Director, Clinical Development (MD)

仕事内容

The Medical Director will lead the execution of multiple clinical trials in hematologic malignancies, partnering closely with internal and external stakeholders to advance a novel CAR T-cell therapy for patients. This role requires strong leadership and exceptional cross‑functional collaboration, working hand‑in‑hand with study start‑up and operational teams to ensure efficient and high‑quality trial delivery. The Medical Director will also build and maintain productive relationships with external clinical sites to support successful study conduct. In addition, this role includes direct participation in regulatory interactions to facilitate and progress study activities.

Responsibilities include, but are not limited to:

• Provide medical monitoring to multiple oncology clinical trials

• Lead project teams to design and implement clinical studies

• Write protocols, investigator brochures, clinical study reports and review clinical trial documents

• Conduct investigator meetings and lead site initiation visits with clinical trial investigators

• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets

• Translate findings from research and nonclinical studies into clinical development opportunities

• Interact with clinical investigators and thought leaders

• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines

• Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner

• Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs

• Perform other duties as required

• Support, provide input into regulatory filing documents, conduct regulatory filings

Basic Qualifications:

• MD or equivalent with 4+ years of experience managing oncology trials

Preferred Qualifications:

• Board certification/specialization in Hematology or Oncology

• At least 2 years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience

• Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies

• Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options

• Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of Kite

• Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators

• Demonstrated ability to work well in teams in a cross functional manner

• Ability to communicate and work independently with scientific/technical personnel

• Ability to think critically, and demonstrated troubleshooting and problem solving skills

• Self-motivated and willing to accept temporary responsibilities outside of initial job description

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

• May travel up to 30%