- Hands-on involvement in the design and writing of oncology clinical study protocols from first-in-human phase 1 through registrational studies that will support regulatory approvals.
- Be the clinical lead for clinical trials, including performing detailed review and evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase 1, and assessing early pharmacodynamics and clinical signals of activity.
- 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 regular teleconferences 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.
- 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.
- 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%.
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Senior Medical Director, Clinical Development - Cambridge, United States - Nuvalent, Inc.
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 Vice President of Clinical Development, This is an excellent opportunity for a Sr. Medical Director, Clinical Development physician with experience in oncology clinical development to work within a rapidly growing company. The Senior Medical Director, Clinical Development is responsible for designing and executing clinical studies, helping to create the clinical development plan for new compounds, 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 scientists in discovery research and translational medicine, as well as 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:
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from "" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a "no-" email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
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