- Provide oversight and leadership, therapeutic expertise, and guidance on one or more Study Execution Team(s) (SET) to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures, FDA regulations and ICH/GCP guidelines
- Extensive experience in evaluating and managing CROs/vendors; serve as point of escalation including program representative for vendor oversight and governance meetings
- Accountable for program oversight including identification and mitigation of risks to study implementation, enrollment, quality oversight and study completion
- Command of program status and proactively communicate issues or changes that may impact quality, timelines and costs to senior management and key stakeholders
- Partner with cross functional stakeholders to identify and remove executional barriers in order to ensure timelines and goals are met
- Represent Clinical Operations at Clinical Development Execution Team (CDET) and Project team and collaborate on developing the Clinical Development Plans and operational strategy (e.g., site selection, enrollment, data collection, monitoring) and accomplishing high-quality data deliverables
- Represent IDEAYA on program level partner clinical trial collaborations, as needed
- Develop and maintain strong relationships with internal cross-functional teams, CROs, and clinical research site personnel to ensure effective execution of clinical trials
- Develop, implement, and provide oversight of vendor budgets and contracts; may lead RFP and vendor selection including serving as the subject matter expert on budget negotiations
- Plan and implement quality checks for multiple clinical trials (e.g., establish and review key performance indicators, metrics and progress reports, identify barriers to timely and successful trial execution)
- Provide technical expertise for the development of clinical documents (e.g., protocols, informed consents and safety)
- Drive and support development of work instructions and SOPs; lead Clinical Operations functional initiatives and provide support to Cross Functional initiatives
- Resourcing and hiring: Coach and mentor direct and indirect reports while managing talent with succession planning in mind. Identify, recruit, hire, and develop Clinical Operations staff.
- Willing to travel domestically and internationally, as required
- Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree in a relevant scientific discipline is preferred
- A minimum of 12 years of experience with expertise in the areas of clinical operations with 8+ years of leadership experience including planning, implementing, and conducting early to late-stage oncology clinical trials
- 4+ years of direct line management experience
- Experience working within a small biotech company preferred
- Proven experience in developing high performance clinical operations group; setting expectations, creating accountabilities, and leading the team to successfully achieve its objectives
- Strategic ability with forward thinking that effectively translates to a clear sense of direction for teams is essential
- High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
- Excellent leadership and project management skills with ability to oversee multiple projects, complex timelines and shift priorities quickly while working under tight deadlines in a team environment
- Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
- Successful track record in study planning, execution, data cleaning, database locking, study report generation and regulatory inspections
- Therapeutic experience in global oncology clinical trials is highly desirable with experience in early and late phase drug development
- Results-oriented team player capable of working collaboratively with colleagues while building strong relationships
- Must be self-motivated, able to evaluate and resolve complex problems, and adaptable to a dynamic fast-paced environment
- Expertise in quality and GCP requirements to ensure the organization remains compliant with ICH GCP and other global regulatory guidelines or laws
- Able to problem solve, delegate appropriate tasks and/or develop junior team members as part of succession planning
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Director, Clinical Operations - South San Francisco, United States - BioSpace
Description
Job DetailsIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality - which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.
When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see .
Position Summary:
IDEAYA is seeking a talented, experienced Director of Clinical Operations with a passion for new cancer therapy development. This individual will be accountable for providing strategic operational leadership including expertise and oversight over 1 or more clinical program(s) driving financial planning/forecasting, resource and budget planning and management, and development and implementation of department initiatives. The ideal candidate will enjoy collaborating with an open, multi-disciplinary team in a fast-paced environment. This individual will independently plan and lead programs, direct reports and cross functional teams, in order to ensure individual, program, departmental and corporate goals and objectives are executed on time with quality and within budget in compliance with SOPs applicable regulations, and ICH/GCP guidelines.
What you'll do:
The salary range is an estimate and may vary based on the Company's compensation practices.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Benefits
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.
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