Senior Medical Director, Clinical Development (MD Required)

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 Vice President, Clinical Development, the Senior Medical Director, Clinical Development provides an excellent opportunity for a physician with experience in oncology clinical development to work within a rapidly growing company. The Senior Medical Director, Clinical Development is responsible for providing medical leadership, medical monitoring, and executional oversight of clinical studies, and to pave a path towards regulatory approval. The Nuvalent pipeline is currently focused on development of precision medicines for oncology targets; therefore, the physician will work closely with a multi-disciplinary team consisting of non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, data management, pharmacovigilance, and regulatory affairs.  The physician will also lead and participate in teleconferences with academic study investigators, safety review committees, advisory meetings with opinion leaders, and interactions with Health Authorities. This position will report to the Vice President of Clinical Development.

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
 
Competencies Include:
•    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

Qualifications: 
•    An M.D. or M.D/Ph.D. with experience in oncology is required (subspeciality training in oncology and experience in targeted therapy lung cancer trials preferred)
•    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.
•    Experience with high-complexity first-in-human studies is highly desired
•    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 is preferred.
•    Ability to travel domestically and internationally to investigator sites and medical meetings, approximately 10%

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran o