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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.

1.Competences

In this position the OSD manufacturing Master Data - Associate Specialist will execute tasks related to Manufacturing and Quality Control master data in the Manufacturing ERP System. This includes and is not limited to: data entry, data analysis, workflow follow-up, functional testing of ERP system, master data technical development, master data SME.

This position will work in close collaboration with the other Boudry/Couvet Manufacturing departments, Global Master Data, Quality Assurance and other internal stakeholders.

2.Skills/Knowledge Required

·      + 1 year experience in data entry

• A first experience with manufacturing ERP
• Concentrated conscious, aiming for “right first time”
• Good insight in processes and dependencies
• Strictly follow established processes but also be able to actively contribute in defining new processes
• Strong team-player
• Conscientious, reliable in action follow-up and priority management
• Excellent IT proficiency: MS Office, Excel, ERP
• Fluency both in French and English is required
• Interested and motivated to expand ERP technical skills
• Knowledge of the GXP environment

3.Duties and Responsibilities

The OSD manufacturing Master Data - Associate Specialist will be required to timely execute the tasks assigned to her/ him regarding standard process and is accountable to ensure compliance with GxP processes in the execution of activities.

She/He will prepare the template files and the relevant workflows of data check within the relevant system. She/He will follow up with the SMEs in regards of timing and questions. She/He will act as a SME in master data workflows. This position is providing support to business and IT users in master data related topics.

The manufacturing ERP data Clerk is considered as knowledgeable of the Manufacturing ERP data and system. She/He will make data entry, data modification and data collection and contact the right SME. She/He will be able to synthesize and analyse the requirement, upon specific request develop, test and implement changes always in compliance with GxP.

This position will participate in team and manufacturing meetings and will be involved in continuous improvement process.

4.EHS

• Promote safe practices and behaviors, follow and respect EHS rules
• Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to prevent similar accidents in the future

5.Function Name for Document Approval

OSD manufacturing Master Data - Associate Specialist

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.

Celgene, a wholly owned subsidiary of Bristol Myers Squibb is looking for a HEOR Manager or Senior Manager to join the team.

As a HEOR Manager / Senior Manager you will:

• Demonstrate the value of Celgene products from an economic perspective and present this evidence with clinical arguments to UK Health Technology Appraisal bodies: NICE, SMC, AWMSG and NCPE.
• Manage the full cross functional process of UK and Ireland HTA submissions from feasibility analysis through to dealing with outcomes post submission.
• Manage business relationships with all relevant customers with regards to HTAs, including physicians, patient groups, academics, economists, HTA bodies.
• Liaise with other members of the Celgene and BMS cross-functional teams on health economic activity e.g. developing RWD to support value story, supporting the BMS UK field access teams with tools such as budget impact models.
• Build strong relationships with medical and economic key opinion leaders, organisations and industry peers to strengthen Celgene and BMS's image, competitive position and performance.

Key requirements:
• Postgraduate qualification in Health Economics or related discipline  

• Working knowledge of HTA decision making processes
• Experience of working in a Pharmaceutical company as a Health Economist/HEOR consultancy

• Experience of working on a UK HTA submissions is highly desired but not mandatory.
• Oncology Therapy Area knowledge desirable
• Life Sciences Degree / Health Economics Degree

Other requirements:
• Demonstrable strong project management experience

• Excellent communication skills with ability to lead cross functional team in an inclusive manner whilst delivering successful HTA dossiers on time
• Experience of working within a matrix environment
• Be solutions orientated with a demonstrable how can we attitude

• Established network of HTA and academic thought leaders

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.

Key Responsibilities and Major Duties

As Country Lead

• Leads by example through championing the notion of independence, objectivity and integrity when delivering insights and analytics to stakeholders
• Represents market BI&A team as a single point at GM’s LT level when required, including budgets, business reviews, refreshes and projections for the BMS Portfolio
• Support the China Operating Committee to develop launch forecast assumptions and scenarios for IO and other BMS franchises
• Create a transparent fact based approach to developing forecast assumptions for all tumor types/assets, and clearly document and communicate supporting data/facts/rationales
• Builds relationships and effectively influences all senior management market stakeholders (GM, BUDs, and appropriate Leads for Marketing & Sales, Finance, Medical, Strategy & Operations) to advance the culture of data-enabled decision making
• Has a strong ability to explain complex dynamics using a simplified synthesis of multiple data sources
• Supports forecasting enablement consistent with the financial planning calendar and ad-hoc business need
• Coordinate scenario communications with GPS, WW Brand Team, WW Pricing & Access, Demand Planning & central BI&A teams
• Review all data sources including internal (e.g. SFE) and external secondary data; and make recommendations to enhance or utilize more effectively
• Oversee all analytics operations to correct discrepancies and ensure quality; manage, direct, and mentor junior team members

As Team Leader

• Drives full, seamless integration of teams to create consistency in quality of deliverables across all functions
• Leverages the onshore/offshore consultant and HQ capability teams to successfully achieve business objectives
• Has strong experience developing and coaching internal talent as well as pipelining external talent to sustain a high caliber team  
• Embeds a OneTeam culture rooted in BMS values: inclusion, integrity, passion, accountability, urgency, and innovation

ESA & CP Capabilities

• Provides IO Portfolio leadership and oversight for the evaluation, improvement, and enhancement of in-market functional capabilities related to forecasting, sales/marketing analytics and market research, including support of data strategy and procurement of innovative data sources
• Applies global standards, models, and templates to drive high quality deliverables
• Proactively looks for opportunities to integrate data from multiple sources to develop richer, insightful and actionable recommendations
• Leads the development and deployment of innovative BI&A approaches, custom analytics, therapeutic area learnings and forecasting best practices
• Shares best practices with and learns from other markets for efficient adoption of learnings and capabilities

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

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.

• Act as a champion for the medical knowledge of a product or products
• Continuously update knowledge of products, patient treatment trends and scientific activities within the Disease Area

Provide timely and informative responses, which accurately reflect scientific data, to scientific queries from external customers and internal partners or liaise appropriately with Medical Information & MSM functions to provide

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.

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.

Functional Area Description

Medical Affairs (MA) serves as disease expert (in this case Inflammatory Bowel Diseases), activities range from educating department members, seeing that health care providers (HCPs) questions are addressed, and providing HCPs informational services in the community. MA also develops publication plans and reports of key trial results at scientific meetings and through journal articles. Key responsibilities include: developing of publication plans, regulatory and safety drug review, acts as liaison to HCPs, professional organizations and disease state advocacy groups, actively participate in thought leader development, support educational meetings, provides the scientific input and expertise in the design and construction of all promotional materials and events and in partnership with R&D oversees the strategy and execution of non-registration data generation, including investigator sponsored trials

Position Summary / Objective

MSMs embody our medical mission in becoming a trusted, agile partner who engages in relevant dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, optimise medical practice and drive appropriate adoption of BMS medicines. The MSM role is a field-based role. It is anticipated that a MSM will spend a minimum of 60-70% of their time in the field with external customers

Position Responsibilities

1. External Environment and Customer Focus

• Develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions. MSM/Ls will use various channels for interactions (1:1, group presentation; remote, etc).
• Effectively present information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives.
• Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise.  Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers.
• Collect and provide meaningful medical insights back to the medical and commercial organisations to be actioned in support of the strategy development.

2. Contribute to the Medical Plan

• Develop territory Field Medical plan and TL Interaction plans based on therapeutic area objectives and TLs needs.
• Adopt institution/account planning approach and contribute to cross-functional institution/account plans.
• Contribute to development and delivery of scientifically meaningful medical programs/projects in line with the local Medical and Field Medical plan.

3. Provide Medical Support

• As necessary and appropriate, support the initial and ongoing medical/scientific area and product specific training and provide key scientific updates to internal stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal, HEOR, Market Access).
• Provide scientific support at promotional meetings by presenting unbiased scientific and clinical data, by evaluating speakers and by giving support to BMS-contracted speakers.

4. Support Clinical Trial Activities

• Support Interventional and Non Interventional Research (NIR) studies (e.g. identification and assessment of potential study sites) to support patient recruitment and/or discussions around the safe and effective use of BMS investigational products, as agreed with local medical management and as defined by the study scope document.
• Provide recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management.
• Actively support CRO sponsored studies as agreed with local medical management and as defined by the study scope document.
• Support HCPs in the ISR submission process as agreed with local medical management.

• Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events.

• Degree Requirements

• MD, PharmD or PhD, with experience in a specific Disease Area or with a broad medical background (preferred) OR Science Graduate with relevant pharmaceutical experience
• At least 1 year of experience in a multinational organization

  Experience Requirements

  Experience Desired

• Working in a scientific and/or clinical research environment
• Ability to work independently and act as a team player
• Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients
• Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals
• Developing peer-to-peer relationships with TLs, scientists and  other healthcare professionals
• Ability to quickly and comprehensively learn about new subject areas and environments

  Key Competency Requirements

• Disease area knowledge and an understanding of scientific publications
• Knowledge of a scientific or clinical area
• Knowledge of clinical trial design and process
• Knowledge of the national healthcare and access environment
• Knowledge of HEOR core concepts
• Excellent English language skills, spoken and written

  Travel Required

  10%

  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 the resources to pursue their goals, both at work and in their personal lives.

