Senior Director, Good Clinical Practice & Good Pharmacovigilance Practice Quality Assurance
Apply NowCompany: BioSpace
Location: South San Francisco, CA 94080
Description:
Job Details
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. 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 have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as 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 established strategic collaborations with GSK, Merck, Pfizer, and Gilead but wholly-owns or controls its four most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.
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 teamwork to move science forward. For more information, please see www.ideayabio.com .
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com
Position Summary:
The Sr. Director of GCP & GVP QA is a senior leadership role responsible for overseeing the quality assurance activities related to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP),Good Clinical Laboratory Practice (GCLP),. This role is responsible for ensuring compliance with global regulatory requirements, industry standards, and company policies related to clinical trials. The candidate will lead a team of QA professionals, provide strategic leadership, drive continuous improvement initiatives, accountable for quality oversight of contract organizations, and ensure the highest standards of quality and patient safety in clinical research activities. The candidate will represent QA and function as the GCP & GVP QA lead and accountable for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP),Good Clinical Laboratory Practice (GCLP)oversight for all Ideaya Bio. clinical studies. This position will report to the Vice President, of QA.
This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
What you'll do:
Requirements:
Preferred Skills:
$228,098 - $281,768 a year
At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco, California office is $228,098 - $281,768 .
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 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.
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.
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.
California Job Applicant Privacy Notice
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. 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 have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as 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 established strategic collaborations with GSK, Merck, Pfizer, and Gilead but wholly-owns or controls its four most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.
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 teamwork to move science forward. For more information, please see www.ideayabio.com .
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com
Position Summary:
The Sr. Director of GCP & GVP QA is a senior leadership role responsible for overseeing the quality assurance activities related to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP),Good Clinical Laboratory Practice (GCLP),. This role is responsible for ensuring compliance with global regulatory requirements, industry standards, and company policies related to clinical trials. The candidate will lead a team of QA professionals, provide strategic leadership, drive continuous improvement initiatives, accountable for quality oversight of contract organizations, and ensure the highest standards of quality and patient safety in clinical research activities. The candidate will represent QA and function as the GCP & GVP QA lead and accountable for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP),Good Clinical Laboratory Practice (GCLP)oversight for all Ideaya Bio. clinical studies. This position will report to the Vice President, of QA.
This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
What you'll do:
- Develop and implement the global GCP QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements.
- Function as the Clinical QA Lead on all Ideaya Clinical study, represent QA in joint and steering committees including making key decisions on all GCP events.
- Oversee the development, implementation, and maintenance of GCP QA policies, procedures, and systems.
- Support the development and review of clinical trial protocols, informed consent forms, and other critical study related documents.
- Review and approve key documents, study protocol, monitoring plans, contracts and all study related essential documents.
- Ensure Ideaya clinical studies are in compliance with global GCP regulations (e.g., FDA, EMA, ICH E6 R2/R3) and company standards.
- Compile, track GCP quality metrics (KPI) and vendor performance on all Ideaya initiated clinical studies and report to management on a quarterly basis.
- Lead and manage GCP audits, including clinical investigator sites, vendors, clinical trial documentation, and internal processes.
- Host and support regulatory inspections (i.e., BIMO, PV), partner audits and due diligence activities ensuring inspection readiness and timely resolution of findings.
- Review and approve audit reports, CAPA and quality action plans, and follow-up actions to ensure effective resolution of non-conformance and quality events.
- Identify, assess, and mitigate GLP/GCP-related compliance risks across clinical development programs including escalation of critical quality events to sr. management.
- Collaborate with clinical operations, regulatory affairs, and other stakeholders to address quality events and drive continuous improvement.
- Partner with clinical development, regulatory affairs, pharmacovigilance, and other functions to ensure alignment on quality and compliance objectives.
- Partner with clinical operations in selection of CRO's and other clinical service providers including managing the qualification and ongoing monitoring of GCP vendors, including CROs, central labs, and clinical service providers.
- Ensure contract research vendor compliance with contractual obligations, agreements, and regulatory requirements.
- Build, mentor, and lead a high-performing GCP QA team. Provide training and development opportunities to enhance team capabilities.
- Foster a culture of quality, accountability, and collaboration within the team and across the organization.
- Provide expert guidance on GCP regulations, guidance and compliance to senior management and cross-functional teams.
Requirements:
- Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred).
- Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with at least 10 years' experience working in GCP QA or clinical quality leadership roles.
- Minimum of 5+ years' experience hosting regulatory BIMO inspections (e.g., FDA, EMA, PMDA) and managing GCP audit programs.
- Proven track record and relevant industry experience in leading GCP QA functions within a global organization, preferably in oncology.
- Strong knowledge of global GCP regulations, ICH guidelines, and clinical trial processes.
- Excellent leadership, communication, team building and people skills, with the ability to influence stakeholders at all levels.
- Analytical thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for audits, inspections, and meetings.
- Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
- Must be able to effectively collaborate with peers and comfortable working in a matrix team structure
Preferred Skills:
- Preferred background of oncology and/or early phase R&D
$228,098 - $281,768 a year
At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco, California office is $228,098 - $281,768 .
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 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.
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.
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.
California Job Applicant Privacy Notice