Sr. Medical Director, Late Clinical Development

Legend Biotech is seeking Sr. Medical Director, Late Clinical Development as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The (Sr.) Medical Director of Late Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects. The candidate for this role will be responsible to lead a Late Clinical Development study, and other projects as assigned, working closely with partners in Pre-Clinical, Regulatory, Safety, Medical Affairs, Translational Development, Commercial & Biostatistics. Full understanding of tenets of GCP and the relevant compliance framework for clinical development activities are essential. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

• Lead clinical science aspects of design, execution, interpretation and reporting of late-stage clinical trials.
• Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy.
• Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables.
• Medical review of clinical data including query generation and resolution.
• Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for collaboration with alliance partner, business development and other partnership activities as needed.
• Act as a champion for high standards of compliance, ethics and safety, and putting patients first.

Requirements

• MD or MD-PhD or equivalent medical degree. US board certification in hematology and/or oncology is highly desirable.
• 1+ / 3+ (Senior) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech - preferred but not required.
• Demonstrated capacity to think creatively when addressing complex situations.
• Demonstrated excellence in clinical development including the design and execution of registrational studies. Experience in submission of BLAs is highly desirable.
• Experience leading meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills.
• Able to anticipate biostatistics, regulatory, clinical operations, development sciences, pharmacovigilance, and other functional needs to ensure successful program delivery.
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project management including peer to peer interactions with academic scientific experts, KOLs and stake holders.
• Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization.
• Work effectively with a key strategic alliance partner for projects that are being jointly developed.
• Assure that the highest quality, ethical & professional values are demonstrated in all aspects of teamwork.
• Ensure compliance with corporate policies and procedures, as well as all related healthcare laws and regulations.
• Highly collaborative & effective influencing skills. The ability to operate across multiple geographies.
• Strong track record of delivering results through effective team and peer leadership in matrix.
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.

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