Posted:
9/20/2024, 12:46:52 AM
Location(s):
New Jersey, United States ⋅ Princeton, New Jersey, United States
Experience Level(s):
Mid Level ⋅ Senior
Field(s):
Medical, Clinical & Veterinary
Workplace Type:
Hybrid
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.
Position Summary
The Clinical Trial Physician (CTP) in the Worldwide Medical Evidence Generation (MEG) group will serve as the primary source of medical/clinical accountability and day-to-day oversight and conduction of the Evidence Generation Book of Work (BoW), including medical affairs-led sponsored studies (interventional and non-interventional), Investigators Sponsored Studies (ISRs) and Clinical Research Collaborations (CRCs), in alignment with the Integrated Evidence Plans for the assets in the company's portfolio. He/she will lead and participate in cross-functional matrix leadership teams (including external vendors/CROs) focused on building these relationships and actively sourcing research concepts that address evidence gaps for prioritized early and late assets. The CTP is also responsible to co-lead the Evidence Generation Plan.
Key Responsibilities
Drive the cardiovascular MEG Book of Work ensuring they are on strategy and executed with rigor and on time and in close collaboration with Global Development Operations (GDO), Worldwide Medical (WWM), Health Economics Outcomes Research (HEOR), among other stakeholders.
Partner with the WWM-CV organization to co-develop the Integrated Evidence Generation Plan and lead the Evidence Generation Working Group (EGWG).
Collaborates with the TA Medical Lead, CTL, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the study concept, study protocol and ICF, authoring and providing medical input during protocol development. Ensure the quality and accuracy of study-related documents are submitted to relevant internal review committees (including Protocol Review Committee/PRC and other relevant governance groups).
Contributes to and is a key member of a Clinical Trial Team (CTT) associated with specific studies.
Accountable for medical data review of trial data, including eligibility assessment and interpretation of trial data results.
Holds responsibility for site interactions in partnership with the Clinical Trial Leads (CTLs) for study-related medical questions and education (including safety management guidelines). Provides medical input into IRB and/or health authority protocol-specific queries.
Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives (if applicable).
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training.
Provide medical oversight and accountability for the study-related work conducted by external partners (CROs), particularly related to medical monitoring-related activities.
Partners with the Clinical Trial Lead (CTL) and Global Trial Manager (GTM) to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.).
Provides continuous medical education in partnership with CTLs and Therapeutic Area Medical Leads related to protocol-specific training (supporting the study team, investigators, CROs, and others).
Provides medical expertise during Study Steering Committees, Investigators' Meetings, and other study-related meetings with external audiences.
Helps to identify and build relationships with principal investigators and other relevant external stakeholders.
Maintains a strong medical/scientific reputation within specific disease area(s).
Authors/drafts clinical content for CSRs, regulatory documents, and submissions (if applicable) to support closure, clinical narratives, reporting and filling of the study in partnership with CTLs.
Employ strong business acumen and fiscal stewardship focused on driving reciprocal scientific value creation and allocate resources consistent with company priorities.
Qualifications & Experience
MD required (or x-US equivalent).
2-3 years of clinical trial experience, either in industry or an academic setting; expertise in the drug development process and clinical research. Experience with implementation and conduction of medical affairs-led studies desirable.
Demonstrated track record of leadership in a complex, matrix environment.
Experience delivering successful results in a variety of business situations.
Ability to communicate information clearly and lead presentations in scientific and clinical settings.
Successful track record of leading through influence and working across complex, global organizational matrices.
Domestic and International travel is required.
Key Competency Requirements
Demonstrated ability to strategically analyze data generation opportunities with minimal supervision.
Demonstrated ability to develop and sustain high-performing relationships with external thought leaders and internal matrix stakeholders.
Adeptness at building credibility with external investigators and collaborative partners competently balancing business and scientific acumen complemented by strong leadership behaviors, authenticity, agility, and an enterprise mindset.
Understanding of global healthcare systems and academic settings with a demonstrated ability to lead in an ambiguous and changing healthcare/business environments.
Exceptional communication and interpersonal skills to influence decision-making at all levels of the organization.
In depth knowledge of overall project planning and project management of clinical trials.
Proven ability to partner effectively with colleagues across multiple functions and at all levels of the enterprise.
Exceptional interpersonal and communication skills appropriately flexing based on audience; expertly leverages effective communication and negotiation skills to influence decisions.
30% expected travel globally.
#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 science™ ”, 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 [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.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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Website: https://bms.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1887
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine