Senior Director, Clinical Development - Cell Therapy

Role Summary

The Sr. Director, Clinical Development is a pivotal role within our organization, responsible for providing clinical leadership and strategic direction for one of our cutting-edge cell therapy programs, including those in pivotal stage development. This individual will play a crucial role in advancing our cell therapy initiative from early-phase research through to commercialization.

Responsibilities

• Lead the design, implementation, and oversight of clinical trials for cell therapy products.
• Analyze and interpret clinical trial data and provide medical input for clinical study reports.
• Ensure the scientific integrity of clinical studies and compliance with regulatory requirements.
• Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs).
• Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials and develop and implement risk management strategies.
• Collaborate with regulatory affairs to prepare and review regulatory submissions (IND, BLA, etc.).
• May develop and review scientific content for regulatory documents, scientific communications and marketing materials.
• Provide guidance and mentorship to members of the clinical development team; support professional development opportunities for team members.
• May represent clinical development in executive leadership meetings and contribute to strategic decision-making processes.
• Participate in cross-functional project teams and contribute to strategic planning.
• Provide medical expertise to support product development, marketing, and sales teams.
• Ensure adherence to all regulatory guidelines and Good Clinical Practice (GCP) standards.
• Substantially develop the Clinical Development Plan (CDP) and clinical trial protocols.

Qualifications

• Preferred Education:
  • M.D. or M.D./PhD; current/prior board certification in oncology, hematology, or a related field is preferred.
  • 8+ years of related experience
• Preferred Experience:
  • Minimum of 5 years of clinical research experience in oncology; experience with cell or immunotherapy is preferred.
  • Demonstrated experience in the design, execution, and oversight of clinical trials.
  • Experience with regulatory submissions and interactions with regulatory agencies is highly desirable.

Skills

• In-depth knowledge of regulatory requirements and GCP standards.
• Strong analytical and problem-solving skills, with the ability to interpret complex clinical data.
• Excellent leadership and cross-functional collaboration/team leadership capability.
• Strong communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.

Education

• Preferred: M.D. or M.D./PhD; board certification in oncology, hematology, or related field.