Medical Director
3 weeks ago
Job Responsibilities
Clinical Trial Strategy and Design:
Collaborate with cross-functional teams (including Clinical Operations, Biostatistics Regulatory Affairs, Patient Safety, and Pharmacology/Pharmacometrics) to design and implement clinical trials
Ensure that clinical trial protocols align with scientific and regulatory requirements
Oversee patient recruitment, data collection, and safety monitoring during trials
Medical Oversight:
Provide medical expertise to study teams, investigators, and site staff
Review and interpret clinical trial data, including safety and efficacy endpoints
Make informed decisions based on medical insights to optimize trial outcomes
Regulatory Interactions:
Engage with regulatory agencies (such as the FDA or EMA) during clinical development
Prepare and submit clinical trial applications, investigator brochures, and other regulatory documents
Address regulatory queries and ensure compliance with guidelines
Clinical Development Strategy:
Contribute to the overall clinical development strategy for the company s pipeline products
Identify opportunities for expansion into new indications or patient populations
Evaluate scientific literature and competitive landscape to inform strategic decisions
KOL Engagement and Scientific Communication:
Build relationships with Key Opinion Leaders (KOLs) in relevant therapeutic areas
Present clinical trial results at scientific conferences and meetings
Collaborate with external experts to enhance product understanding
Team Leadership and Mentorship:
Depending on the candidate's expertise level, the responsibilities may include leading a team of clinical professionals, including Clinical Scientists and Medical Monitors
Effectively fosters productive and collegial working relationships with internal and external stakeholders in a cross-functional, matrix environment
Additional Info
This is a hybrid/remote role for the candidate; however, if the candidate is local to the area, the candidate will be expected to come into the office occasionally
Advanced scientific degree (MD or DO, PhD, PharmD)
Must have experience leading all aspects of clinical trials
Must have pharma clinical trial /R&D experience (3-5 years)
Rare disease experience and or gastroenterology/hepatology experience in clinical development preferred
Solution- and results-oriented, with a sense of urgency
Must have experience and be willing to perform in-depth clinical data review
-
Associate Medical Director
3 weeks ago
Cambridge, United States The Steely Group Full timeThe Associate Medical Director is a medical doctor who provides medical and scientific leadership and oversees assigned clinical development programs and associated clinical trials. Responsibilities: Serves as a cross-functional medical lead on clini Medical Director, Associate, Director, Medical, Clinical Research, Operations, Healthcare, Staffing
-
Cambridge, United States Beacon Therapeutics (USA) Inc Full timeJoin our team based in Cambridge, MA, and lead pioneering projects in biotech that make a real difference in people's lives. You will receive great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, Employee Discounts, and Employer paid STD/LTD. Be part of a...
-
Cambridge, United States Beacon Therapeutics (USA) Inc Full timeJob DescriptionJob DescriptionAre you a driven Medical Affairs Leader seeking a new challenge in a fully remote position? Beacon Therapeutics invites you to apply for the Associate Director or Director Medical Affairs role. Here, you can showcase your expertise and drive key initiatives. Competitive pay aligns with industry standards, promising recognition...
-
Senior Medical Director
2 days ago
Cambridge, United States Repare Therapeutics Inc. Full timeReporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval. You will have experience in the drug development process, particularly early phase...
-
Senior Medical Director
3 weeks ago
Cambridge, United States Repare Therapeutics Inc. Full timeReporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval. You will have experience in the drug development process, particularly early phase...
-
Senior Medical Director
2 weeks ago
Cambridge, United States Repare Therapeutics Full timeDescription Reporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval. You will have experience in the drug development process, particularly...
-
Medical Development Director
3 weeks ago
Cambridge, United States Ipsen Biopharmaceuticals, Inc. Full timeTitle:Medical Development DirectorCompany:Ipsen Bioscience, Inc.Job Description:Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development...
-
Medical Development Director
3 weeks ago
Cambridge, Massachusetts, United States Ipsen Biopharmaceuticals, Inc. Full timeTitle:Medical Development DirectorCompany:Ipsen Bioscience, Inc.Job Description:Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development...
-
Medical Development Director
3 weeks ago
Cambridge, United States BioSpace Full timeJob DetailsTitle:Medical Development DirectorCompany:Ipsen Bioscience, Inc.Job Description:Ipsen is seeking an experienced Medical Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical...
-
Associate Medical Director US
1 day ago
Cambridge, United States Biogen Full timeAbout this role The Associate Medical Director Rare Disease role is a part of US (United States) Medical Affairs, a strategic partner within Biogen, that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful pa Medical Director, Medical, Director, Associate, Clinical, Strategy, Technology
-
Medical Director, Clinical Development
3 weeks ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
-
Medical Director, Clinical Development
2 weeks ago
Cambridge, United States Beam Therapeutics Inc. Full timePosition Overview: The Medical Director in Clinical Development will serve as the Medical Lead for base editing gene therapies in hematology. The Medical Director will work with cross-functional multidisciplinary study teams on clinical development strategy, clinical trial design and execution including medical monitoring of assigned trials, and support...
-
Senior Medical Director
3 weeks ago
Cambridge, United States Third Rock Ventures Full timeAs a Senior Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration. Specifically, you will collaborate with senior medical staff to drive clinical strategy, clinical trial design, and execution. Working cross-functionally with clinical project management, regulatory affairs, clinical operations,...
-
Medical Director
2 weeks ago
Cambridge, United States Precision Life Sciences Full timeJob Description: Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. This position will fill an open vacancy while an FTE is hired. Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements. Provide...
-
Director, Regulatory and Medical Writing
6 days ago
Cambridge, United States Sana Biotechnology Full timeAbout the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director, Regulatory and Medical Writing you will report to the VP, Head of Clinical Regulatory and Quality to support...
-
Director, Regulatory and Medical Writing
5 days ago
Cambridge, United States BioSpace Full timeJob DetailsAbout the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director, Regulatory and Medical Writing you will report to the VP, Head of Clinical Regulatory and Quality to...
-
Director, Regulatory and Medical Writing
7 days ago
Cambridge, Massachusetts, United States Sana Biotechnology Full timeAbout the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director, Regulatory and Medical Writing you will report to the VP, Head of Clinical Regulatory and Quality to support the...
-
Associate Director
7 days ago
Cambridge, United States Avalyn Pharma Inc Full timeJob DescriptionJob DescriptionAssociate Director / Director, Product Development Company Overview:Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for treatment of rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C...
-
Senior Medical Manager US
1 day ago
Cambridge, United States Biogen Full timeAbout this role. The Senior Medical Manager is a part of US Medical Rare Disease, a strategic partner within Biogen that helps inform medical practice across our therapeutic areas and pipeline to improve meaningful patient outcomes. As a key member o Medical, Manager, Medical Director, Senior, Clinical, Communications, Technology, Healthcare
-
Director of Manufacturing
1 month ago
Cambridge, United States Nanobiosym Full timeSUMMARY Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. This hyper growth company allows for unique career opportunities with strong...