At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The division of Global Product Supply at Bristol-Myers Squibb is seeking a highly motivated scientist to join our Sterile Products Development group. The successful applicant will be primarily responsible for the technical advancement of biologic drug candidates in support of formulation and process optimization throughout all stages of clinical and commercial drug product development.  The role will be laboratory-facing and it will provide significant opportunities for working closely with other laboratory-based scientists, learning standard protein analysis and characterization techniques, exploring new techniques, and contributing to team problem solving and scientific investigations.

This individual should have strong fundamental knowledge of protein structure, function, bio-molecular interactions and stability relationships, as well as strong scientific thinking, creativity and problem solving skills. Hands-on experience with analytical and biophysical characterization techniques for monitoring and investigating protein dynamics, stability and higher order structure under physiologically or pharmaceutically relevant conditions is highly desirable. Additional background or knowledge of chemical biology, structural biology or protein engineering concepts, is also highly desirable.

The successful candidate must have a passion for learning and practicing science, along with excellent interpersonal communication skills and enthusiasm for working with multidisciplinary teams.  This requires an excellent sense of time management, organization and multitasking.  High standards of laboratory safety, documentation practices and interpretation and presentation of scientific results are also required.

Qualifications:

The successful candidate must have a degree in chemistry, biochemistry, engineering or related field, with 0-3 years of relevant industrial or academic experience required with a M.S. degree, or a minimum of 5 years of experience with a B.S. degree.

The successful candidate must have demonstrated working knowledge or hands-on experience using protein analysis and characterization methods and a proven track record of productivity, creativity and scientific contributions. Additional practical experience or working knowledge specific to spectroscopic-based methods, separation techniques and coding/scripting for automated data analysis and molecular dynamics simulation is desirable.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary / Objective

Global Submission Management is an organization that delivers compliant Health Authority submissions to support the BMS portfolio and provides submission strategies for drug development, drug approval, and maintenance of market approvals.

Position Responsibilities

• Drives the execution of the Global Submission Plan through collaborating with team members and vendors.
• Tracks the progress of all components for submissions to health authorities.
• Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced.
• Assures regulatory guidelines are followed for electronic format and review both submission ready documents and dossiers for compliance to these guidelines.
• Demonstrates a good working knowledge of global regulatory practices and requirements and supports liaisons, CMC, Safety, and other regulatory functions as appropriate.
• In depth knowledge of dossier production and provides advice, mentoring, and guidance regarding regulatory and submission requirements, submission strategies, dossier content, and format.
• Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections
• Other miscellaneous regulatory operational activities (e.g. US export waivers, translation document management, etc.)
• Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Manager)

Degree/Experience Requirements

• BA/BS degree and 3+ years of relevant regulatory/submissions experience. Publishing/eCTD submission experience highly desired.

Key Competency Requirements

• Working knowledge of global regulatory practices, electronic submission guidelines and requirements.
• Ability to lead multi-functional submission teams and track progress of dossier components to ensure timely execution of submissions.
• Ability to interact and negotiate with outside suppliers on Global Submission Management matters.
• Strong working knowledge of eCTD publishing standards is critical.
• Exhibit strong attention to detail, have good organization, communication, and collaboration skills, and seamless multi-tasking abilities to be able to work simultaneously on multiple projects.
• Needs to be able to effectively adjust plans to deal with change and be flexible. Must be able to think in a clear, decisive manner under submission timeline pressures.
• Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such systems.
• Be flexible in working hours; sometimes including nights, holidays and weekends as needed.
• Travel as needed: 5%

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsible for performing different parenteral manufacturing operations of highly sensitive pharmaceutical/biologics products and equipment. Performs necessary set-ups, and changeovers, equipment cleaning, and line clearance as described in the Standard Operating and Safety Policies and Procedures (SOP’s). This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Major Duties and Responsibilities:

1.  Performs the assigned activities related to the equipment set-ups, changeovers equipment cleaning, and line clearance to achieve an efficient operation of the different processes and products yield maximizing.

