Head of Clinical Operations (CD21-275)

Location
South San Francisco, CA
Posted
May 26, 2021
Ref
CD21-275
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Catalyst Biosciences is seeking an accomplished individual to serve as the Head of Clinical Operations. The successful candidate will be a proven leader who will work closely with the company’s leadership team, company staff, and external partners to advance Catalyst Biosciences’ pipeline medicines, which are designed to significantly change the lives of patients with complement or coagulation system disorders.

The Head of Clinical Operations is a hands-on position with responsibilities for planning, oversight, and conduct of clinical trials in a manner consistent governing regulation and our corporate cultural values of competence, commitment, connection, and communication. This individual must have the ability to work in a highly creative and collaborative environment and will represent the company’s Clinical Operations’ mission of executing properly designed clinical studies within agreed upon budget and timelines.

ABOUT CATALYST BIOSCIENCES

Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet needs within bleeding and complement related disorders. Catalyst has compounds that span the value chain from the earliest discovery to late-stage clinical trials with the intent of commercialization.

We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late-stage clinical development. We expect you to bring an innovative mindset, scientific curiosity, a lot of energy and pragmatism. For more information, please visit www.catalystbiosciences.com.

Responsibilities:
  • Manage an internal Clinical Operations team with a goal of establishing a culture of excellence and creativity.
  • Develop, articulate, and gain alignment across the organization on the necessary Clinical Operations policies, processes, and procedures that support advancement of the company’s pipeline.
  • Contribute to strategic planning to ensure optimized clinical development plans.
  • Proactively partner with other functional departments and teams to energize and motivate the business to be flexible and adaptive in ways that optimize the ability to recognize and capture opportunities for increased effectiveness.
  • Establish and promote an environment of unparalleled quality and rigorous adherence to process and documentation to ensure successful product development.
  • Develop and manage clinical study budget and timelines and develop viable contingency/mitigation plans.
  • Coordinate closely with other functional departments to ensure open communication and alignment on activities associated with clinical study conduct.
  • Lead, manage, and ensure a state of inspection readiness on regulatory compliance matters relating to conduct of clinical studies.

**Title and level to commensurate with education and experience.

REQUIREMENTS
  • BA/BS degree with 10 plus years of building and managing a Clinical Operations function in biotechnology with an emphasis on an outsourcing model.

  • Comprehensive understanding of GCP, ICH, and clinical study regulations

  • Proven track record in building and managing a high performing Clinical Operations team

  • Must be a dynamic leader with outstanding communication skills and an ability to effectively direct subordinates.

  • Demonstrated strengths in problem solving, strategic planning, and working collaboratively.