Legend Biotech
Legend Biotech is seeking a
Medical Director
as part of the
Clinical Development
team based in
Somerset, NJ .
Role Overview The Clinical Research Physician (CRP) plays a critical role in the company, impacting drug development projects throughout their lifecycle. The CRP will provide strategic leadership in developing the Clinical Development Plan (CDP), collaborating closely with teams in Pre-Clinical, Regulatory, Safety, Medical Affairs, and other functions. Responsibilities include developing and implementing the CDP, leading new product development from IND to submission, managing Clinical Research Scientists, and ensuring program consistency and alignment across studies. The candidate should have a passion for science and patient care, with an entrepreneurial drive. If involved in co-development programs, the CRP will serve as the medical lead on the trial, providing strategic oversight and fostering collaboration with partners.
Key Responsibilities
Design and ensure proper execution of Development Plans (CDPs), clinical trials, and protocols in accordance with GCP regulations.
Lead clinical programs across various indications, focusing on Phases 1-3, including biomarker and proof-of-concept studies, aligning with company goals and proactively managing risks.
Provide medical and scientific expertise to study teams and stakeholders, and assist in preparing abstracts, manuscripts, and presentations for external meetings.
Anticipate industry and medical trends affecting product viability and incorporate insights into planning.
Communicate strategic vision and operational plans to motivate and lead project teams.
Author and review critical regulatory documents, including INDs, IBs, protocols, CTAs, and clinical reports.
Oversee clinical data review, adverse event analysis, and data queries.
Collaborate with cross-functional teams, including discovery, regulatory, safety, and medical affairs.
Engage with regulatory authorities during meetings and scientific advice sessions.
Define project timelines, deliverables, and ensure adherence to quality, budget, and ethical standards.
Manage clinical development budgets and resources effectively.
Lead external and internal meetings, and build effective working relationships across functions and geographies.
Identify and mitigate project risks, providing regular progress reports to senior leadership.
Represent the Clinical function in cross-functional activities and support process improvements.
Provide clinical leadership for business development and partnerships.
Ensure compliance with policies, healthcare laws, and regulations.
Requirements
MD or MD-PhD or equivalent.
Experience in Oncology/Hematology & CAR-T is highly desirable.
At least 2 years of pharmaceutical experience as a Medical Director, or 5 years as a Senior Medical Director.
Experience leading registrational clinical studies.
Deep clinical knowledge and medical practice experience.
Strong analytical, scientific reasoning, and understanding of drug development processes.
Knowledge of regulatory interactions, IND, NDA/BLA submissions preferred.
Proven leadership skills, including team management and mentorship.
Excellent communication, interpersonal, and negotiation skills.
Ability to operate effectively across multiple geographies and teams.
Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace.
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Medical Director
as part of the
Clinical Development
team based in
Somerset, NJ .
Role Overview The Clinical Research Physician (CRP) plays a critical role in the company, impacting drug development projects throughout their lifecycle. The CRP will provide strategic leadership in developing the Clinical Development Plan (CDP), collaborating closely with teams in Pre-Clinical, Regulatory, Safety, Medical Affairs, and other functions. Responsibilities include developing and implementing the CDP, leading new product development from IND to submission, managing Clinical Research Scientists, and ensuring program consistency and alignment across studies. The candidate should have a passion for science and patient care, with an entrepreneurial drive. If involved in co-development programs, the CRP will serve as the medical lead on the trial, providing strategic oversight and fostering collaboration with partners.
Key Responsibilities
Design and ensure proper execution of Development Plans (CDPs), clinical trials, and protocols in accordance with GCP regulations.
Lead clinical programs across various indications, focusing on Phases 1-3, including biomarker and proof-of-concept studies, aligning with company goals and proactively managing risks.
Provide medical and scientific expertise to study teams and stakeholders, and assist in preparing abstracts, manuscripts, and presentations for external meetings.
Anticipate industry and medical trends affecting product viability and incorporate insights into planning.
Communicate strategic vision and operational plans to motivate and lead project teams.
Author and review critical regulatory documents, including INDs, IBs, protocols, CTAs, and clinical reports.
Oversee clinical data review, adverse event analysis, and data queries.
Collaborate with cross-functional teams, including discovery, regulatory, safety, and medical affairs.
Engage with regulatory authorities during meetings and scientific advice sessions.
Define project timelines, deliverables, and ensure adherence to quality, budget, and ethical standards.
Manage clinical development budgets and resources effectively.
Lead external and internal meetings, and build effective working relationships across functions and geographies.
Identify and mitigate project risks, providing regular progress reports to senior leadership.
Represent the Clinical function in cross-functional activities and support process improvements.
Provide clinical leadership for business development and partnerships.
Ensure compliance with policies, healthcare laws, and regulations.
Requirements
MD or MD-PhD or equivalent.
Experience in Oncology/Hematology & CAR-T is highly desirable.
At least 2 years of pharmaceutical experience as a Medical Director, or 5 years as a Senior Medical Director.
Experience leading registrational clinical studies.
Deep clinical knowledge and medical practice experience.
Strong analytical, scientific reasoning, and understanding of drug development processes.
Knowledge of regulatory interactions, IND, NDA/BLA submissions preferred.
Proven leadership skills, including team management and mentorship.
Excellent communication, interpersonal, and negotiation skills.
Ability to operate effectively across multiple geographies and teams.
Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace.
#J-18808-Ljbffr