Sr. Medical Director/Executive Director, Early Clinical Development

Role Overview

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.

Key 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.

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.
• 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 and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs.
• Experience leading pre-IND and IND 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 biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery.
• 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 stakeholders.
• Ensure the highest quality, ethical & professional values are demonstrated in all aspects of the team work.
• Assure 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.
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into clinical development strategies.
• Able to travel up to 15-20% of the time.

Pay Range

The advertised pay range covers both levels of this position. Here's the base pay range by level:

• Sr. Medical Director, Early Clinical Development: $294,483 - $386,511
• Executive Medical Director, Early Clinical Development: $338,656- $444,486

Benefits and Paid Time Off

• Medical, dental, and vision insurance as well as a 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, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.