Posted in General Business 30+ days ago.
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
The Clinical Supplies Manager oversees all aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal and external supply partners/vendors to ensure supply of IMP are sufficient at depots and clinical sites.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Lead effort for clinical supply management functionality.
• Monitor and manage clinical supply activities through IRT from study start-up through study closure.
• Proactively drive the labeling, packaging, release, distribution of clinical supplies at external CMO's for assigned studies, ensuring the project timeline is met or exceeded.
• Ensure domestic and global distribution arrangements are in place with external vendors to allow shipment following availability of technical and regulatory releases.
• In collaboration with relevant partners, create forecasts and packaging design based on study needs to ensure optimized supply plan.
• Partner with key stakeholders (including Quality Assurance and Regulatory Affairs) to ensure supplies are labelled and released for clinical site shipment for global clinical trials.
• Work cross-functionally to develop IRT to develop specifications and perform UAT.
• Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
• Represent clinical supplies function at clinical trial team meetings; communicate plan and timelines to internal and external customers and partners.
• Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors.
• Ensure appropriate system documentation is transferred to TMF and ready for inspection readiness.
• Utilize appropriate software and IT systems to effectively manage key project activities.
• No supervisory responsibilities
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
• BS/BA degree in related discipline and a minimum of five years of related experience; or,
• MS/MA degree in related discipline and a minimum of three years of related experience; or,
• Equivalent combination of education and experience.
• Certification in assigned areas is a plus.
• Experience with clinical supply management planning, labeling, packaging, and distribution.
• Clinical Supply management experience using contract manufacturing companies strongly preferred.
• Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS
• Willingness to work in a fast paced, evolving environment.
• Knowledge of GMP batch record development, review, and approval processes.
• Knowledge of Interactive Voice/Web response systems for use in clinical studies.
• Working knowledge of regulations relating to clinical labeling, packaging and distribution activities.
• Working knowledge of GMP/GCP/GLP regulations required.
• Excellent project management and communication skills.
• Environment: primarily working indoors in an office environment
The preceding job description has been designed to indicate 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 the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
30+ days ago
about 2 hours ago
about 2 hours ago
less than a minute ago
less than a minute ago
2 minutes ago
The Andersons Inc