• Operates and understands the preparation, formulation and filling equipment functions and basic troubleshooting activities
• Cleans, sanitize, and sterilize manufacturing area rooms and equipments.
• Runs autoclaves to sterilize equipment to be used in the manufacturing process.
• Performs CIP and SIP (Cleaning in Place and Sterilization in Place) of the tanks.
• Performs integrity test of all filters used in the process before and after each use.
• Receives, handle, verifies and weigh excipients and drug substance and or active ingredient to be used in the formulation process.
• Executes the product formulation as per Batch record and Procedure instructions; this includes pH measurements and adjustments, yield calculations, and volume adjustment.
• Performs sampling of bulk solutions as per batch record requirements.
• Interacts with computer controlled equipment and processes.
• Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.
• Verifies calibration status of critical instruments before process operation.
• Operates in an efficient manner of the manufacturing processes to maximize product yield of products.
• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Performs systems integrity test such as isolators, ultra filtration skid, distribution systems, filters and gloves as required. Complete production documentation legible, error free and on time following good documentation practices.

2.   Ensures the completeness and compliance of all required documentation during the manufacturing process.

• Maintains inventory and request all necessary components and operating materials.
• Receives, verifies all production records and transaction documents to be error free and in compliance with established procedures, including computer generated transactions.
• Completes production documentation legible, error free and on time following good documentation practices.
• Audits batch records and documentation, as required.
• Assures that the Compounding equipment is in good working condition, clean, labeled, and calibrated and/or qualified according to applicable SOP’s before performing the formulation process.
• Revises and improves procedures and develops new SOPs based on observations and experiences.

3.   Provides assistance and supports to manufacturing related activities

• Initiates, participates, and assists in resolution of quality investigations.
• Assists in “on the job training” for new employees.
• Participates in special projects and during audits and regulatory inspections as required.
• Participates and assists in area validation and qualification activities.
• Supports Environmental Monitoring Program by assuring samples collection on established timeframe.
• Supports Annual Requalification Program by assuring plan execution on established timeframe.     
• Assists manufacturing activities in other areas within operations as required.
• Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to supervision, as requested by supervisor.

4.   Performs GMP Safety and Environmental regulatory tasks required in the manufacturing area.

• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Handles Hazardous and Non hazardous waste according to EHS procedures.
• Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.

Knowledge/Skill:

• High school diploma with, two (2) years of experience in Parenteral Manufacturing Process  or three (3) years of experience in pharmaceutical manufacturing process.
• Knowledge of preparation, formulation and filling processes.
• Basic writing skills when completing area documentation.
• Basic knowledge on Computerized, PLC control equipment, procedures and new scientific processes.
• Ability to work with minimum supervision.
• Ability to provide job training, theoretical and or On the Job, for new employees following the Parenteral Operations Department Qualification Curriculum.
• Knowledge of all critical process parameters and their impact in product quality.
• Knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization and isolators technology. .
• Understanding of Process Equipment set-up and able to perform it repeatedly and according to SOPs.
• Ability to apply critical thinking to resolve complex issues.
• Excellent leadership characteristics, accountability and commitment.
• Team player and collaborating skills.
• Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
• Skill in performing detailed tasks and documenting information.
• Ability to enter data into a computer and perform complex process transactions.
• Skill in accurate visual inspection (e.g. product and components defects)
• Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
• Skill in basic mathematical applications.
• Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
• Strong organizational skills

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The BMS Manufacturing Science & Technology (MS&T) Process Engineering team is seeking a highly motivated Masters or PhD candidate for a six-month co-op internship starting in January 2021, located at the BMS facility in Devens, MA. The co-op would be working under the supervision of a Senior Engineer and would collaborate with cross-functional groups within the MS&T and Product Development organizations to develop advanced process models using computational fluid dynamics (CFD) and other modeling tools and approaches. 

Key Responsibilities:

Through this role, the candidate would gain knowledge on the application of chemical/biochemical engineering principles to biologics manufacturing and development, experience of building advanced computational models to facilitate scale-ups and technical transfers, and experience working in a diverse cross-functional team.

Qualifications and Experience:  

• Strong foundation in Chemical/Biochemical Engineering principles and their application to generating Computational Fluid Dynamics (CFD) models.
• Familiarity with commonly used Biologics manufacturing equipment such as bioreactors, mixing vessels, chromatography columns, etc.
• Familiarity with protein production and knowledge of GMP is preferred, but is not a pre-requisite.
• Previous Experience using Ansys Fluent software to build CFD models is strongly preferred.
• Strong communication skills: Good technical writing and presentation skills are preferred.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Support Scientific Education, Hematology, Team in reviewing unsolicited grants, preparing RFEs, developing needs assessments and learning objectives aligned with strategy, and other key projects in Scientific Education as assigned.

Key Responsibilities:

•    Reconciliations/Outcomes Assessment: Review received items in database and triage to Grant Managers; make initial assessments daily
•    Overdue Account Monitoring: Review overdue accounts weekly and send to requesting organizations instructions how to fix 
•    Assist in grant review of unsolicited grant requests in hematology
•    Maintain Heme SharePoint organization and inventory
•    General research to support new Ed Obj across Sci Ed to address patient shared decision making, technology as element of patient care, clinical trial understanding/or overall education needs in research/development, gather QI measures or Patient Reported Outcomes measures to include in Ed Obj etc.
•    Disease specific Needs Assessments: Conduct needs assessment/gather data
•    Assist in developing therapeutic area specific requests for education (RFEs) to support Associate Director and Senior Manager.
•    Assist or take on special projects as needed based on bandwidth of the Senior Director, Associate Director and Senior Manager
Qualifications and Experience:

Prefer candidate has some pharmaceutical industry experience, ideally working in IME or similar area; experience in hematology a plus, experience working across a matrixed team. Ideally, a pharmacy student or pharmacist but not required. Positive attitude and eagerness to learn and develop are definitely factors that will be needed. Ability to develop strong relationship across a wide variety of teams.
 

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position: Business Operations Lead for Global Regulatory Strategy & Policy (GRSP)

Direct Manager: Head, Business Operations

Division: Regulatory Affairs

Location: Summit NJ

Grade: D07

Direct Reports: Yes

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Business Operations Lead for Global Regulatory Strategy & Policy (GRSP)

Summary

The Business Operations Lead will be a key member of the Business Operations leadership team for Global Regulatory Strategy & Policy.  This individual will oversee a team of Global Regulatory Managers, with responsibilities that include line management, people development, operational excellence initiatives, and proactive stakeholder management.

• Line Management and Team Member Development:
  • Support the GRM Community of Practice knowledge and sharing learning forums to empower team development and initiatives
  • Continually evaluate GRM core competencies for career growth and development opportunities
  • Foster a culture of continuous regulatory improvement and sustainable high standards of performance through training, coaching and stakeholder engagement
  • Direct training and onboarding of new hires for evaluation of development progression
  • In partnership with Business Operations leadership, strategically plan and implement resourcing solutions based on the business need
  • Manage and support Global Regulatory Managers (GRMs) in the coordination and creation of governance-approved global regulatory plans and transmittal to cross functional SMEs for execution
  • Manage and support regulatory work schedules with for assigned projects using common data points and milestones, annual reports, PMR and PMCs
  • Manage, track, review regulatory deliverables for each therapeutic area to ensure BOW is equitable across team members

• Operational Excellence:
  • Create a bridge for regulatory workflow processes across matrix team model to provide practical solutions to a wide range of challenging technical or operational concerns
  • Drive the development and execution of portfolio reporting and analytics
  • Develop the delivery of end-to-end key regulatory document(s) improvements

• Stakeholder Management:
  • Strategically seeks opportunities to enhance value of internal stakeholder relationships through early operational engagement and ongoing partnership interactions
  • Demonstrates strong communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution
  • Communicates regulatory business operations strategy and decision-making across a matrix team model
  • Demonstrate proactive measures to ensure Business Operations team is engaging in valuable regulatory team interactions to coordinate and support GRSP HA activities lead by regional / local liaisons
  • Actively engage with leadership cross functional team members and escalate issues proactively

Qualifications/Requirements

• Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary)
• Solid working knowledge and experience (at least 5 years) with regulatory procedures and submissions (US, EU, or other)
• Comprehensive understanding of the pharmaceutical industry
• Demonstrates a high-level of self-motivation and professional commitment. Indirect management experience of people or major projects
• Ability to manage people effectively 
• Ability to rapidly adapt to different issues and projects at one time
• Excellent communication and interpersonal skills
• Comfortable working in a fast-paced environment where speed is paramount
• Willing to work as a subject matter expert in a matrix team unified around serving the assets
• Ability to recognize, articulate, and accept calculated risks to make informed decisions for the benefit of meeting deliverable timelines
• Willingness and ability to effectively cooperate and partner with internal and external stakeholders
• Understanding of multiple therapeutic areas to effectively manage direct report BOW/projects
• Increased exposure to global and multifunctional teams

Other Qualifications:

• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals
• Communicates opinions, facts and thoughts with clarity, transparency and honesty
• Seeks multiple perspectives and listens openly to others’ points of views
• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
• Demonstrates ownership of results within (and beyond) area of responsibility
• Sets clear and high expectations and holds self and others accountable for decisions and results achieved
• Looks for opportunities for continuous improvement

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

As the Growth & Development Assistant you will be involved in various aspects of the team’s work, including providing support for recurring development programs (communications, curation of follow up resources, and roster management).

