Medical Director, Clinical Development
2 weeks ago
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 in-scope aspects of global regulatory interactions. Though this is a hybrid role, candidates must live local and be able to visit our Cambridge location 1-3 days per week as needed.
Responsibilities:
- Serves on cross-functional teams for assigned programs, working with other team members to drive program and clinical strategy to registration in applicable populations and indications
- Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP)
- Serves as the medical monitor for assigned studies (focus will be in hematology programs) including design, execution and interpretation of study data.
- Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans.
- Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
- Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Acts as liaison between Clinical Development and other internal groups at BEAM for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality and biomarker groups to facilitate and coordinate cross-functional study activities.
- Establishes strong collaborations with study investigators, outside medical experts and represents BEAM during investigator meetings and advisory boards.
- Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas
- MD, DO or equivalent ex-US medical degree with 12+ years experience, 3+ years clinical trial experience in industry is a must.
- Board certification/eligibility in hematology/oncology, or another relevant specialty highly desired.
- Must have previous patient care experience.
- Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
- Strong oral and written communication skills to influence others
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Clinical development and/or clinical experience in rare disease, cell & gene therapy is a plus
- Ability to work independently to resolve challenges
-
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
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 Director, Clinical Operations
4 weeks ago
Cambridge, United States Clinical Dynamix, Inc. Full timeRole: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...
-
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
9 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
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
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...
-
Cambridge, United States Clinical Dynamix, Inc. Full timeGlobal Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work remotely (possible meetings and functions each quarter in Waltham, MA office)The AD, Monitoring Oversight is responsible for Oversight and implementing a global sponsor oversight monitoring program within the clinical operations department. This...
-
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,...
-
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,...
-
Cambridge, United States Biogen Idec Full timeCompany DescriptionJob Description About This Role: We are seeking a highly motivated Senior Medical Director to lead development strategy and oversee the clinical development team for one or more assets in the areas of neuropsychiatry and pain in programs that span from first in human studies through filings and approval as well as post-marketing...
-
Cambridge, United States Biogen Full timeCompany DescriptionJob DescriptionAbout This Role:We are seeking a highly motivated Senior Medical Director to lead development strategy and oversee the clinical development team for one or more assets in the areas of neuropsychiatry and pain in programs that span from first in human studies through filings and approval as well as post-marketing commitments...
-
Clinical Development Director
7 days ago
Cambridge, United States Orro Full timeOne Kendall Square, Building 600 Cambridge, MA 02139 Korro Bio, a publicly traded biopharmaceutical company, pioneers the frontier of genetic medicine by harnessing the power of RNA editing. Our mission is clear: to discover, develop, and commercialize innovative therapies addressing both rare and prevalent diseases. At Korro, we're not just following...
-
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
-
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...
-
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...
-
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...
