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Nuvalent Inc

7 open roles indexed with location, benefit, and apply-link signals where available.

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  • Director, National Thought Leader Liaison

    Cambridge, MA / Remote

    remote $216K-$252K

    Director, National Thought Leader Liaison Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Thought Leader Strategy & Partnerships, the Director, Thought Leader Liaison will be a pivotal partner in Nuvalent's growing Commercial organization. This individual will spearhead the execution of the thought leader engagement as the company prepares for the market launch of Zidesamtinib and Neladalkib. The Director will be a pivotal member of the Commercial and Marketing teams. This role will provide guidance on thought leader relationships and partnerships ensuring alignment with brand objectives and coordinating end to end relationships for the Commercial organization. This individual will also support the execution of brand strategies to ensure launch readiness. Responsibilities: - Develop and execute a comprehensive Commercial engagement strategy for lung cancer thought leaders, including academic researchers, digital opinion leaders, and other key influencers. - Collaborate with internal teams to implement commercial strategies and manage interactions with key accounts, ensuring alignment with Nuvalent's business goals. - Capture valuable therapeutic and competitive insights from Thought Leaders and other key stakeholders to guide impactful field insights integration that shapes positioning, messaging, and stakeholder engagement strategies - Work closely with the Senior Director, Thought Leader Strategy to aggregate

  • Senior Scientist, Analytical Sciences

    Cambridge, MA / Remote

    remote $140K-$160K

    Senior Scientist, Analytical Sciences Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Analytical Sciences, the Senior Scientist, Analytical Sciences, has responsibility for the analytical aspects of drug product development and manufacturing activities across the relevant Nuvalent CRO and CDMOs. The candidate will interface with the program's Quality Control, Drug Product, Quality Assurance, CMC Project Manager and Regulatory CMC functional representatives. Responsibilities include ensuring that drug product analytical support is timely, high quality, and consistent with the Phase-Appropriate strategy outlined by the project team and CMC Team. The candidate will support analytical activities for a clinical small molecule oncology program. This role would entail internal and external facing responsibilities as a member of the analytical sciences group on the cross-functional CMC team and through analytical leadership of key external CRO/CDMO relationships. The successful candidate needs to demonstrate a proven track record of working with CROs/CDMOs to support drug product development through the delivery of high-quality analytical methods, process support, and stability studies. The ability to thrive in a virtual environment in support of developing and delivering drug product for fast-paced clinical development programs will be critical. In addition, using strong technical analytical experience and effective knowledge

  • Senior Manager, Regulatory Affairs

    Cambridge, MA / Remote

    remote $160K-$185K

    Senior Manager, Regulatory Affairs Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 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

  • Associate Medical Director, Drug Safety and Pharmacovigilance (PV)

    Cambridge, MA / Remote

    remote $210K-$235K

    Associate Medical Director, Drug Safety and Pharmacovigilance (PV) Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 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

  • Director, Market Access Marketing

    Cambridge, MA / Remote

    remote $215K-$245K

    Director, Market Access Marketing Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 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

  • Senior Director, Clinical Pharmacology

    Cambridge, MA / Remote

    remote $270K-$295K

    Senior Director, Clinical Pharmacology Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 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

  • Senior Director, Drug Metabolism and Pharmacokinetics (DMPK)

    Cambridge, MA / Remote

    remote $270K-$295K

    Senior Director, Drug Metabolism and Pharmacokinetics (DMPK) Cambridge, MA / Remote The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 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