Executive Director, Clinical Development

2 weeks ago

Princeton, United States The Carolan Group Full time

Job Title: Executive Director, Clinical Development (Oncology)

Location: Princeton, NJ

Reports To: Chief Medical Officer / Senior Vice President of Clinical Development

Position Summary:

The Executive Director of Clinical Development in Oncology will lead clinical strategy and operations for a robust oncology portfolio. This role is responsible for overseeing the design, execution, and delivery of clinical trials across various phases, with a focus on innovative approaches in cancer treatment. The Executive Director will play a pivotal role in driving program progress through cross-functional leadership, regulatory compliance, and strategic partnerships. This position offers an exciting opportunity to shape the future of oncology clinical development within a dynamic, patient-focused organization.

Key Responsibilities:

  • Strategic Leadership:
  • Lead the oncology clinical development program from early phase through post-marketing.
  • Develop and execute clinical development strategies aligned with corporate goals and regulatory guidelines.
  • Collaborate with the executive leadership team to inform overall oncology portfolio strategy and drive pipeline growth.
  • Clinical Trial Oversight:
  • Oversee design, initiation, execution, and management of clinical trials, ensuring they meet strategic, operational, and regulatory objectives.
  • Lead protocol development, study design, and clinical endpoint selection to support efficacy and safety objectives.
  • Ensure that clinical trials are conducted with the highest ethical and scientific standards, while managing timelines and budgets.
  • Cross-Functional Collaboration:
  • Partner with regulatory affairs, medical affairs, commercial, and scientific teams to ensure cohesive strategy and alignment across the product lifecycle.
  • Engage with R&D teams to ensure seamless transitions from preclinical to clinical stages and translate scientific insights into clinical application.
  • Act as the primary point of contact for key opinion leaders (KOLs), advisory boards, and external collaborators.
  • Regulatory and Compliance Oversight:
  • Lead regulatory interactions and submissions to agencies such as the FDA, EMA, and other global authorities.
  • Ensure adherence to all relevant regulatory, quality, and ethical guidelines (e.g., GCP, ICH).
  • Prepare and present clinical data to regulatory agencies, advisory boards, and internal stakeholders.
  • Team Leadership and Development:
  • Build and mentor a high-performing clinical development team, fostering an environment of continuous learning and professional growth.
  • Provide scientific and operational guidance to team members and manage cross-functional project teams.
  • Drive a culture of innovation, accountability, and collaboration within the clinical development organization.

Qualifications:

  • Education: MD, PhD, or equivalent advanced degree in a relevant scientific discipline (e.g., Oncology, Hematology, Immunology, Pharmacology).
  • Experience:
  • Minimum of 10 years of experience in oncology clinical development, with a track record of leadership in early- and late-stage clinical trials.
  • Strong experience in regulatory submissions, including INDs, NDAs, BLAs, or MAAs, and interacting with regulatory agencies.
  • Proven ability to translate scientific insights into clinical development strategies and execute clinical trials that meet program objectives.
  • Experience leading and developing clinical teams, with demonstrated success in managing cross-functional, global teams.
  • Skills:
  • Strong scientific and analytical skills, with the ability to interpret complex data and apply it to clinical strategy.
  • Excellent written and verbal communication skills, with the ability to present complex information to diverse audiences.
  • Exceptional leadership and interpersonal skills, with a strong ability to influence, build consensus, and manage internal and external relationships.

Preferred Qualifications:

  • Previous experience in both large pharma and biotech environments is a plus.
  • Background in immuno-oncology, CAR-T, or other cutting-edge cancer therapies.
  • Demonstrated ability to drive clinical development programs in highly matrixed environments.

Why Join Us:

  • Impactful Work: Be part of a team that is pioneering transformative therapies in oncology and making a difference in patients’ lives.
  • Innovative Culture: Join a company that values innovation, collaboration, and scientific excellence.
  • Career Growth: Opportunities for career development and leadership in a dynamic and growing organization.

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