Sr. Medical Director/Executive Director, Early Clinical Development

About the role

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 will lead the Early Clinical Development Team for IND submission and the design, execution, and oversight of first-in-human, dose-finding clinical trials. A full understanding of tenets of FIH studies (e.g., dose selection rationale, biomarker plans) and the relevant compliance framework for clinical development activities is essential. The candidate must possess a passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

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.
• Provide 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.
• Assure that the highest quality, ethical, and 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.
• 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.
• Deliver results through effective team and peer leadership in a matrix environment.
• Manage conflicts and negotiations while providing impact and influence.
• Communicate regularly and effectively with senior leaders.
• Translate medical/clinical information into clinical development strategies.

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.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech is 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 and execution of first-in-human trials and submission of INDs.
• Experience leading pre-IND and IND meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to contribute hands-on 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.
• Highly collaborative and effective influencing skills with the ability to operate across multiple geographies.
• Strong track record of delivering results through effective team and peer leadership in a matrix environment.
• Superior interpersonal and communication skills ensuring full alignment of cross-functional teams.
• Excellent leadership, organizational, analytical, and presentation skills.
• Travel requirement up to 15-20% of the time.

Pay

The advertised pay range covers both levels of this position:

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

The base pay range is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other types of pay include performance-based bonus and/or equity for eligible roles.

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 three (3) months of employment.
• Paid time off policy including 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 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.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.