Medical Development Director
3 weeks ago
Title:
Medical Development Director
Company:
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 team, supporting the execution of early and late-stage clinical studies. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast-paced environment.
Provide medical expertise and leadership in designing and implementing clinical development strategies aligned with company objectives.
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 : 60% presence on site
- Position open in our 3 R&D Hubs : Cambridge (US),Paddington (UK) or Boulogne/Les Ulis (France )
- However, if the candidate is local to the area, the candidate will be expected to come into the office occasionally.
- Advanced degree, MD
- Must have experience leading all aspects of clinical trials
- Must have pharma, clinical trial /R&D experience (3-5 years)
- Rare disease experience, pediatric and or 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
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
-
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
18 hours ago
Cambridge, United States Ipsen Pharma Full timeTitle: Medical Development Director Company: 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
4 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
4 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...
-
Medical Director, Clinical Development
4 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...
-
Medical Director
2 days ago
Cambridge, United States FogPharma Full timeWhy join us? FogPharma is a biopharmaceutical company pioneering the discovery and development of Helicon™ therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, FogPharma is poised to revolutionize the medical possibilities for patients by...
-
Associate Medical Director
4 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 Biogen Idec Full timeCompany DescriptionJob Description About the role: The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic expansion,...
-
Associate Director or Director Medical Affairs
20 hours ago
Cambridge, United States Beacon Therapeutics (USA) Inc Full timeJob Description Job Description Are 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...
-
Associate Director or Director Medical Affairs
12 hours ago
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...
-
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...
-
Associate Director
1 week 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 Director
5 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
4 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...
-
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout the role:The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic...
-
Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout the role:The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic...
-
Cambridge, United States Biogen Full timeCompany DescriptionJob DescriptionAbout the role:The Medical Director, Clinical Development will focus on Multiple Sclerosis related activities in the MS Development Unit (DU) as they pertain to life cycle management activities of the marketed MS portfolio. Activities will include the support of registrational filing activities for geographic expansion,...
-
Associate Director
1 week ago
Cambridge, United States Avalyn Pharma Inc Full timeJob DescriptionJob DescriptionBenefits:401(k) matchingCompany partiesCompetitive salaryDental insuranceHealth insuranceOpportunity for advancementPaid time offParental leaveStock options planVision insuranceWellness resources Associate Director / Director, Product Development Company Overview:Avalyn Pharma is developing innovative, inhaled therapies to...