Bristol Myers Squibb

Clinical Operations

• Lead the planning, execution, and closeout of clinical trials from Phase I–III
• Oversees and manages CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines
• Leads the cross-functional study execution team in achieving the study goals and deliverables
• Plan and execute study timelines
• Monitor study progress, including enrollment, site performance, data quality, and key risk indicators and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
• Identify, assess, and mitigate operational risks; escalate issues as needed
• Manage study CRO and vendor budgets and invoicing procedures according to study contract
• Lead/support country and site feasibility, selection, and activation strategies
• Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provides input to operational strategy, including country and site feasibility and start-up
• Summarizes CRO, vendor and site performance data and escalates study risks to the Clinical Operations Program Lead / Head of Clinical Operations
• Performs other related duties as assigned

Clinical Trial Manager, Clinical Operations

Community Manager

• Promotes approved indications of BMS products within a defined territory or region to meet or exceed assigned sales targets in a compliant manner.
• Creates demand for BMS medicines by articulating in a balanced manner the clinical and scientific rationale for use of products in appropriate patients.
• Engages with and continuously maintains/grows a high level of scientific expertise in all assigned products and therapeutic areas.
• Prepares and successfully implements comprehensive territory and account plans.
• Proactively uses available tools such as SOPHIA to derive insights and to dynamically inform call plans.
• Provides feedback on experience using these tools to leadership to enable continuous improvement.
• Demonstrates scientific expertise and passion in using approved scientific resources and publications to present information to HCPs and ensures medical accuracy.
• Conducts in-office presentations (e.g., lunch and learns) and discusses product-related scientific information with HCPs that is consistent with label.
• Organizes external speaker programs, selecting speakers from list approved by Speakers Bureau and facilitating scheduling and logistics.
• Maintains a high level of working expertise on emerging data for approved indications.
• Engages real-time medical support through Medical on Call to reactively answer unsolicited questions and complex technical inquiries.
• Proactively collaborates with other field teams to ensure the best Customer Experience (Cx) for HCPs.
• Gathers and shares relevant insights and information internally with the appropriate stakeholders to enable BMS to better serve its customers.
• Complies with all laws, regulations, and policies that govern the conduct of BMS.

Senior Therapeutic Area Specialist, Cardiovascular

Director

• Serves as a primary source of medical accountability and oversight for clinical trials.
• Matrix management responsibilities across the internal and external network.
• Manages Phase 1 – Phase 3 studies, with demonstrated decision making capabilities.
• Provides medical and scientific expertise to cross-functional BMS colleagues.
• Medical Monitoring: Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT).
• Conducts medical data review of trial data, including eligibility review.
• Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines).
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives.
• Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations).

Associate Director, Global Clinical Physician, Neuroscience

Manager

• Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct.
• May serve as Clinical Trial Lead for one or more trials.
• May lead or support trial level activities for one or more trials with the necessary supervision.
• May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members.
• Collaborate and liaise with external partners (e.g., KOLs).
• Seek out and enact best practices with instruction.
• Provide regular and timely updates to manager/management as requested.
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
• Conduct literature review.
• Submit clinical documents to TMF.
• Develop site and CRA training materials and present these at SIVs and Investigator meetings.
• Review clinical narratives.
• Monitor clinical data for specific trends.
• Develop Data Review Plan in collaboration with Data Management.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

Senior Manager, Global Clinical Science, Neuroscience

• Responsible for implementation, planning, and execution of assigned clinical trial activities.
• Serves as Clinical Trial Lead for one or more trials.
• Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
• Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership).
• Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team members.
• May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning).

Associate Director, Global Clinical Science – Neuroscience

Consultant

• Drive peer to peer interactions with customers that optimize patient outcomes by delivering end-to-end clinical exchanges that clarify the complexities of patient identification and management.
• Develop and maintain relationships with academic and community HCPs within assigned geography to provide clinical and product education for BMS hematology and oncology products.
• Actively assess the treatment and patient management landscape by meeting with HCPs to understand their needs and current patient management processes/protocols.
• Deliver educational speaker programs to HCP customers in approved out of office settings.
• Provide product demonstrations and infusion support for CAR T sites starting new patients.

