Sr. Medical Director, Late Clinical Development

Legend Biotech US • Somerset, NJ

23h • Hybrid

About The Position

Legend Biotech is seeking a Sr. Medical Director, Late Clinical Development to join the Clinical Development team in Somerset, NJ. This critical role significantly impacts the development and life cycle of drug development projects. The candidate will lead Late Clinical Development studies and other assigned projects, collaborating closely with Pre-Clinical, Regulatory, Safety, Medical Affairs, Translational Development, Commercial, and Biostatistics. A full understanding of GCP tenets and the relevant compliance framework for clinical development activities is essential. The ideal candidate possesses a passion for science and patients, along with an entrepreneurial drive to contribute to the organization's success.

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.

Nice To Haves

• US board certification in hematology and/or oncology
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T
• Experience in biotech
• Experience in submission of BLAs
• Experience leading meetings with health authorities

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.

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after just three (3) months of employment
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree