Vice President, Early Development Clinical Operations
Description:
Job Details
Non-Solicitation Policy and Notice to Agencies and Recruiters:
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to . We ask that you only email your interest once.
Job Summary
About IDEAYA Biosciences:
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
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
Location: South San Francisco
Position Summary:
We are seeking a dynamic and experienced Vice President of Early Development Clinical Operations. This individual will be responsible for leading and executing the clinical operations strategy within early clinical development. The ideal candidate will possess a deep understanding of and demonstrated track record for execution of early stage clinical operations programs, as well as a proven leadership track record as a strong collaborator with late stage colleagues to ensure seamless transition of programs from early to late stage. This position reports to the Chief Medical Officer.
This role is based in IDEAYA's South San Francisco, California office with an expectation to be in the office 4 days a week.
Job Description
What you'll do:
Provide leadership, therapeutic expertise and guidance on early development clinical operations activities to ensure quality, resource, budget and timeline goals are met.
Collaborate with Medical Directors/Clinical leaders and the project teams on developing the clinical operational strategy and accomplishing high-quality data deliverables.
Set clinical operations vision within early clinical development including expectations for the team, clarifying accountabilities and leading team to achieving its goals.
Establish performance indicators to ensure the successful execution of clinical trial deliverables.
Represent early development clinical operations and provide updates to the program team and executive leadership.
Plan and implement quality checks for clinical projects; provide leadership and direction to ensure the highest standards for compliance with pharmaceutical regulatory requirements; develop a pro-active approach for inspection readiness.
Contribute to the development of INDs, protocols, informed consents and other clinical / regulatory / safety documents.
Develop and maintain strong relationships with internal cross-functional teams, CROs, and clinical research site personnel to ensure effective execution of clinical trials.
May function as executive sponsor for preferred vendor/CRO relationships.
Recruit, hire, mentor, and manage direct reports as required and support their professional development.
Initiate and lead departmental or interdepartmental strategic initiatives to further strengthen the organization.
Requirements:
Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree in a relevant scientific discipline is preferred.
A minimum of 15 years of experience working in the biotech/pharmaceutical industry in the Clinical Operations function
A minimum of 10 years of in the oncology therapeutic area with proven expertise in early development clinical operations setting strategy, planning, implementing, and conducting early phase clinical trials.
A minimum of 10 years of people management experience.
Small, mid-size,and large company clinical operations experience required. Direct relevant experience leading this function within a small to mid-size pre-commercial stage biotech company is desired.
Proven leadership in developing a high-performance clinical operations group; setting expectations, creating accountabilities, and leading the team to successfully achieve its objectives with strict adherence to program timelines.
Ability and willingness to perform in IDEAYA's working-leader environment where all leaders are expected to demonstrate strategic leadership, role modeling our company values, demonstrating collaboration and teamwork, and rolling up your sleeves on day-to-day deliverables is a requirement
Excellent interpersonal, communication and presentation skills.
Ability to influence across a multi-disciplinary team and create a clear sense of direction.
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 oncology clinical trials is highly desirable with experience in early phase drug development.
Results-oriented team player capable of working collaboratively with colleagues while building strong relationships.
Ability to evaluate and resolve complex problems in a dynamic environment.
Expertise in CRO & vendor management.
Expertise in quality and GCP requirements to ensure the organization remains compliant.
Experience with ICH GCP and other global regulatory guidelines or laws.
Total Rewards
Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.
The expected salary range for the roleof Vice President Early Development
Clinical Operations is $302,000- $373,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.
The Company complies with all laws respecting equal employment opportunities 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 in the office at the Company's facilities for training & meetings, with 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.
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.
Company
Founded in 2015, IDEAYA Biosciences is a public, clinical-stage synthetic lethality-focused 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.
Stock Symbol: IDYA
Company info
Website Phone Location 7000 Shoreline Court
Suite 350
South San Francisco
California
94080
US
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