Key Responsibilities
•    Under guidance of Director, Manager Development, support the design, management and execution of monthly Global Manager Forums that build capability for the population of 7000+ people leaders.
•    Assist the onboarding of new learning & development providers.
•    Align the learner experience across all the external partners in the manager development space.
•    Update online documentation, quick reference, job aids, etc. related to the manager learning journeys.
•    Gather data for learning & development dashboards on enrollment, learner satisfaction and other relevant metrics.
•    Develop communications to promote new development offerings and resources.
•    Liaise with global learning & development points of contact and domestic HR partners to support the diagnoses of L&D needs and plan the learning schedule to respond to these.
•    Assisting with development of power point presentations and other documents.

Qualifications & Experience
•    Bachelor’s degree or equivalent experience required 
•    Interest in the field of Learning & Development and a strong personal learner
•    Strong interpersonal skills, excellent organizational abilities, and the strong ability to multi-task
•    Excellent communication skills both written and verbal are required
•    Good working knowledge of Excel, Word, Outlook, and PowerPoint. Knowledge of SharePoint is desirable
 

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Co-op will perform studies and experiments that will provide additional characterization of analytical assays to provide enhanced capabilities to evaluate the belatacept manufacturing process.  Aid in the experimental design, data evaluation, data verification, performance of the methods, and present data.  

Key Responsibilities
•    Value added experimental design
•    Troubleshooting of instrumentation
•    Run analytical method
•    Data Evaluation
•    Develop general biologics process knowledge and an appreciation of the importance of analytical quality attributes and how they drive process decision. 

Qualifications & Experience
•    Individual should have practical lab experience, including pipetting, preparing serial dilutions, handling possible hazardous chemicals, and reagents with a critical focus on safety.  
•    Desired instrumentation experience includes: balance, pH meter, HPLC, and spectrophotometry.  
•    Excellent communication, technical writing, collaboration, and data management skills are required.
•    Technical writing ability required, as well as expertise in Microsoft Word, Excel and PowerPoint and the ability to perform statistical data analysis.  
•    Demonstrated problem solving ability, interpersonal skills, and oral and written communication skills.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

In this role, the selected candidate will use cheminformatics methods, scalable cloud high performance computing resources and an open source machine learning platform to build and refine a predictive model relevant to drug discovery.  The candidate will leverage publicly available data to train an initial version of the model and generate statistics on its performance.  The candidate will then add proprietary in-house data to augment the publicly available data and compare the model with and without the additional data.  The position will provide the successful candidate with an introduction to representing small molecules in a computer, understanding machine learning platforms and techniques as well as introducing scalable cloud computing. 

Key Responsibilities:

• Gather and clean data to prepare input datasets for machine learning. 
• Collaborate with the computational chemistry and cheminformatics teams to understand the value and purpose of predictive models in drug discovery.
• Build, tune and test machine learning models. 
• Document and deploy models to the scientific community at BMS. 

Qualifications and Experience:
• Elementary python programming/scripting skills. 
• Familiarity with linux is a plus. 
• Strong communication skills and a highly motivated scientist interested in chemistry and/or computer science. 

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Functional Area Description

• Serves as a primary source of medical accountability and oversight for clinical trials
• Matrix management responsibilities across the internal and external networkManages Phase 1 – Phase 3 studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional BMS colleagues

Position Responsibilities

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)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training

Clinical Development Expertise & Strategy

• 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 Clinical Scientists
• 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. Keeps up-to-date 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 CS to allow for protocol-specific training, supporting the study team, investigators, and others

Health Authority Interactions & Publications

• Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial 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 Clinical Scientists

Degree Requirements

• MD required (or x-US equivalent)

Experience Requirements

• 3 or more years of Industry experience and/or clinical trials experience is required

Key Competency Requirements

• Ability to communicate and present information clearly in scientific and clinical settings
• Subspecialty training in applicable therapeutic area desired
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Knowledge of drug development process
• Knowledge of the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment

​

Travel Required

• Domestic and International travel may be required.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.