Philadelphia, PA

Director of Clinical Operations

My biotech client is a clinical stage cell therapy company and seeks a Director of Clinical Operations to lead phase one and later clinical trials.

 

Director of Clinical Operations

 

Key responsibilities:

  1. Direct clinical studies and collaborate with cross-functional teams to ensure the integration of clinical trial activities with overall objectives.
  2. Oversee the study-specific CROs, vendors, and contractors and assist with preparing clinical protocols, case report forms, study manuals, and other relevant clinical documentation.
  3. Work closely with CROs to establish systems including safety management, data management, clinical monitoring, and TMF.
  4. Partner with financial leadership and ensure that study budgets stay on track.
  5. Establish and lead study management team meetings internally and with study vendors.
  6. Engage and influence internal and external collaborators across multifunctional teams while prioritizing multiple projects and meeting deadlines.
 

Essential Qualifications:

  • BS/BA degree in scientific field, with advanced degree preferred.
  • Exceptional team player with desire and ability to fill functional gaps in a small biotech firm.
  • Excellent project management, communication, and interpersonal skills.
  • Ability to influence team members, prioritize projects, and meet deadlines.
  • Proven ability to effectively handle multiple priorities in a fast-paced environment.

 

Preferred Experience:

  • Proven leadership in planning and managing cell therapy trials.
  • 8+ years clinical operations experience in biotech/pharma including 4+ years as manager and higher.
  • CRO and vendor oversight, success in executing early phase trials, and leadership within a small biotech firm are all desired.
  • Working knowledge of GCP/ICH guidelines and the clinical development process.
  • Strong leadership and team-building skills, with the ability to inspire and motivate a diverse group of professionals.

 

Additional Points:

 

--This is a full time, hybrid position based in the Philadelphia area.

--Title and salary (including base, bonus, and options) are commensurate with experience.

 

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