Executive Medical Director, Clinical Development, Classical Hematology

Regeneron Pharmaceuticals; United States; Remote; USD 150,000 - 250,000; Full time

Job summary

An established industry player is seeking an Executive Medical Director for Hematology to lead clinical development strategies and execution of trials. This pivotal role involves collaborating with external and internal partners, driving innovative strategies to expedite drug development, and ensuring impactful patient outcomes. The ideal candidate will have a strong background in clinical leadership, drug development, and regulatory interactions, with a proven track record of managing teams in a dynamic environment. If you are passionate about making a difference in patients' lives through drug development, this opportunity is tailored for you.

Qualifications

• 6-8 years of industry experience in clinical development is required.
• Experience with IND and BLA/NDA submission is essential.

Responsibilities

• Provide clinical scientific leadership for hematology programs.
• Lead multi-disciplinary teams and develop innovative clinical strategies.

Skills

Clinical leadership

Drug development

Regulatory interactions

Consensus-building

Team management

Education

MD or equivalent

MD/PhD

Job description

The Executive Medical Director, Hematology, will provide overall clinical scientific leadership for a classical hematology 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. This role requires an impactful and highly hard-working individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to hematology clinical research. The Executive Medical Director, Hematology reports directly to the SVP, Hematology.

A typical day in the life may include the following:

• 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.

This job may be for you if you have the following:

• 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.
• A strong commitment to impacting patients through drug development and the ability to work well within a team setting are critical.

In order to be considered for this position, you must have an advanced degree in medicine (MD or equivalent), with a MD/PhD strongly preferred. The incumbent will have a minimum of 6-8 years of industry experience in related therapeutic area clinical development, including experience with parenterally administered small molecules and biopharmaceuticals. REGN expects a total of 12 years of experience in clinical development, with at least 6-8 years in industry and the remainder of experience acquired in an academic setting. At least 5 years of people management experience required; this may include management in a matrix environment. This role requires a minimum of 3 non-consecutive days on-site weekly in Tarrytown, NY or Basking Ridge, NJ.