- 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 discussions with internal and external stakeholders, such as investigator meetings, dose escalation meetings, advisory boards, etc.
- 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.
- Contribute to the planning and provide medical review of publications.
- 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.
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
- 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.
- Comfort and acumen with interpreting pre-clinical and clinical data in the context of evolving development strategy.
- 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.
- 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.
- Demonstrates initiative by approaching problem-solving with a positive, team-oriented attitude.
- Proactive thinking; anticipates problems and plans accordingly.
- Ability to travel domestically and internationally, 10-20%.
-
Medical Director
1 week ago
Charles River Community Health Brighton, United StatesMedical Director · CLASSIFICATION/STATUS: Exempt, Full Time, Permanent · IMMEDIATE SUPERVISOR: Chief Clinical Officer · SUPERVISORY RESPONSIBILITIES: Associate Medical Directors · FLEXIBLE WORK: Hybrid schedule option · PAY RANGE: Band 11: MD ($180,000-$225,000)/year · WHO YOU AR ...
-
Medical Director
1 week ago
Charles River Community Health Brighton, United StatesMedical DirectorCLASSIFICATION/STATUS: Exempt, Full Time, PermanentIMMEDIATE SUPERVISOR: Chief Clinical OfficerSUPERVISORY RESPONSIBILITIES: Associate Medical DirectorsFLEXIBLE WORK: Hybrid schedule optionPAY RANGE: Band 10: ($165,000 - $195,000/year)WHO YOU ARE:YOUR ROLE & IMPAC ...
-
Medical Director
4 days ago
QurAlis Cambridge, United StatesABOUT THE COMPANY · At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic ...
-
Medical Director
1 week ago
ONO PHARMA USA Cambridge, United StatesMedical Director level role that provides strategic oversight for clinical development programs and associated clinical trials. · Ensures the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the ...
-
Medical Director
3 days ago
Charles River Community Health Brighton, United StatesMedical Director · CLASSIFICATION/STATUS: Exempt, Full Time, Permanent · IMMEDIATE SUPERVISOR: Chief Clinical Officer · SUPERVISORY RESPONSIBILITIES: Associate Medical Directors · FLEXIBLE WORK: Hybrid schedule option · PAY RANGE: Band 11: MD ($180,000-$225,000)/year · WHO Y ...
-
Medical Director
3 weeks ago
Apex Ventures Logan, United StatesThere are many reasons to collaborate with European Medical Consulting Adam. In the following section, you will see how you can benefit from our free services and save valuable time: * You will have access to exclusive and unpublished job opportunities * Our relocation service wi ...
-
Medical Director
6 days ago
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · The Medical Director of Ophthalmology will be a key contributor to the Ophthalmology Program at Apellis. This position will have oversight of the clinical studies in Geographic Atrophy, and potentially participate in clinical d ...
-
Associate Medical Director, Medical Affairs
1 week ago
AbbVie Waltham, United States Full timeJob Description · Purpose: · The Associate Medical Director provides specialist medical/scientific strategic and operational input into core medical affairs activities within their TA inclusive of healthcare professional/provider interactions; generation of clinical and scientif ...
-
Veterinary Medical Director
6 days ago
Desort Watertown, United StatesFull time Veterinary Medical Director - Exceptional Opportunity, Excellent Compensation - Watertown, MA · We are seeking a full-time Veterinary Medical Director to join our team in Watertown, MA. The ideal candidate will have a DVM or equivalent degree, and be proficient in all ...
-
Senior Medical Director
8 hours ago
C4 Therapeutics Watertown, United StatesAbout 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 ...
-
Medical Director/Psychiatrist
15 hours ago
INSTITUTE FOR HEALTH Watertown, United StatesJob Description · Job DescriptionMedical Director/PsychiatristPosition Type: Consultant 6 -8 hours/week. · Location: Watertown / Hybrid (remote and on-site) · Salary Range: 150/ per hour · The Institute for Health and Recovery (IHR) is a statewide service, research, policy, progr ...
-
Medical Director
2 weeks ago
VCA Antech, Inc. Brookline, United StatesVCA Metro Cat Hospital located in Brookline, MA is looking for a Medical Director who, above all else, loves cats and also enjoys practicing advanced medicine with a cohesive, tenured team. · Metro Cat Hospital has a well-educated, friendly cat-loving team that strives to partner ...
-
Senior Medical Director
1 week ago
C4 Therapeutics Inc Watertown, United StatesJob Description · Job DescriptionAbout 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 pati ...
-
Medical Director, Pharmacovigilance
1 week ago
Deciphera Pharmaceuticals Watertown, United StatesCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...
-
Medical Director
1 week ago
VCA Animal Hospitals Brookline, United States**VCA** **Metro Cat Hospital** located in Brookline, MA is looking for a **Medical Director** who, above all else, loves cats and also enjoys practicing advanced medicine with a cohesive, tenured team. · Metro Cat Hospital has a well-educated, friendly cat-loving team that striv ...
-
Executive Director, Medical Director
1 week ago
Dyne Tx Waltham, United StatesOur commitment to people with muscle diseases · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing m ...
-
Executive Director, Medical Director
1 week ago
Dyne Therapeutics, Inc. Waltham, United StatesCompany Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide thera ...
-
Director Medical Writing
2 days ago
Life Science People Cambridge, United StatesJob Title: Director, Medical Writing · Location: Cambridge, MA · About Us: We are a pioneering biotechnology company based in Cambridge, MA, dedicated to the research, development, and commercialization of innovative treatments for central nervous system (CNS) disorders, with a p ...
-
Director, Medical Writing
3 weeks ago
Bicycle Therapeutics Cambridge, United StatesBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small mole ...
-
Veterinarian Medical Director
2 weeks ago
Cambridge Animal Hospital Cambridge, United StatesWith locations in Beloit, Janesville, and Cambridge, Wisconsin, Badger Veterinary Hospital is southern Wisconsins leading full-service mixed animal practice As our practice is growing, we are seeking a Medical Director small animal veterinarian. DVMs with interest in small rumi ...
Senior Medical Director - Watertown, United States - C4 Therapeutics, Inc.
1 month 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.
Key Capabilities:
