Medical Director

Role Summary

Medical Director at Arcellx providing strategic oversight to clinical development programs across indications from early to late-stage development, helping advance therapies to patients in need.

Responsibilities

• Contribute to the development and implementation of clinical development plans for cell therapy programs.
• Provide medical oversight and strategic input into study design, protocol development, and endpoint selection.
• Serve as the medical lead for clinical trials, including oversight of patient safety and adverse event management.
• Collaborate with clinical operations and pharmacovigilance teams to ensure effective medical monitoring and risk management.
• Interface with regulatory authorities on clinical development plans, study protocols, and data submissions.
• Contribute to the preparation of regulatory documents (e.g., IND/IMPD, BLA/MAA) and responses to inquiries.
• Analyze clinical trial data, interpret results, and contribute to the development of clinical study reports and publications.
• Work closely with biostatistics and data management teams to ensure robust data analysis and reporting.
• Collaborate with external experts, investigators, and advisory boards to gather insights and support clinical trial execution.
• Represent the company at scientific conferences, symposia, and external meetings.
• Partner with translational research, manufacturing, and regulatory affairs teams to integrate medical insights into program strategies.
• Collaborate with business development and commercial teams to support product positioning and market access strategies.

Qualifications

• Medical Doctor (M.D.) or non-US equivalent of M.D. with hematologic malignancy experience in an academic or hospital environment. Residency completed; oncology-focused subspecialty fellowship strongly preferred.
• 5+ years of relevant clinical trial experience in the pharmaceutical industry, academia, or equivalent, including:
  • Regulatory submission support
  • Medical writing oversight for trial related documents
  • Strategic vision including understanding of the field, knowledge of competitive landscape, and network of academic investigators
• Well-hon ed communication skills with the ability to collaborate effectively with cross-functional teams.
• Excellent oral and written English communication skills.
• Demonstrated success addressing complex problems and creating solutions for one or more programs.
• Proven leadership skills with the ability to influence and guide decision making in a fast-paced environment.

Skills

• Strategic medical leadership and cross-functional collaboration
• Clinical trial design, execution, and regulatory communications
• Data interpretation and clinical study reporting
• Stakeholder engagement with KOLs and advisory boards

Education

• Medical degree (M.D.) or equivalent; oncology-focused subspecialty fellowship preferred