Associate Director CMC Clinical Supply
Associate Director CMC Clinical Supply
Posted on :
06-04-2025
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1 Vacancy
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Monthly Salary
$ 169507 - 209391
Vacancy
1 Vacancy
Posted on :
06-04-2025
Job Description
IDEAYA Biosciences (NASDAQ: IDYA) is a public clinicalstage 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 whollyowns or controls its four mostadvanced clinical programs and we are committed to building a bestinindustry organization to deliver our precision medicines to the people who need them.
When youre 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 datadriven innovators who like to collaborate and use teamwork to move science forward. For more information please see www.ideayabio.
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
Position Summary:
We are seeking an experienced and highly motivated Associate Director Clinical Supply to join our multidisciplinary team based in South San Francisco. The role requires the candidate to work collaboratively with the related crossfunctional teams to support our drug discovery pipeline. The successful candidate will be responsible for but not limited to those listed below.
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 youll do:
- Manage supply planning/forecasting to ensure alignment with study activity and timelines
- Collaborate with the CMC and clinical team in developing CTM supply requirements planning based on forecasts
- Participate in relevant team meetings providing clinical supply status reports and support.
- Establish and document the supply chain for each project as applicable to the scope
- Vendor Management/Oversight as a point of contact for thirdparty packaging distribution and storage Vendors
- IRT (Interactive Response Technology) Systems design review specifications build perform user acceptance testing (UAT) deployment maintain monitor enhance systems
- Preparation of label text translations and proofs that align with county requirements review of executed labeling batch records overseeing release
- Liaise with appropriate parties to ensure timely review and approval of batch records for packaging and labeling per applicable regulations (Qualified Person Release Certificates of Analysis/Compliance etc.
- Collaborate with the study team and vendors to ensure proper distribution of clinical supplies to study sites
- Revise study specific Pharmacy Manuals and supplyrelated training/instructional materials based on protocol amendments
- Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid potential supply issues
- Followup on reported Temperature Excursions and/or Product Complaints from sites/depots
- Ensure expiry extensions are provided to depot/sites as needed to support continued use
- Serve as an escalation point for supplyrelated issues received from sites
- Provide and/or support documentation for global shipment of clinical supplies e.g. proformas and commercial invoice
- Filing appropriate documentation for IP supply activities in the Trial Master File
- Manage return and destruction of clinical supplies with proper documentation of all steps
Requirements:
- A minimum of a BS/BA in Supply Chain Management or related field. An equivalent combination of relevant education and applicable job experience may be considered.
- A minimum of 10 years of clinical supply management experience demonstrating a progressively increasing scope of responsibility.
- Experience in leading crossfunctional groups. Late phase and commercial experience are a plus.
- Must be an expert in GXP requirements and knowledgeable of industry service providers trends and challenges.
- A strong understanding of regulatory requirements impacting the clinical supply chain.
- Analytical skills with the ability to forecast and manage supply chain risks and inventory.
- Demonstrated knowledge and application of building and enhancing IRT systems.
- Experience with global comparator sourcing
- Knowledge of trade compliance and VAT reclamation
- Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs.
- Experience in managing international CMOs reviewing documentation and ensuring proper guidelines are followed.
- Exceptional problemsolving skills and ability to quickly adapt and shift focus as needed
$169507 $209391 a year
At IDEAYA Biosciences we care about our employees and strive to provide a marketcompetitive total rewards package including base pay an annual performance bonus company equity and generous health and wellbeing benefits. The expected salary range for this role that is based in our South San Francisco California office is $169507 $209391.
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 Companys facilities with partial workfromhome 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 COVID19 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 twodose COVID19 vaccine series or a singledose COVID19 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 payforperformance philosophy where employees are eligible to be considered for meritbased salary increases company discretionary shortterm 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.
Required Experience:
Director
Employment Type
Full-Time
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