Medical Director, Cell & Gene Therapy Strategy

CTI Clinical Trial Services Inc; United States; Hybrid; USD 250,000 - 450,000; Full time

Job summary

CTI Clinical Trial Services Inc. seeks a Medical Director to lead medical strategy and oversee clinical development across awarded trials, with emphasis on cell and gene therapies.

The role drives cross-functional collaboration, ensures scientific rigor, and guides regulatory interactions to support sponsor objectives. The successful candidate will bring board-certified credentials, 3+ years in clinical development, and strong leadership.

Qualifications

• Medical degree from an accredited school.
• Board certification in a medical specialty.
• At least 3 years of clinical research/clinical development experience.
• Knowledge of ICH-GCP, clinical trial design, statistics, and regulatory/clinical development process.
• Previous experience in a CRO or industry role preferred.

Responsibilities

• Drive growth of a therapeutic area portfolio through medical and clinical development expertise and by providing medical oversight of awarded clinical trials.
• Participate in the lifecycle of CTI’s work from early engagement to clinical consulting to RFP and bid defenses to clinical trial execution and delivery.
• Accountable for medical oversight and management of awarded studies, including protocol review, eligibility discussions, oversight of medical issues, training of internal and site teams, safety review, and medical support of regulatory issues.
• Early engagement business development activities, including providing advice and recommendations on protocols and clinical development plans, assessing sponsor needs, and applying innovations.
• Develop strategies for trials and innovations for the execution of studies in collaboration with sponsors and internal teams.
• Harness data and clinical trial resources to deliver data-driven, patient-centered solutions for clinical development projects.
• Provide clinical and scientific input to CTI departments and collaborate on integrated trial strategies.
• Partner with regulatory to align plans, TPFs, regulatory submissions, and health authority interactions.
• Support award of strategic/new business by contributing to focused proposals and presenting at meetings.

Skills

Clinical leadership

Strategic thinking

Medical communication

Cross-functional collaboration

Negotiation & influence

Business acumen

Education

Medical degree from an accredited school

Board-certified physician in chosen area of medical specialization

Job description

CTI Clinical Trial Services Inc. seeks a Medical Director to lead medical strategy and oversee clinical development across awarded trials, with emphasis on cell and gene therapies.

The role drives cross-functional collaboration, ensures scientific rigor, and guides regulatory interactions to support sponsor objectives. The successful candidate will bring board-certified credentials, 3+ years in clinical development, and strong leadership.