Associate Director, Clinical Supply & Logistics

Who we are
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What youll be doing
The Associate Director, Clinical Supply and Logistics will have oversight of Preclinical Supplies (PS) and Clinical Trial Materials (CTM) management, providing inventory and supply management leadership for multiple preclinical and clinical programs. The incumbent will work with internal and external teams to develop PS and CTM supply chain strategy and ensure the effectiveness of the execution of research and development, including for global Phase I-IV clinical trials.

In accordance with Nuvation Bios outsourcing model for drug substance and drug product manufacturing, storage, and distribution, the incumbent will oversee the planning and execution of outsourced supply chain activities and will work proactively with external partners to define project scope, identify, and mitigate risk, and to ensure successful delivery regarding technical, quality, timeline and budget goals. The incumbent will contribute to building and maintaining excellent working relationships with Contract Manufacturing Organizations (CMOs) and will work within a cross-functional team environment to support Nuvation Bios senior leadership team in defining, and executing against, short-, intermediate- and long-term strategic goals.


You will be responsible for
Establish and lead Preclinical Supplies (PS) and clinical trial materials (CTM) supply chain strategy for the portfolio products in keeping with corporate and program objectives.

Proactively manage movement and storage of other materials to best support and facilitate business.

Effectively partner and collaborate with internal stakeholders in the areas of Clinical Operations, Clinical Development, Program Management, Drug Product, Quality, Regulatory, as well as external business partners.

Collaborate with Clinical Operations to forecast CTM requirements for each clinical trial. Manage CTM inventory to support clinical trials.

Collaborate with manufacturing operations to create manufacturing plans, as well as integrate into supply chain logistics, and distribution plans.,

Coordinate all aspects of CTM outsourcing activities. This may include contributions to vendor assessment and selection, contract negotiation, budget planning, and Contract Manufacturing Organizations (CMOs) oversight. This may include aspects of CTM packaging, labeling, shipping, and storage operations at CMOs, including assuring that relevant GMP documentation review and approval activities are carried out.

Manage CTM return, reconciliation, and destruction operations outsourcing, including tracking CTM inventories and expiry dates and coordinating import/export requirements.

Ensure well-organized, clear, and complete records of all activities across areas of responsibility.

Develop and maintain SOPs, policies, and guidance documents relevant to areas of responsibility.

All other duties as assigned


Requirements

What skills & experience youll bring to us

BS/BA in Science, Engineering, Logistics, Supply Chain Management, or a related field with a minimum of 10+ years of hands-on working experience in clinical trial material (CTM) management in the biopharmaceutical industry is required

Significant knowledge of and experience in managing CTM supply in multiple phases of development and for post-marketing studies

Demonstrated experience with relevant systems/software to track and manage CTM supply distribution and inventory

Extensive hands-on working experience with CMOs in CTM management

Hands-on working experience with the supply side of global IRT systems

Hands-on experience with supply of open-label and blinded studies, including global labeling and distribution requirements for IP, placebo, and comparator drugs

Familiarity with current regulatory requirements related to manufacturing small molecule drugs and CTMs.

Highly organized, exceptional attention to detail, and strong proficiency in documentation skills.

Must work well in team settings, with the ability to work independently and collaboratively.

Demonstrated ability to enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders.intermediate- and long-term strategic goals


What we have for you!

Competitive Base Salary, Bonus, and Equity Plans

Unlimited Vacation and 10 Sick Days Annually

Excellent Medical, Dental, and Vision Coverage

401K with Company Matching

and much more!

Disclaimer:
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts managements right to assign or reassign duties and responsibilities to this job at any time.
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.