Sr. Medical Director/Executive Director, Early Clinical Development
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, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. The Sr. Medical Director/Executive Director of Early 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 the Early Clinical Development Team, for IND submission and the design, execution and oversight of first-in-human, dose finding clinical trials. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, etc) 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.
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
- Performance-based bonus and/or equity is available to employees in eligible roles
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
Number of Employees
501-1,000 employees
