Role Summary
Medical Director at Arcellx will provide strategic medical oversight across clinical development programs from early to late-stage development, helping advance therapies to patients in need. Location note: roles based in our offices in Rockville, Maryland, and Redwood City, California.
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
- Required: Medical Doctor (M.D.) or non-US equivalent with hematologic malignancy experience in an academic or hospital environment; completion of a residency program and oncology-focused subspecialty fellowship strongly preferred.
- Required: 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, and strategic vision with knowledge of the field and competitive landscape.
- Required: Well-honed communication skills with the ability to collaborate effectively with cross-functional teams; excellent oral and written English communication skills.
- Required: 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
- Strong medical knowledge in hematologic malignancies and cell therapy; ability to translate clinical data into program strategy.
- Effective cross-functional collaboration and leadership; ability to influence without authority.
- Excellent written and verbal communication; scientific presentation skills.
- Strategic thinking with a global/regulatory perspective; stakeholder management.
Education
- Medical Degree (M.D.) or equivalent required.