross-functional teams
• Support oversight of patient support programs

Associate Director, Access & Reimbursement

Financial Planning and Analysis

• Partner closely with Finance & various business teams to provide effective planning and analysis; provide senior leadership & business partners with appropriate tools and analysis to establish goals and measure performance
• Manage budgeting, forecasting, and planning initiatives throughout the company, including monthly, quarterly, and annual financial reporting packages and budget to actual analysis
• Lead the design, build & implementation of internal performance management reporting us BI tools to ensure appropriate level of visibility to OPEX, headcount, purchase orders etc. Assessment of key stakeholder needs, training & change management is within the scope of this role
• Participate in the development and implementation of new processes to support the successful completion of timely and accurate forecasts and tracking of key investments and performance metrics
• Maintain Nuvalent’s financial planning systems, models & reporting to ensure they are both accurate and updated to reflect latest assumptions and changing business needs
• Contribute to the accounting monthly close process. Collaborate with cross-functional teams to meet monthly close timeline while adhering to internal controls
• Provide support to the department leaders across the organization, to increase transparency around key financial results and assumptions, including spending controls/limits and forecasting
• Provide input to presentations for the leadership team and the board of directors
• Ad-hoc financial projects as assigned

Associate Director, Financial Planning and Analysis – FP&A

• Lead the U.S. & Global HEOR strategy and integrated evidence planning for Nuvalent assets.
• Standardize and optimize data generation policies, processes, and SOPs.
• Develop the annual HEOR tactical plan and budget; manage timelines, vendors, and scope.
• Educate and upskill teams on HEOR, evidence-based medicine, U.S. reimbursement trends, and Global HTA dynamics.
• Design, lead, and complete HEOR/RWE studies (e.g., observational studies, claims/EMR/registry analyses).
• Lead development of AMCP/Global dossiers, Budget Impact Models (BIMs), Cost-Effectiveness Analyses (CEA).
• Engage payers, IDNs, PBMs, specialty pharmacies, and other decision makers via compliant scientific exchange.