Senior Manager, Biospecimen Operations IO
Other Locations:US- NJ- Summit East
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.
Biospecimen Operations provides end-to-end biospecimen operational logistics and management for Celgene-sponsored Phase 1-4 clinical trials and externally acquired biospecimens. This role will report to the Executive Director of Biospecimen Operations. The individual will be responsible for supporting biospecimen management for the Immuno-Oncology (IO) franchise with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.
Bachelor's Degree in life sciences or healthcare related field with 6 years of industry experience in clinical trials and/or biospecimen management or Master's Degree with 4 years of relevant experience in clinical trials and/or biospecimen management. Minimum of 3 years direct supervisory experience required.
Responsibilities will include, but are not limited to, the following:
- Support biospecimen operations within the Immuno-Oncology franchise which has an accelerated pace of upcoming trials
- Coordinate with Biospecimen Operations franchise leads in Hematology/Oncology and Inflammation & Immunology to create alignment in policies and procedures associated with the biospecimen operations group including end to end trial management, utilization and vendor management for biospecimens
- Develop and manage scientific and technical knowledge base of R&D/clinical laboratory techniques for biospecimen processing specific to the IO franchise and provide training and support to direct reports
- Either directly or by leading others, ensure biomarker processing and logistics are expertly represented at internal meetings, investigator meetings, site initiation visits, CRO management trainings/meetings, etc.
- Act as an escalation point for biospecimen operations team members to address informed consent and Institutional Review Board/Ethical Committee questions related to biospecimens for clinical studies
- Manage a group of specialists who oversee end to end trial management of IO biospecimens including
- Partnering with global Clinical Operations team members and Translational Development Scientists to generate logistically feasible biospecimen plans for study protocols
- Review of biospecimen-related clinical documents including clinical protocols, ICFs, CRFs and laboratory manuals for successful study start-up
- Deliver high quality training/study materials (lab manuals, quick reference guides, videos) for biospecimen processing and handling to clinical sites
- Manage internal timelines to ensure alignment with vendor and clinical study timelines, maintain open communication with vendors and resolve/escalate vendor issues
- Support procurement as needed in contracting with analytical lab vendors by providing scientifically-specific contracting language
- Define and manage project timelines and resource allocation on studies /programs
- Collaborate with Biospecimen Data Stewards to resolve biospecimen issues detected through data transfers; identify and mitigate study-specific risks with study team, sites, CROs, or vendors
- Manage specialists who oversee and execute processes in IO associated with
- Biospecimen utilization including internally and externally acquired biospecimens
- Management of biospecimen long-term vendor and external sources for biospecimen acquisition
- Management of informed consent language related to biospecimens collected in clinical studies
- Act as an escalation point for any study or portfolio level risks/issues as they pertain to biospecimen collection, management and/or destruction within the IO franchise
- Identify process flow gaps and make recommendations for improvement in biospecimen operations
- Evaluate and make recommendations in vendor selection and track/manage IO assay quality performance at biomarker laboratories; manage vendor(s) portfolio to assess biospecimen quality and provide input to Celgene preferred vendor list in the context of clinical studies
- Define and report on key metrics related to biospecimen management performance and capacity in IO
- Provide ongoing professional development to direct reports overseeing the biospecimen operations logistics for the IO franchise
- Assist Executive Director and other franchise leads within Biospecimen Operations with strategic planning, decision making, improving processes, seeking out development opportunities and driving new services.
- Stay current on the latest trends in biospecimen and consent management including participation in internal/external forums
- Lead internal and external initiatives as needed to support the mission of the franchise by staying current on the broader context of support, continually assess quality operations support and regularly identify gaps and propose/drive solutions especially in new areas for the franchise supported
- Experience managing clinical trials and biospecimen life cycle for clinical studies in IO and working with central laboratories
- Knowledge of optimal biospecimen processing and biomarker sampling plans for clinical trials in IO which requires proven ability to manage complex biomarker sampling plans under aggressive, often accelerated timelines
- Sufficient understanding of scientific rationales behind biomarker strategies in IO
- Familiarity with technology and tools used to track chain of custody and manage biospecimens
- Experience with informed consent regulations related to biospecimens
- Prior experience working with, managing and developing relationships with biospecimen management vendors
- Advanced knowledge of GCP/ICH, biospecimen management systems, clinical development processes and R&D/clinical laboratory techniques
- Demonstrated management ability with experience managing on-site and remote teams
- Demonstrated team building and leadership experience including ability to build cross-functional relationships while playing a positive role in building team dynamics
- Ability to work in a multifunctional team environment, interact with a wide variety of internal and external stakeholders and related to individuals at all levels of the organization
- Strong strategic/resource planning/project prioritization capabilities and problem-solving skills
- Prior experience with corporate drug development and submissions, particularly clinical development, and translational medicine
- Detail-oriented and able to successfully multi-task, supporting several projects
- Excellent oral and written communication skills
- Up to ~20% travel to Celgene corporate sites, CROs, investigator meetings/clinical sites, and/or external conferences
#LI-POSTCelgene 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.