Lead the execution of thought leader engagement strategies to support the market launch of Zidesamtinib and Neladalkib. Coordinate relationships with academic researchers and influencers to integrate therapeutic insights into brand positioning and messaging.
Nuvalent, Inc.
15 Remote Job Openings at Nuvalent, Inc.
Manage the analytical Reference Material & Reference Standards (RMRS) program to ensure compliance with global cGxP standards. Lead the lifecycle management, qualification, and QC review of materials while coordinating with CMOs and cross-functional CMC teams.
Lead drug product analytical method development and validation for clinical oncology programs while managing external CRO and CDMO relationships. Oversee routine analytical activities, stability studies, and author technical regulatory submission documents.
Manager, Quality Computerized System Validation (CSV)
Nuvalent, Inc.
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Full Time
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16 days ago
Nuvalent, Inc.
Responsible for maintaining the validation lifecycle of GxP-regulated computerized systems across the organization. This includes developing CSV policies, managing system implementations, and acting as the subject matter expert during regulatory inspections.
The Manager of Clinical Operations ensures excellence in clinical trial planning, execution, and data collection in accordance with regulatory guidelines. They are responsible for site selection, study start-up, CRO oversight, and managing TMF activities.
Associate Director, Pharmacovigilance (PV) Operations (CT Focus)
Nuvalent, Inc.
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Full Time
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a month ago
Nuvalent, Inc.
The role involves providing vendor oversight and reviewing ICSR processing for investigational products to ensure compliance with safety processes and SOPs. The Associate Director will manage safety reporting for Phase 1-3 clinical studies and collaborate with PV physicians on case quality and operational safety.
The role involves developing and implementing global regulatory strategies and managing the preparation and submission of regulatory documents from IND/CTA through NDA/MAA. It also requires coordinating cross-functional teams and maintaining compliance with Health Authority requirements and internal SOPs.
Associate Director, Pharmacovigilance (PV) Operations
Nuvalent, Inc.
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Full Time
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a month ago
Nuvalent, Inc.
The Associate Director will oversee safety vendors, manage ICSR processing, and ensure compliance with global safety regulations and internal SOPs. They will also serve as a subject matter expert, collaborating with cross-functional teams to monitor safety metrics and facilitate clinical program safety reporting.
Associate Director, Supply Chain Logistics & Compliance
Nuvalent, Inc.
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Full Time
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a month ago
Nuvalent, Inc.
The Associate Director will lead global import/export activities, trade compliance, and the design of distribution networks to ensure efficient cross-border movement of goods. They will also partner with quality and regulatory teams to maintain audit readiness and adherence to cGMP and GDP standards.
Associate Medical Director, Drug Safety and Pharmacovigilance (PV)
Nuvalent, Inc.
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Full Time
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a month ago
Nuvalent, Inc.
The Associate Medical Director is responsible for the medical assessment of Individual Case Safety Reports and the interpretation of safety data from clinical trials and other sources. They will contribute to aggregate safety reports, signal detection, and provide medical expertise for clinical trial protocols and regulatory documents.
The Senior Manager of Clinical Operations will oversee clinical trial planning, execution, and data collection while managing CROs and external vendors. They are responsible for budget oversight, study start-up, and ensuring compliance with regulatory guidelines and corporate goals.
This role is essential for executing the Market Access strategy, focusing on Payer, Pricing, and Patient Support Services to ensure strategic positioning for upcoming product launches in ROS1 NSCLC and ALK+ NSCLC to achieve coverage and access. Responsibilities include developing payer marketing, managing organized customer marketing, creating patient support services marketing, and implementing initiatives to optimize coverage, adoption, and reimbursement of novel therapies.
Associate Director, Drug Safety and Pharmacovigilance Scientist
Nuvalent, Inc.
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Full Time
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2 months ago
Nuvalent, Inc.
The Associate Director is responsible for assessing and interpreting safety data from various sources, including clinical trials and spontaneous reports, and providing input for generating required safety reports like DSURs and PADERs. This role involves contributing to signaling processes, serving as a medical resource for clinical documents, and developing Risk Management Plans.
The Senior Director will lead the clinical pharmacology strategy across all development programs, guiding dose optimization, modeling, regulatory strategy, and clinical pharmacology components for submissions. Responsibilities include designing and leading clinical pharmacology studies, integrating PK/PD/safety/efficacy data, and representing clinical pharmacology in regulatory interactions.
Associate Director, Statistical Programming
Nuvalent, Inc.
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Full Time
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4 months ago
Nuvalent, Inc.
The Associate Director, Statistical Programming will lead programming efforts to produce and validate statistical outputs for regulatory and publication requests. They will also collaborate with various departments to ensure the accuracy of clinical trial data and analyses.