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Senior Medical Director - Watertown, United States - C4 Therapeutics Inc
4 weeks ago
Description
About C4 Therapeutics:
C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives.
C4T is progressing targeted oncology programs through clinical studies and leveraging its TORPEDO platform to efficiently design and optimize small-molecule medicines to address difficult-to-treat diseases.
C4T's degrader medicines are designed to harness the body's natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes.
For more information, please visitJob Summary
C4 Therapeutics is seeking an experienced Medical Director/Senior Medical Director to serve as the Clinical Lead for one or more oncology clinical trials.
The C4 Therapeutics pipeline is currently focused in research and early clinical development; therefore, the Medical Director will work closely with scientists in discovery research and translational medicine, as well as non-clinical, DMPK/clinical pharmacology, program management, biostatistics, regulatory affairs, and clinical operations on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support in-scope aspects of global regulatory interactions.
.The physician may also lead meetings with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities.
A genuine interest and understanding of the science supporting the C4 therapeutics pipeline, an ability to work in a multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success.
Provide medical guidance and leadership to the strategic planning and execution of the development program through close collaboration with cross-functional teams in a highly matrixed environment.
Lead the design and writing of oncology clinical study protocols from first-in-human phase 1 through pivotal studies that will support regulatory approvals.
Medical monitoring of clinical trials, including communication with investigators regarding patient eligibility, protocol and medical questions, and evaluation of clinical and safety data.
Lead the review of clinical sections of key documents, including Investigator's Brochures, IND summary documents, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
Foster collegial and productive relationships with clinical investigators through in-person meetings, video conferences, and email communications.
Attend and support virtual clinical site initiation visits and lead investigator meetings; when necessary attend onsite visits.
Work closely with Pharmacovigilance to support all PV-related activities, including SAE reporting, adverse event review and signal detection, DSUR, and IB development.
Perform 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 with the CMO and SVP of clinical development on broader strategies and development of the clinical development plans for various programs.
Qualifications
MD/DO required; clinical experience preferred.
3-5 years of relevant experience in oncology drug development.
Clinical practice experience preferred.
Strong leadership skills and proven experience developing, planning, designing and executing early and late-stage programs. Experience with high-complexity first-in-human studies is highly desired.
Demonstrated ability to lead, collaborate, and mentor teams and direct reports within a dynamic, fast-paced environment.
Thorough understanding of the drug development process from IND through NDA, including clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance.
Experience leading the clinical aspects of interactions with Regulatory Authorities, such as FDA and EMA preferred.
Experience presenting to a wide variety of audiences including internal teams, medical and scientific communities.
Key Capabilities:
The ability to lead through influence, recognizing that building positive relationships is the essential foundation of collaboration and productivity.
Communicates in an open and clear manner, listening effectively and inviting response and discussion.
Genuine interest and purposefulness in the career development of direct reports.
Effectively transitions between strategy and operational execution, with the adaptability to modify plans as required based on changes in priority.
Proactive thinking; anticipates problems and plans accordingly.
Ability to travel domestically and internationally, 10-20%.
C4 Therapeutics is an Equal Opportunity Employer.
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