Director, Clinical Operations

Day One Biopharmaceuticals

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 06/01/2021
  • Website: dayonebio.net
  • Company Address: , South San Francisco, California

About Day One Biopharmaceuticals

Cancer drug development comes of age.

Job Description

Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinical evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages.

 

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

                                                                                        

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

 

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.

Related Jobs

Clinical Trial Manager/Senior Manager

Day One Biopharmaceuticals - South San Francisco, CA, US

Research Operations Specialist

Day One Biopharmaceuticals - South San Francisco, CA, US

Associate Director/Director Drug Metabolism and Pharmacokinetic (DMPK)

Day One Biopharmaceuticals - South San Francisco, CA, US

Director, Clinical Operations

Day One Biopharmaceuticals - South San Francisco, CA, US

Head of Biometrics

Day One Biopharmaceuticals - South San Francisco, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.