Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.
Functional Area Description
Support the strategic and tactical planning as well as operational management of biospecimens, which contribute to asset development. Our functional teams ensure timely availability of high quality, accurate, and annotated digital and biological specimens; along with managing biospecimen information, driven by end-to-end visibility and best in class logistics.
Position Summary
Associate Director, Biospecimen Operations will work closely with our Biospecimen Planning Lead and Clinical Teams, to develop and implement biospecimen management plans for BMS-sponsored Full and Late phase clinical trials, and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies, and work across the organization and with BMS’s partners to implement and project manage efforts to execute these strategies. Critical to this role is the ability to provide innovative solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS’s continuous competitive advantage. The individual will be responsible for supporting biospecimen management for the Full and Late Development assets, with opportunities to contribute toward optimizing work streams cross functionally, throughout the organization as it relates to biospecimens. The individual will be responsible for supporting biospecimen management for the Late and Full Development assets, with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.
Position Responsibilities
Conducts tasks in support of Operations-based scope, for highly complex studies, expertly with no supervision.
Ability to support and think at program level, for Strategic Specimen Planning and Development (SSPED) and biological Specimen Management Plan (SpMP) processes, expertly for highly complex assets, with no supervision. Drive and complete operational tasks dependent on these processes.
Shipping/sample movement mgmt. including requests, query and inventory reports, follow up active issues with vendors, complete sample mgmt. related reports in support of BSOL team, review/prep tracking activities (like vendor manifests/inventories, tissue/blood match pairing, deleted/non-viable samples, loading documents to Shared Drive folders, etc.).
Expertly reviews all biospecimen related sections of the clinical study protocol, providing comparison of vendor statement of work and biospecimen relevant sections and feedback.
Can identify and resolve vendor related issues, in addition to vendor management responsibilities.
Able to request and/or access necessary vendor/system inventory files to perform specimen tracking and Complex Data Integration with enrollment and vendor specimen inventory.
Able to expertly track biospecimens, and teach others using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)).
Able to expertly identify biospecimen related risks, with support from risk library as well as de novo. Able to provide mitigation proposals to stakeholders. Maintain risk library with up to date biospecimen related items. Expertly supports Critical to Quality (C2Q) process.
Maintain expert working knowledge of asset and study related biospecimen requirements. Has thorough knowledge of principles and concepts in other disciplines or areas of specialization. Demonstrates knowledge beyond own area of specialty. Makes decisions that require choosing between multiple options to resolve complex problems/issues.
Ensure completion of individual Study Transition Forms.
Might offer opportunity to manage direct/dotted-line reports
Degree Requirements
Scientific degree (AB/AS, BS, MS or higher), Project Management or equivalent experience.
Experience Requirements
Minimum of 5 years academic, biotech, healthcare, or pharmaceutical industry experience.
Expert understanding of clinical research including aspects such as: GCP, GLP, CLIA, data management, risk management, and regulatory issues.
Prior experience in biospecimen life cycle/operations, biospecimen result and data flows, compliance and management, vendor management.
MS Excel Intermediate/Expert
Key Competency Requirements
Demonstrated Clinical Trial Experience (Late/Full Development Preferred), healthcare/medical/laboratory or equivalent.
Vendor experience (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.). Identifies and resolves cross functional vendor related issues, in addition to vendor management responsibilities. Services as an SME for vendor management.
Possesses skills to successfully manage direct reports and develop people. Develops and mentor junior staff to autonomously support trials.
Independently identify enterprise-wide issues and oversees initiatives for solutions. Makes decisions that may require developing new options to solve complex problems/issues.
Regularly adapts standard methods and processes, by ing breadth of knowledge and prior work experience. Well-versed in the drug discovery and development process. Demonstrates expert ability, imparts knowledge to others.
Ability to display skills for stakeholder management, including conflict and change management. Develops and maintains strong working relationships with colleagues and external stakeholders.
May represent the organization as prime contact on projects requiring cross-functional coordination inside and outside the company. Projects may be self-initiated.
Key representative on core team during inspections.
Incorporates and develops state-of-the art techniques to enhance productivity.
Superior time/organizational, critical thinking and analytical skills. Manages and/or Leads Independent enterprise-minded projects and initiatives in addition to assigned BOW. Consistently exhibits the ability to prioritize BOW activities in a timely fashion during critical deadlines, with no supervision.
Often acts independently to achieve predetermined goals and objectives.
Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability, and integrity, and to have fun along the way.
#HYDDD
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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