Executive Medical Director, Clinical Development, Hematology Cell Therapy

About the role

The Executive Medical Director, Hematology will provide overall clinical scientific leadership for the cell therapy program and have responsibility for our clinical development strategy and execution of clinical trials in this area. This role will be a key partner with the Global Program Head to design the optimal development strategy for this portfolio.

Responsibilities

• Acts as medical expert and leader in interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal collaborators (e.g., Research, Early Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards.
• Uses excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.
• Uses that creativity and knowledge to easily build and defend data driven plans and decisions, both with internal scientific management and the Company’s partners / collaborators.
• Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Designs and develops smaller, yet robust and innovative FIH as well as Phase 2/3 programs.
• Drives for strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making.
• Leads dynamic and matrixed clinical teams in a fast-paced and hands-on environment.
• Leads and develops a team of MDs and clinical scientists to meet personal and business needs.

Requirements

• Demonstrated consistent track record in a range of leadership roles that include working with senior clinical development staff, establishing credibility with external collaborators such as opinion leaders and regulators, and demonstrating substantial experience in drug development (including experience with both IND and BLA/NDA submission).
• Experience in leading study start-up, directing and guiding study team execution, data cleaning, medical review, database locks, handling health authority responses are also required.

Qualifications

• A demonstrated commitment to impacting patients through drug development and the ability to work well within a team setting are critical.
• A minimum of 6-8 years of industry experience in related therapeutic area clinical development.
• Cell therapy drug development experience is preferred.
• People management experience is a plus.

Skills

• Advanced degree in medicine (MD or equivalent), with a MD/PhD strongly preferred.
• Specialized fellowship training Hematology or Oncology is preferred.

Benefits

Not specified

Pay

$390,000.00 - $527,600.00 annually

Schedule

Not specified