Job Description
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 early-stage 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 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. Will 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. Responsibilities: Safety Signal Detection, Evaluation, and Management • Close collaboration with DSPV Safety Physicians to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates 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 • Contribute to signaling and data mining activities utilizing internal and external sources of data • Assist in the evaluation of potential safety issues and quality risk assessment reports. Risk Management and Safety Planning • Responsible for coordinating and developing Risk Management Plans for Nuvalent's products among multiple stakeholders • Responsible for patient safety evaluation and development of Safety Management Plans. Safety Governance, Meetings, and Reporting • Contribute to activities related to Nuvalent's safety (governance) meetings, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues • Manage and support the authoring for aggregate safety reports (e.g., DSUR, PBRER, PADER) in close collaboration with clinical, medical writing and operational functions Process, SOPs, and DSPV Ways of Working • Contributes to the development of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety. • Responsible for ensuring the global team can anticipate, develop and support improved/consistent scientific ways of working to implement effective PV processes Analytics and Tools • Establish expertise with data visualization tools (e.g., Spotfire) • Contribute as a member of the DSPV team to scenario planning, strategy analysis, portfolio prioritization, budget management and forecasting Leadership and Training • Provide management/mentoring of existing Safety Scientists and training for new staff on PV practices and therapeutic area knowledge Competencies: • 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: • Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD. • 9+ years' experience in Drug Safety/Pharmacovigilance in a pharmaceutical, biotech company or regulatory agency in similar positions • 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 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) r
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