Gbs&Im Biospecimen Lead - Hyderabad, India - Bristol Myers Squibb

Description

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: .

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, biological specimens; along with managing biospecimen information-driven by end-to-end visibility and best in class logistics.

Position Summary

No direct reports (this text for hiring requisitions only)

Manager, Biospecimen Planning independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-2a clinical trials and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies initially under the guidance of senior colleagues 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 Early Development assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.

Position Responsibilities

• Oversee and manage the complete lifecycle of biospecimens collected for early phase clinical studies with minimal supervision.
• Core Clinical Team member responsible for providing Shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc.).
• Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed.
• Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking.
• Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or Polaris (if applicable)) with support.
• Able to identify biospecimen related risks with support from risk library. May require support for de novo risks and mitigation strategy proposals. Support Critical to Quality (C2Q) process with guidance, if needed.
• Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. May need assistance to help prioritize BOW activities during critical deadlines.
• Maintain intermediate working knowledge of compound and study related biospecimen requirements.
• Ensure completion of individual Study Transition Forms

Degree Requirements

Scientific degree (Associates, Bachelors, Masters, or higher), Project management or equivalent experience.

Experience Requirements

Minimum of 2 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent.

Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data and risk management.

Experience desired but not limited to: biospecimen life-cycle/operations, compliance, management and vendor management.

Key Competency Requirements

Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent.

Vendor experience preferred (e.g., Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc.).

Ability to develop skills with training for stakeholder management including conflict and change management.

Biospecimen Operations Experience preferred but not mandatory.

Developing knowledge of the drug discovery or developmental process.

Applies Scientific and/or functional knowledge to conduct studies in assigned area.

Ability to effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, with limited supervision.

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.

Demonstrates change Agility through willingness to pivot current ways to working to new model(s)

#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply 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 scienceTM , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply 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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit 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.