What are the responsibilities and job description for the Senior Vice President, Technical Operations position at IDEAYA Biosciences?
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:
IDEAYA Biosciences is seeking an experienced Senior Vice President, Technical Operations, to lead and execute the company’s overarching technical operations and business strategies across all stages of drug development, manufacturing, and clinical and commercial supply. This individual will bring to IDEAYA a proven track record of success and deep expertise in leading large-scale external commercial manufacturing, supply chain functions, ensuring reliable product quality, regulatory compliance, and on-time global supply. As a member of the executive leadership team, this role will be integral in IDEAYA’s transition to a commercial stage biotechnology company and will have an initial focus on U.S. commercial manufacturing launch readiness of our lead program darovasertib in Uveal Melanoma (UM) and continue supporting the global launch plans and product life-cycle management.
This role reports to the Chief Executive Officer and is based in IDEAYA’s South San Francisco, California office, with an expectation to be in office 4 days a week.
\n- Develop and implement the company's overall technical and operational strategy, including technology roadmap, manufacturing processes, and quality control standards.
- Commercial Manufacturing Leadership. Build and execute the end-to-end commercial manufacturing strategy and tactics to include all supplier selection, technology transfer, and ongoing process optimization for both drug substance and drug product. Ensure GMP compliance, robust quality systems, and regulatory readiness to support commercial supply and global product launches.
- Collaborate with senior leadership to establish priorities, budgets, and timelines for product commercialization and life-cycle management.
- Commercial, Large-scale and Global Technical Operations Acumen. Apply your breadth and depth of technical operations acumen, experience and knowledge-- from chemistry, analytical, process R&D, through commercial and global manufacturing best practices to anticipate commercial launch readiness needs and to resolve technical challenges during our commercial transition and launch.
- Oversee the CMC function, strategy and team to ensure seamless execution of CMC from late-phase development through commercialization. Drive a focus on cross-functional team collaboration with stakeholders in research, development, quality, regulatory, and commercial to ensure seamless integration across all IDEAYA functions.
- Vendor and partner management of relationships with CMO’s and raw material suppliers, negotiating contracts, setting performance standards, and overseeing quality and timelines. Continuously evaluate the external network, identifying new partners and implementing improvements to enhance cost-effectiveness and supply reliability.
- Guide process scale-up, technology transfers, and troubleshooting activities to ensure product consistency and on-target performance
- Team Leadership - Build, mentor, and inspire a high-performing team, fostering a culture of collaboration, innovation, accountability, and continuous improvement.
- Advanced Degree (Ph.D. preferred) in Chemistry related sciences, e.g. Organic Synthetic Chemistry, Medicinal Chemistry, Analytical Chemistry, Pharmaceutical Sciences or Engineering, or related field
- Minimum 25 experience in the biotechnology and pharmaceutical industry, with a focus on small-molecule and antibody drug conjugate modalities, commercial manufacturing, and CMC leadership. Proven track record in successfully transitioning products from clinical to commercial scale.
- Technical expertise, deep understanding, and strategic mindset of GMP regulations, quality systems, and global supply chain management. A strong understanding of CFR Parts 58, 210, and 211; ICH; and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications is required
- Commercial-stage Subject Matter Expertise. Must display a strong leadership presence as a commercial-stage technical operations subject matter expert, driving continuous improvement initiatives and adeptly tackling complex commercial stage manufacturing and supply chain challenges.
- Regulatory acumen and direct experience with global regulatory filings, inspections, and compliance standards, including authoring and reviewing Module 3 documentation
- Essential leadership skills and proven success in building and leading technical operations, multidisciplinary teams, high-performing cross-functional teams, managing complex projects, highly collaborative, strong teamwork and interpersonal skills, demonstrated strength in influencing at all levels of the organization and in a matrixed environment to influence and galvanize cross-functional teams (internally and externally)
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 $338,555 - $418,215.
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.
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Salary : $338,555 - $418,215