BioSpace, Inc.
Associate Director, CMC Clinical Drug Supply & Logistics
BioSpace, Inc., South San Francisco, California, us, 94083
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 humanresources@ideayabio.com. 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 www.ideayabio.com.
Location: South San Francisco
Position Summary: We are seeking an experienced and highly motivated Associate Director, Clinical Drug Supply & Logistics to join our multidisciplinary team based in South San Francisco. The role requires the candidate to work collaboratively with the related cross-functional teams to support our drug development 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.
Reports to: Senior Vice President, Technical Operations
Job Description
What you'll do: Manage investigational product supply planning/forecasting for multiple domestic and global clinical trials 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 third-party 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 country requirements, review of executed labeling batch records, overseeing release Liaise with QA and other 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 supply-related 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 Follow-up 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 supply-related 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 Ensure activities are performed on time and with good quality, in compliance with Regulatory Authorities' regulations / guidelines andIDEAYA's policies. 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 7 years of clinical drug supply management experience demonstrating a progressively increasing scope of responsibility. Experience in leading cross-functional 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 drug 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 problem-solving skills and ability to quickly adapt and shift focus as needed 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 Associate Director, CMC Clinical Drug Supply & Logistics is $192,000 - $237,000. 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 http://www.ideayabio.com/ Phone 650-443-6209 Location 7000 Shoreline Court Suite 350 South San Francisco California 94080 US
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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 humanresources@ideayabio.com. 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 www.ideayabio.com.
Location: South San Francisco
Position Summary: We are seeking an experienced and highly motivated Associate Director, Clinical Drug Supply & Logistics to join our multidisciplinary team based in South San Francisco. The role requires the candidate to work collaboratively with the related cross-functional teams to support our drug development 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.
Reports to: Senior Vice President, Technical Operations
Job Description
What you'll do: Manage investigational product supply planning/forecasting for multiple domestic and global clinical trials 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 third-party 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 country requirements, review of executed labeling batch records, overseeing release Liaise with QA and other 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 supply-related 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 Follow-up 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 supply-related 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 Ensure activities are performed on time and with good quality, in compliance with Regulatory Authorities' regulations / guidelines andIDEAYA's policies. 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 7 years of clinical drug supply management experience demonstrating a progressively increasing scope of responsibility. Experience in leading cross-functional 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 drug 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 problem-solving skills and ability to quickly adapt and shift focus as needed 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 Associate Director, CMC Clinical Drug Supply & Logistics is $192,000 - $237,000. 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 http://www.ideayabio.com/ Phone 650-443-6209 Location 7000 Shoreline Court Suite 350 South San Francisco California 94080 US
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