Job Details

Kelly Science & Clinical is seeking a Director of Clinical Operations for a fulltime, Direct Hire role with a pharmaceutical client based in San Fran Bay area. If youre passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Base Salary Starts at: $190,000

Location: San Francisco Bay Area (Hybrid)

Schedule: M-F 8AM - 5PM

Job Title: Associate Director/Director of Clinical Operations

Job Summary: The Director of Clinical Operations will oversee the planning, execution, and management of our clinical trials, ensuring compliance with regulatory standards and alignment with corporate goals. This leadership role requires strategic thinking, operational excellence, and an ability to collaborate across function teams to advance our drug development pipeline.

Key Responsibilities:

• Lead and manage all aspects of clinical trial operations, including timelines, budgets, resources, and deliverables.
• Develop and implement clinical strategies to optimize trial efficiency and success.
• Ensure compliance with applicable regulations, guidelines, and best practices in all clinical activities.
• Collaborate with cross-functional teams (e.g., Regulatory Affairs, Data Management, Biostatistics) to ensure seamless execution of clinical trials.
• Foster relationships with key stakeholders, including investigators, sites, regulatory agencies, and vendors.
• Provide mentorship and leadership to clinical operations team members, fostering a culture of continuous improvement and professional growth.
• Proactively identify operational risks and implement appropriate mitigation strategies.
• Report trial progress and outcomes to senior management and other stakeholders.
• Up to 40% U.S. and international travel between clinical sites

Qualifications:

• BS/MS/PhD in Biology, Biochemistry, or Pharmacology or related degree
• Minimum five years of experience within the pharmaceutical or biotechnology industry in the U.S.
• Proven leadership experience with a track record of successful management of phase II-III clinical trials.
• Deep understanding of GCP, FDA regulations, and ICH guidelines.
• Strong strategic, analytical, and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Preferred knowledge and experience in infectious diseases

Travel

• Valid passport: Candidates must possess a valid passport with the ability to maintain its validity throughout the duration of employment.
• Experience with international travel is preferred.