Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Translational Development (TD) Operations department provides end-to-end biospecimen operations logistics and biospecimen management for Celgene-sponsored clinical trials involving Translational Development biomarkers. This is a manager level position in TD Operations with employee supervisory responsibilities and opportunities to manage develop and optimize department work streams cross-functionally.
Partner with Clinical Operations and Translational Development Scientists in generating well-defined and logistically feasible biomarker plans for study protocols with alignment to informed consent documents and case report forms.
Manage and oversee the compliance of clinical biospecimen management through tracking the receipt, distribution, storage, use, and destruction; manage informed consent and sample retention times via the Labmatrix biospecimen management system.
Manage knowledge base of R&D/clinical laboratory techniques for biospecimen processing and staying current on latest trends in biospecimen management.
Ensure development and delivery of high quality training/study materials (lab manuals, quick reference guides, videos) describing biomarker sample handling for use by site personnel conducting Celgene's global clinical trials.
Contribute to the development and maintenance of SOPs, WPs and guidance documents for the department.
Work with TD Operations director on gap analyses and opportunities for improvement in department's biospecimen management processes with an eye for the future state internally and externally.
Directly supervise and mentor TD Operations Specialists in biomarker logistics support with focus on biospecimen tracking and reconciliation and developing well-versed knowledge of R&D/clinical laboratory techniques that result in high performance.
Bachelor's degree in the life sciences or healthcare related field and at least 10 years industry experience in clinical trials and biospecimen management or Master's degree and at least 8 years experience. The ideal candidate will also have 3-5 years people management experience. Skills/Knowledge Required:
- Applied scientific background in hematology and/or oncology disease indications; knowledge of disease mechanisms and/or signaling pathways with proven ability to apply scientific and technical expertise to biomarker research in clinical trials in an industry setting.
- Sponsor-side clinical trial experience in handling multiple complex Ph1 clinical trials with emphasis on operational, regulatory and ethical aspects of biospecimen collection and banking.
- Extensive experience in managing a clinical trial biospecimen repository in an industry setting, with experience in building/working in biospecimen databases and working with vendor databases, IVR/EDC systems and clinical data listings to track, manage, cross-check and reconcile biospecimens. Experience with Labmatrix is a plus.
- Experience in developing biomarker sampling plans, working with biomarker data management plans and overseeing biospecimen logistics at vendors and academic institutions.
- Extensive laboratory experience in R&D/clinical laboratory techniques involving blood/biopsies.
- Proven abilities in setting priorities, managing multiple projects, building processes and implementing complex/novel strategies in managing biospecimens.
- Solid understanding of project management principles with proven ability to provide deliverables on time, manage timelines and provide issue resolution.
- Outstanding leadership, communication, team building and influencing skills with the ability to work in a multifunctional team environment, interact with a wide variety of internal and external customers and relate effectively to individuals at all levels of the organization.
- Previous supervisory experience of diverse teams required.
- Up to ~20% travel to Celgene corporate sites, CROs, investigator meetings or clinical sites required.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.