Clinical Nurse Consultant

• Define and drive the integrated evidence generation strategy (IEP) aligned with Medical Affairs and overall product strategy.
• Provide leadership in Request for Proposal (RFP) process working with cross-functional team.
• Provide hands-on scientific leadership in the design of clinical studies (CRC and MAST) including Phase II/IV trials, post-marketing commitment studies as applicable.
• Significantly contribute to protocol development as applicable, including Study design, Study objectives and endpoints, Eligibility criteria, Statistical considerations (in collaboration with Biostatistics), Operational feasibility.
• Be accountable for delivering CRCs, ISRs, and MASTs from concept ideation to governance approval and throughout the study lifecycle.
• Serve as a thought leader on evidence generation methodologies to ensure evidence plans are fit-for-purpose and impactful.
• Lead preparation and delivery of evidence generation proposals and updates including results to internal governance bodies and cross-functional stakeholders.
• Apply strong understanding of GCP, ICH guidelines, and clinical trial governance to ensure compliant and high-quality study execution.
• Partner with Clinical Operations and CROs to ensure studies are delivered on time, on budget, and with high data quality.
• Review and interpret clinical and real-world data to ensure medical relevance and scientific integrity.
• Engage with key opinion leaders (KOLs), academic investigators, and external research partners to co-develop high-impact evidence.
• Participate in advisory boards, steering committees, and scientific forums as necessary.
• Collaborate with cross-functional partners to ensure cohesive planning and execution of evidence generation activities across geographies and therapeutic areas.
• Oversee operational delivery of studies, ensuring scientific rigor, quality, compliance (GCP/SOP), timelines, and budgets.
• Act as a trusted internal advisor to global and regional Medical Affairs, Clinical Development, Access & Value, Regulatory, and Commercial teams on evidence gaps, opportunities, and study strategy.
• Contribute to scientific dissemination through publications, abstracts, congress presentations, and advisory boards.
• Contribute to the evolution of MEG therapeutic area strategy and value proposition.

Director, MEG Lead – Neuroscience, Medical Evidence Generation

• Builds and maintains professional contacts with office staff in private practice, medical group practices and/or hospitals, and others in the patient care continuum.
• Develops deep market access expertise in the assigned geography and anticipates implications for BMS brands (and their key competitors) in areas of enterprise focus and patient support priorities.
• Maintains expertise in changing healthcare landscape, including market trends and payer dynamics.
• Proactively shares reimbursement related education to offices as appropriate, educating staff on enrolling appropriate patients into BMS patient support programs.
• Reactively manages patient cases enrolled into BMS Hubs, working with office staff to facilitate continuity of care, post the clinical decision.
• Compliantly shares account knowledge and insights to enhance ONE BMS matrix team approach.
• Provides Home Office approved reimbursement related updates to District Manager and sales representatives within own geography as appropriate.
• Complies with all laws, regulations and policies that govern the conduct of BMS.
• Estimated 20%-30% of overnight travel required, based on where the candidate resides in the territory.
• This role reports to the Region Director of the Northeast Region. Prefer candidate to live in within territory geography boundary. Relocation is not available.

Patient Access & Reimbursement Manager

• Supervise and/or mentor other CP&P leads as appropriate.
• Independently contribute to compound development across various development phases.
• Represent Clinical Pharmacology at asset teams at governance based on proficiency.
• Provide input to Phase 2/3 clinical study design and registrational strategy.
• Accountable for Clinical Pharmacology and Pharmacometrics Plan.
• Lead design of Clinical Pharmacology studies and manages data analysis, interpretation, and reporting.
• High proficiency in PK, PK/PD, and model informed drug development (MIDD) principles and analyses.
• Collaborate on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology subject matter expert.
• Participate in interactions with health authorities; serve as Clinical Pharmacology subject matter expert.
• Lead and participate in departmental initiatives and represent CP&P on cross-functional initiatives / workstreams / taskforces.
• Work with Business Development teams and provide critical expertise to assess external acquisitions.

Director, Clinical Pharmacology

• Serve as the commercial point on the submission, GPS and extended Global Product Team, providing critical commercial insights, input and shaping the product strategy, and label optimization
• Identify and analyze market trends. Apply deep market and competitive insights to define growth opportunities and ensure competitive readiness and differentiating strategies
• Drive Global Launch Readiness efforts to ensure successful preparation of essential disease state and promotional global deliverables within G2L framework
• Lead Global Launch Forums: Global Launch Readiness Team/LRT with global cross-functional partners and Commercialization Launch Exchange with early launch and PoC markets. Champion utilization of global SmartLaunch Online Playbook.
• Collaborate with core markets to ensure optimal opportunity assessments and resource allocation requests as part of CSRE and G2L framework, to support successful launch readiness and commercialization / go-to-market strategies for core and POC markets
• Lead foundational strategic brand deliverables, including Unified Brand Plan (UBP), Unified Strategic Plan (USP), and Brand Book / Brand Guidelines
• Ensure strong collaboration and alignment of overall strategy with cross-functional partners, Disease Area Strategy (DAS) and Cell Therapy teams
• Engage with key opinion leaders, establish strong partnerships, and ensure pull-through of appropriate customer feedback and customer-centric thinking in strategic plans
• Manage agency/vendor partnerships
• Oversee budget for marketing and extended commercial team functions

