BioSpace
Vice President or Senior Vice President, Clinical and Commercial Supply Chain
BioSpace, South San Francisco, California, us, 94083
Vice President or Senior Vice President, Clinical and Commercial Supply Chain
Join to apply for the Vice President or Senior Vice President, Clinical and Commercial Supply Chain role at BioSpace.
IDEAYA Biosciences is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. We integrate 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.
Location: South San Francisco, CA.
Position Summary IDEAYA Biosciences seeks an experienced Vice President or Senior Vice President, Clinical and Commercial Drug Supply to lead the company’s operations and strategies to ensure clinical and commercial drug supply. This individual brings 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. The role will be integral in IDEAYA’s transition to a commercial‑stage biotechnology company and will focus on the U.S. commercial manufacturing launch readiness of our lead program, Darovasertib in Uveal Melanoma (UM), and continued support of 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 the office a minimum of 4 days a week.
Job Description What you’ll do
Develop and own the global supply strategy for clinical and commercial phases — including demand forecasting, capacity planning, buffer stocks, and supply continuity.
Define and implement a Sales & Operations Planning (S&OP) process aligned with commercial, finance, regulatory and manufacturing functions.
Assess and manage supply risk (e.g., supplier capacity constraints, regulatory delays, geo‑risks) and build risk mitigation plans (dual sourcing, safety stocks, alternate routes).
Oversee supply of investigational products (IPs) for clinical trials, including packaging, labeling, distribution, and returns.
Lead technology transfers (from clinical to commercial) and scale‑up from pilot to commercial processes, ensuring continuity.
Work with external CDMOs and logistics/3PL partners to ensure timely supply for trials and launches.
Manage commercial‑scale manufacturing supply chains, packaging, serialization, warehousing and distribution; manage people reporting to this position for clinical and commercial supply and program management.
Ensure readiness for product launch: validation, qualification, capacity ramp, regulatory compliance (serialization, track & trace, import/export).
Oversee inventory management, allocation, demand‑supply balancing, replenishment and trade compliance.
Select, contract, qualify, and manage performance of CDMOs, CMOs, packaging, testing and logistics vendors.
Oversee adherence to service‑level agreements (SLAs), quality metrics, audits and change‑control management.
Collaborate and partner with cross‑functional teams (CMC, Regulatory, Quality, Manufacturing, Commercial, Finance, Legal, Project Management) to align supply with product strategy.
Serve as a member of the program or portfolio leadership team; provide executive‑level updates and risk escalations.
Lead the supply organization: hiring, mentoring, performance management and capability building.
Drive process improvement, system upgrades (e.g., ERP, supply‑chain digitalization), metrics/KPIs and continuous optimization.
Ensure operations comply with GMP, GDP, global import/export regulation, serialization & traceability and regulatory requirements.
Lead or support regulatory submissions related to manufacturing, supply, serialization and drug product changes (e.g., in CMC sections).
Prepare for and manage regulatory audits or inspections relevant to drug supply and logistics.
Responsible for updating the CEO, executive leadership team and the board of directors on a regular basis on the overall strategy and deliverables related to the clinical and commercial supply chain.
Requirements
Advanced Degree (Ph.D. preferred) in life sciences, chemistry, pharmaceutical sciences, engineering, pharmacy, chemical engineering or related field.
Minimum 20+ years’ experience in the biotechnology and pharmaceutical industry, with extensive experience in pharmaceutical/biotech operations, including clinical and commercial supply. Proven track record in successfully transitioning products from clinical to commercial stage.
Demonstrated experience in supply‑chain management, CDMO/CMO oversight, technology transfers, vendor management, logistics and serialization.
Technical expertise, deep understanding and strategic mindset of GMP regulations, quality systems and global supply‑chain management. Strong understanding of CFR Parts 58, 210, 211; ICH; and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications is required.
Commercial‑stage subject‑matter expertise and strong leadership presence as a commercial‑stage technical operations expert, driving continuous improvement initiatives and adeptly tackling complex commercial‑stage 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).
Total Rewards IDEAYA offers a competitive total rewards package that reflects its pay‑for‑performance philosophy. 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). The comprehensive benefits package includes medical/dental/vision coverage (100 % company paid for employees and 90 % company paid for dependents), 401(k), ESPP and wellness programs.
The expected salary range for the role of Vice President is $299,000 – $370,000 and Senior Vice President is $337,000 – $417,000. Final compensation will depend on factors such as office location, candidate experience, disease‑area expertise, education, performance during the interview process and company policy.
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.
All employees must be fully vaccinated against COVID‑19, with rare exceptions for medical or religious reasons, unless otherwise required by applicable law.
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IDEAYA Biosciences is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. We integrate 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.
Location: South San Francisco, CA.
Position Summary IDEAYA Biosciences seeks an experienced Vice President or Senior Vice President, Clinical and Commercial Drug Supply to lead the company’s operations and strategies to ensure clinical and commercial drug supply. This individual brings 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. The role will be integral in IDEAYA’s transition to a commercial‑stage biotechnology company and will focus on the U.S. commercial manufacturing launch readiness of our lead program, Darovasertib in Uveal Melanoma (UM), and continued support of 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 the office a minimum of 4 days a week.
Job Description What you’ll do
Develop and own the global supply strategy for clinical and commercial phases — including demand forecasting, capacity planning, buffer stocks, and supply continuity.
Define and implement a Sales & Operations Planning (S&OP) process aligned with commercial, finance, regulatory and manufacturing functions.
Assess and manage supply risk (e.g., supplier capacity constraints, regulatory delays, geo‑risks) and build risk mitigation plans (dual sourcing, safety stocks, alternate routes).
Oversee supply of investigational products (IPs) for clinical trials, including packaging, labeling, distribution, and returns.
Lead technology transfers (from clinical to commercial) and scale‑up from pilot to commercial processes, ensuring continuity.
Work with external CDMOs and logistics/3PL partners to ensure timely supply for trials and launches.
Manage commercial‑scale manufacturing supply chains, packaging, serialization, warehousing and distribution; manage people reporting to this position for clinical and commercial supply and program management.
Ensure readiness for product launch: validation, qualification, capacity ramp, regulatory compliance (serialization, track & trace, import/export).
Oversee inventory management, allocation, demand‑supply balancing, replenishment and trade compliance.
Select, contract, qualify, and manage performance of CDMOs, CMOs, packaging, testing and logistics vendors.
Oversee adherence to service‑level agreements (SLAs), quality metrics, audits and change‑control management.
Collaborate and partner with cross‑functional teams (CMC, Regulatory, Quality, Manufacturing, Commercial, Finance, Legal, Project Management) to align supply with product strategy.
Serve as a member of the program or portfolio leadership team; provide executive‑level updates and risk escalations.
Lead the supply organization: hiring, mentoring, performance management and capability building.
Drive process improvement, system upgrades (e.g., ERP, supply‑chain digitalization), metrics/KPIs and continuous optimization.
Ensure operations comply with GMP, GDP, global import/export regulation, serialization & traceability and regulatory requirements.
Lead or support regulatory submissions related to manufacturing, supply, serialization and drug product changes (e.g., in CMC sections).
Prepare for and manage regulatory audits or inspections relevant to drug supply and logistics.
Responsible for updating the CEO, executive leadership team and the board of directors on a regular basis on the overall strategy and deliverables related to the clinical and commercial supply chain.
Requirements
Advanced Degree (Ph.D. preferred) in life sciences, chemistry, pharmaceutical sciences, engineering, pharmacy, chemical engineering or related field.
Minimum 20+ years’ experience in the biotechnology and pharmaceutical industry, with extensive experience in pharmaceutical/biotech operations, including clinical and commercial supply. Proven track record in successfully transitioning products from clinical to commercial stage.
Demonstrated experience in supply‑chain management, CDMO/CMO oversight, technology transfers, vendor management, logistics and serialization.
Technical expertise, deep understanding and strategic mindset of GMP regulations, quality systems and global supply‑chain management. Strong understanding of CFR Parts 58, 210, 211; ICH; and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications is required.
Commercial‑stage subject‑matter expertise and strong leadership presence as a commercial‑stage technical operations expert, driving continuous improvement initiatives and adeptly tackling complex commercial‑stage 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).
Total Rewards IDEAYA offers a competitive total rewards package that reflects its pay‑for‑performance philosophy. 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). The comprehensive benefits package includes medical/dental/vision coverage (100 % company paid for employees and 90 % company paid for dependents), 401(k), ESPP and wellness programs.
The expected salary range for the role of Vice President is $299,000 – $370,000 and Senior Vice President is $337,000 – $417,000. Final compensation will depend on factors such as office location, candidate experience, disease‑area expertise, education, performance during the interview process and company policy.
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.
All employees must be fully vaccinated against COVID‑19, with rare exceptions for medical or religious reasons, unless otherwise required by applicable law.
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