Senior Medical Director, Clinical Development

Summary

Join Nuvalent, a rapidly growing biotechnology company focused on oncology drug development, as a Senior Medical Director, Clinical Development. Reporting to the VP of Clinical Development, you will provide medical leadership and oversight for clinical studies, ensuring regulatory compliance and approval. This role involves hands-on participation in clinical trials, collaboration with a multidisciplinary team, and interaction with key stakeholders. You will be responsible for medical monitoring, data analysis, and the preparation of key regulatory documents. The ideal candidate possesses extensive experience in oncology clinical development, a strong understanding of the drug development process, and excellent communication skills. This position offers the opportunity to make a significant impact in the field of oncology.

Requirements

• An M.D. or M.D/Ph.D. with experience in oncology is required
• 4+ years of proven ability in the biotechnology or pharmaceutical industry including direct experience leading high functioning teams
• Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance
• Experience in clinical research, including designing, planning and monitoring clinical trials
• Ability to travel domestically and internationally to investigator sites and medical meetings, approximately 10%

Responsibilities

• Hands-on involvement in clinical studies that will support regulatory approvals
• Be the clinical lead for clinical trials, including performing detailed review and evaluation of molecular pathology reports for eligibility, and ongoing monitoring of clinical and laboratory data, assessing safety, and responsibility for analysis of emerging safety and clinical signals
• Provide clinical expertise and writing of clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs
• Leading investigator meetings and networking opportunities with academic clinical investigators
• Attending and supporting clinical site initiation visits
• Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
• Work closely with Regulatory Affairs, and multi-disciplinary team to assure timely filing of all regulatory documents and applications
• Provide Pharmacovigilance support for the clinical trials in conjunction with our PV team
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
• Serve as the clinical face of the company both internally and externally, including the scientific community and key opinion leaders
• Support study/program-level audit and inspection readiness activities as needed

Preferred Qualifications

• Subspeciality training in oncology and experience in targeted therapy lung cancer trials
• Experience with high-complexity first-in-human studies
• Experience presenting to a variety of audiences including internal teams and external medical/scientific communities
• Experience with interacting with Regulatory Authorities, such as FDA and EMA
• Excellent interpersonal and communication skills with ability to build positive, effective relationships with both internal and external stakeholders
• Ability to work productively primarily from home in a fast-paced, results-driven, highly accountable environment where you can demonstrate initiative and make a clear impact