Director, Global Commercial Strategy, MM, CELMoDs

Compliance

• Will be a key member of the GRSP Extended Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area.
• Acts as regulatory representative on various company-wide projects and initiatives.
• Support due diligence and business development assessments.
• Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products: Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products.
• Review/provide counsel on product development plans.
• Assemble the global regulatory plans for identified projects/products.
• Influences and imparts broad expertise regarding US and international regulatory environment.
• Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.
• Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects.
• Serve as the primary interface with health authorities on assigned projects.
• Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them.
• Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources.
• Works with regional international staff for diverse health authority submissions.

Senior Director, Global Regulatory Lead, Neuroscience

People Operations

• Serve as a trusted advisor to managers, providing guidance and support on complex workforce matters and HR policy.
• Proactively develop and implement strategies to upskill new People Managers and provide support and counsel to experienced People Managers navigating HR processes and issues.
• Exercise discretion, sound judgment, and appropriate decision-making to determine the most effective path to resolution.
• In partnership with HRBPs, use diagnostics, data, and business insight to identify proactive HR interventions and people practices that support local business objectives.
• Ensure that the workforce and leaders understand People processes.
• Coordinate and enable seamless end-to-end delivery of global priorities and lifecycle processes in partnership with People Services teams, while advocating for improvements that enhance the employee experience.
• As required, partner with global Centres of Excellence (COEs) and Process Designers to roll out global programmes and processes effectively and ensure smooth implementation.
• Develop and maintain a strong understanding of employment legislation and market practices across the Americas Region, including the US, Latin America, Canada, and Brazil, to help ensure that processes and policies remain compliant with local requirements and to partner with COE and People Services colleagues on required updates.
• Research, resolve, and respond to issues requiring an HR perspective, working closely with People Services colleagues, HRBPs, and COEs.
• Work collaboratively with peers and matrix colleagues to share ideas for driving improvements and consistency of execution for key HR processes, across the Americas Region.
• May also lead or contribute to country-specific, regional, or global People-related projects across the Americas Region, as required.

HR Generalist – People Consultant

Clinical Research

• Collaborate and liaise with external partners (e.g., KOLs).
• Seek out and enact best practices with instruction.
• Provide regular and timely updates to manager/management as requested.
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
• Conduct literature review.
• Submit clinical documents to TMF.
• Develop site and CRA training materials and present these at SIVs and Investigator meetings.
• Review clinical narratives.
• Monitor clinical data for specific trends.
• Develop Data Review Plan in collaboration with Data Management.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

Senior Manager, Global Clinical Scientist – Psychiatry

• Collaborates in design of clinical study including methodology, data analysis & interpretation, and reporting of study results.
• Authors and/or reviews protocol synopsis, protocol, statistical analysis plans, case-report forms, clinical study reports, associated publications, and other study level specification documents with minimum supervision.
• Performs and/or validates statistical analyses, advise ways to maximize clarity of data display.
• Communicates results to cross-functional teams, provides data interpretation in study documents such as clinical study reports, and publications.
• Translates scientific questions into statistical terms and statistical concepts into layman terms.
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable.
• Continually develops technical knowledge of statistical methodology and how it is appropriately applied in trial design and data analysis for clear, concise, high-quality results.
• Continually enhances knowledge of drug development process, regulatory and commercial requirement.
• Develops & advises team members.
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.

Senior Manager

• Serves as a primary source of medical accountability and oversight for multiple clinical trials
• Matrix management responsibilities across the internal and external network
• Manages Phase 1 – Phase 3 studies, with demonstrated decision-making capabilities
• Provides medical and scientific expertise to cross-functional BMS colleagues
• Leads medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• In collaboration with the Clinical Development Lead, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
• Provides oversight and medical accountability for a group of studies
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Global Clinical Scientists (CS)
• Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
• Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder.
• Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
• Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Director, Global Clinical Physician
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CSs