Sr. Medical Director/Executive Director, Early Clinical Development

Legend Biotech US•Somerset, NJ

1d•Hybrid

About The Position

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, the company is developing advanced cell therapies across diverse technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. With three R&D sites worldwide, Legend Biotech applies innovative technologies to discover safe, efficacious, and cutting-edge therapeutics for patients globally. Legend Biotech has a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel), combining strengths to advance immunotherapy in multiple myeloma treatment. The Sr. Medical Director/Executive Director of Early Clinical Development is a critical role within the Clinical Development team, based in Somerset, NJ, with significant impact on drug development projects. This role involves leading the Early Clinical Development Team, overseeing IND submission, and the design, execution, and oversight of first-in-human, dose-finding clinical trials. A full understanding of FIH study tenets (e.g., dose selection rationale, biomarker plans) and the relevant compliance framework for clinical development activities are essential. The ideal candidate will possess 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 with US board certification in hematology and/or oncology.
3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required.
Demonstrated capacity to think creatively when addressing complex situations
Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs.
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 biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development 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.
Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the team work
Ensures compliance with corporate policies and procedures, as well as, all related healthcare laws and regulations
Highly collaborative & effective influencing skills and 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

Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
Experience in biotech - preferred but not required.
Experience leading pre-IND and IND meetings with health authorities is highly desirable.

Responsibilities

Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) 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.
Collaborate with academic scientists, clinical experts, and study investigators.
Represent and advocate for the project in internal and external venues.
Clinical leadership for business development and 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