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Associate Director/Director, Clinical Operations

Company: CytomX Therapeutics
Location: South San Francisco
Posted on: June 7, 2021

Job Description:

About CytomX Therapeutics:

CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX has a broad pipeline, including 4 clinical-stage programs and others in development and is located in South San Francisco, California, the birthplace of biotechnology. Learn more at www.cytomX.com.

Location: South San Francisco, California

Reporting into the Exec/Sr Director of Clinical Operations

The Opportunity:

the Associate Director/Director, Clinical Operations will be contributing to the development and implementation of strategic direction in the conduct of one or more clinical studies. Responsibilities include providing oversight of staff and studies to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements, and leading and directing Clinical Operations teams in the management of contract research organizations (CROs) and other trial vendors. Oncology experience is preferred. The Associate Director/Director will contribute Clinical Operations expertise in cross-functional meetings and initiatives. Management and mentoring of junior Clinical Operations staff is expected.

Professional Responsibilities (may change/update based on business need):

  • Accountable for overall management of one or more clinical trials including:
  • Providing strategic direction to study teams to meet corporate goals and timelines;
  • Oversight of CRO/vendor budgets and contracts
  • Reporting and justification of study metrics to Management Team, as requested

  • Contributes expertise in all operational activities pertaining to the execution of clinical trials
  • Partners with and maintains regular contact with relevant departments such as Regulatory Affairs (RA), Biometrics and Clinical Development, Legal, Finance, Outsourcing, and others as required
  • Participates in the selection of Contract Research Organizations (CROs)
  • May attend CRO or other vendor meetings such as project kick-off and investigator meetings, face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
  • Provides consistent, regular Sponsor oversight of CRO and vendor performance
  • In partnership with the Clinical Operations team contributes to definition, development and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices
  • Contributing member of various study and program teams
  • Contributes to the development of staffing/resourcing plans/mentoring of junior personnel as needed
  • Contributes to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed
  • Participate in Inspection Readiness efforts and in preparation for regulatory submissions
  • Travel may be required up to 20% in support of clinical study activities

Education/Experience:

  • BS/BA or MS/MA degree preferred in related discipline or equivalent combination of education and experience
  • Typically requires a minimum of 8-10 years of related experience or a minimum of 12 years combined education/training and experience.
  • Proven track record as a leader in clinical trials in the biotech, CRO or pharmaceutical industry.
  • Management experience including outsourcing to Contract Research Organizations (CROs) and running an internally resourced study.

Professional Requirements:

  • Has extensive experience in relevant industry/profession
  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
  • Develops technical and/or business solutions to complex problems
  • Identifies and applies advanced practices, technical principles, theories and/or concepts, and contributes to the development of new principles and concepts; has a comprehensive understanding of current approaches in industry and ability to incorporate them into CytomX' s programs
  • Guides the successful completion of major programs, projects and/or functions
  • Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing
  • Independently interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company
  • Works to influence the development departmental policies and oversees and/or authorizes their implementation.
  • Applies strong analytical and business communication skills

Personal Characteristics:

  • Demonstrate a commitment to CytomX values of Integrity, Commitment, Creativity, Teamwork, Accountability, and Fun

CytomX is an equal opportunity employer. Employment decisions are based on merit and business needs. CytomX will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.

Keywords: CytomX Therapeutics, South San Francisco , Associate Director/Director, Clinical Operations, Other , South San Francisco, California

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