Director, Clinical Operations

Location
South San Francisco, CA
Posted
Jul 14, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

JOB TITLE: Senior/Director, Clinical Operations         LOCATION: San Francisco

DIVISION: Product Development                                 DEPARTMENT: Clinical Operations

REPORTS TO: VP, Clinical Operations

 

Day One was founded to address a critical unmet need: children with cancer are being left behind in a cancer drug development revolution. Our name was inspired by the “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. We aim to re-envision cancer drug development and redefine what’s possible for all people living with cancer—regardless of age—starting from Day One.

SUMMARY: 

The Sr/Director, Clinical Operations is accountable for the Phase I-III trials oversight within a program or therapeutic indication, and reports to the Vice President, Clinical Operations.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Ensures multiple Ph I-III clinical trials are executed within designated program budgets and timelines
  • Collaborates with cross functional colleagues to ensure timely delivery of assigned studies
  • Provides departmental strategic input into applicable forums
  • Recruits, hires and manages Clinical Operations resources to ensure optimal deployment across trials or projects
  • Support Clinical Operations resources in their professional development
  • May initiate and lead departmental or interdepartmental strategic initiatives
  • Experienced in developing RFPs, selection of CROs/vendors, and management of external resources is required
  • Contributes to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents
  • May contribute to Clinical Operations SOPs and/or governance documents
  • May contribute to development of abstracts, presentations and manuscripts
  • Provides problem-solving expertise to clinical trials, and monitors trial key performance indicators in an effort to ensure timely execution of milestones
  • May attend qualification, initiation, interim monitoring, and close-out visits.
  • Ensures all trials are conducted in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices
  • Ensures all trials are conducted according to budget, including monthly and quarterly forecasting in partnership with Finance
  • Occasional domestic US travel up to 25%, and internationally (on an “as needed basis”) in support of trial activities
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    SUPERVISORY RESPONSIBILITIES:

    ·         Clinical Trial Specialists to Associate Directors

     

    EDUCATION/EXPERIENCE/SKILLS: 

    Education:

    ·       BS/BA degree in science-related discipline; or,

    ·       Advanced degree in related discipline; or,

    ·       Certification in assigned area

    Experience:

    ·       Typically requires a minimum of ten (10) years of related experience, contingent on education/training

  • Oncology experience is required

  • Knowledge/Skills/Abilities:

  • Extensive clinical operations knowledge and cross-functional understanding of global clinical trial methodology 
  • Exhibits ability to learn and apply foreign health authority regulations to the clinical trial/research process
  • Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
  • Knowledgeable in clinical database platforms, interactive response technology (IRT) applications and processes, and clinical supply logistics
  • Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally
  • Frequently applies strong analytical, business and communication skills, as well as technical standards, principles, theories, concepts and techniques
  • Authoritative command of dealing with complexity and ambiguity; ability to collect, digest and communicate information through relevant business analyses to influence decision-making
  • Ability to communicate vertically and horizontally through multiple channels, leverage contact network to motivate diverse teams, and enable cross-functional collaboration
  • Prior experience managing full-time and/or contract employees
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    JOB COMPLEXITY:

    ·       Works on assigned problems of complex scope with analysis of situation or data required

    ·       Exercises judgment within defined procedures and practices to determine appropriate action

    ·       Builds productive internal and external working relationships

    ·       Uses professional concepts and company’s policies and procedures to solve a variety of routine problems.

     

    DISCLAIMER

    The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.