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Voyager Therapeutics, Inc.
Lexington, MA, United States
About Voyager Therapeutics Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of - and ultimately cure - neurological diseases. Our pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple oth
Job Source: Voyager Therapeutics, Inc.Voyager Therapeutics
Lexington, MA, United States
About Voyager Therapeutics Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of - and ultimately cure - neurological diseases. Our pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple oth
Job Source: Voyager TherapeuticsRelay Therapeutics
Cambridge, MA, United States
As 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 o
Job Source: Relay TherapeuticsDiscera Search
Watertown, MA, United States
A global biotech with multiple Phase I and an upcoming Phase II program is seeking an experienced Medical Director to support their clinical development. The company recently received $90mn+ in funding has multiple assets under management. Now I am looking for a highly motivated Senior Medical Director to support the Chief Medical Officer to design
Job Source: Discera SearchBarrington James
Boston, MA, United States
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Job Source: Barrington JamesOlema Oncology
Boston, MA, United States
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Job Source: Olema OncologyRepare Therapeutics
Cambridge, MA, United States
Description 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, p
Job Source: Repare TherapeuticsRelay Therapeutics
Cambridge, MA, United States
As 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 o
Job Source: Relay TherapeuticsLexington, MA, United States
About Voyager Therapeutics
Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of - and ultimately cure - neurological diseases. Our pipeline includes programs for Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.
Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc.
Job Summary
Voyager Therapeutics is seeking an outstanding neurologist with neuromuscular expertise to join our growing Development team as Medical/Senior Medical Director. The Medical/Senior Medical Director will play a key role on cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted for the clinical development of our novel TRACER AAV capsid discovery platform programs in neurological diseases. The successful candidate will have direct medical responsibility for creating clinical development plans, designing clinical studies, writing protocols, providing CRO oversight and safety monitoring of Voyager's clinical programs. The Medical Director will contribute collaboratively toward the clinical aspects of research and early-stage development programs, providing insight into treatment indications, patient populations, study designs and overall development strategies.
Key Responsibilities
Contribute to the development and execution of comprehensive clinical development plans for Voyager's development programs. Offer expert clinical advice, drawing on extensive clinical knowledge. Provide feedback on clinical study data, reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indications
Serve as a medical expert in the company, staying current with the latest research and medical advancements in the fields being studied
Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines
Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. Collaborate with study team to prepare and complete clinical study reports, investigator's brochures
Provide medical oversight for future clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial results
Build and maintain strong relationships with key opinion leaders (KOLs) and academic institutions to support the company's scientific and clinical objectives
Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives
Lead the development of scientific publications, presentations, and educational materials related to Voyager's programs
Qualifications M.D. with deep Neuroscience experience
3+ years' experience in clinical development within a biotech or pharmaceutical company
Determination on level will be determined commensurate with experience
Experience in neurology clinical development is required and experience in neuromuscular diseases and/or dementia is optimal
Experience in gene therapy drug development, RNA, nucleotide, and/or gene editing experience considered a plus
Experience working collaboratively within a multi-disciplinary team of colleagues and proven ability to interact with external experts and investigators
Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task to thrive in a small company
Experience in early-stage development programs
Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Self-starter who works with a sense of urgency and functions as a strong team player
Patient focused, passionate about science and excited about having fun while working
Effective oral and written communication skills are required, as are excellent interpersonal skills with demonstrated ability to work with a small growing team. Marked proficiency in clinical/medical writing
Integrity, honesty and highest ethical standards and a sense of personal accountability
Email Alert for Medical Director/Senior Medical Director jobs in Lexington, MA, United States
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