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.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb has expanded the large-scale biologics manufacturing facility in Devens, Massachusetts. The expansion included biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing. 

The Assistant Scientist/Engineer will be a part of the Process Development Downstream team in Devens, MA that is responsible for late-stage process development of BMS’s growing biologics pipeline.  This role is within the Biologics Development organization at Devens, MA.  Specifically, this person will be on a team to develop downstream processes, with some focus on (but not limited to) membrane-based unit operations (depth filtration, viral filtration, ultrafiltration/diafiltration).  The candidate will work closely with the overall downstream team, manufacturing, MS&T, analytics, and R&D groups in a matrix, team organization.

Key responsibilities:

• Hands-on operation of equipment needed for downstream process development.

• Design, execution, and analysis of laboratory experiments.

• Support process development and scale-up activities.

• Prepare/review technical documents including development and tech transfer reports.

• Evaluate new technologies and perform the necessary experiments to draw conclusions and make recommendations.

• Support lab initiatives for increased efficiency, organization, continuous improvement.

Qualifications:

• B.S. in Chemical/Biochemical Engineering, Biochemistry, Biophysics or equivalent.

• Prior knowledge/experience in downstream process development and unit operations preferred, including harvest, preparative chromatography, ultrafiltration/diafiltration, viral inactivation and viral filtration.

• Prior knowledge/experience with analytical techniques is preferred, including HPLC, spectrophotometry, electrophoresis and ELISA.

• Knowledge of statistical experimental design and data analysis is preferred.

• Knowledge of cGMPs as applied to process development and scale up is preferred.

• Excellent oral and written communication skills.

• Ability to work collaboratively in a team and matrix environment.

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.

Patient Support Specialist

SUPERVISORS

Manager of Patient Support & Reimbursement

DEPARTMENT

Market Access

DIRECT REPORTS

N/A

LOCATION

Berkley Heights

PREREQUISITES

Bachelor’s degree required. 2+ years of experience in hematology/oncology, pharmaceutical and/or healthcare industry preferred. RN, RPH, MSW, CPhT or billing experience is a plus. Bilingual, Spanish speaking preferred.

The Patient Support Specialist will be responsible for serving as a single point of contact for healthcare providers/patients for their reimbursement and access needs in his/her geographic area. The Patient Support Specialist will help patients and healthcare providers navigate insurance and financial related assistance. This position reports to the Manager of Patient Support and Reimbursement.

Responsibilities will include, but are not limited to, the following:

• Ensure access to all products across Hematology/Oncology franchise

• Educate internal stakeholders and external customers on breadth and depth of department service offerings

• Act as a reimbursement navigator for patients, healthcare providers and specialty pharmacies that opt into Patient Support service offerings for both oral and IV Celgene Hem/Onc products.

• Independently manage a case load within his/her geographic area and provide seamless coverage for other Patient Support Specialists’ case load when necessary.

• Accurately and thoroughly assess all patient needs and document all case notes

• Provide timely resolution to open cases

• Communicate with the patient/authorized representative, healthcare provider and specialty pharmacy regarding case-related updates and to appropriately manage expectations

• Ability to manage critical conversations with patients, healthcare providers and pharmacies

• Comprehensive assessment of each case to determine appropriate avenue to maximize patient access to Celgene products.

• Provide support to customers in the implementation of Celgene REMs programs

• Determine eligibility for Celgene Patient Assistance Program

• Provide information and education on Medicare Part D enrollment

• Identify alternative resources available, i.e. insurance or financial-related assistance

• Provide timely response to reimbursement/access related questions

• Develop and maintain a localized understanding of market access challenges. Act as subject matter expert and educate patients, healthcare providers and internal cross-functional partners.

• Effectively collaborate with a variety of internal cross-functional partners

• Develop and execute Celgene Patient Support business plan for accounts in assigned geographical area

• Plan and organize live or virtual Celgene Patient Support educational programs

• Establish goals and develop targeted plans

• Conduct educational presentations on reimbursement and Patient Support services

• Partner with market access field team to identify additional resources and discuss current payer and reimbursement-related trends

• Present to State Oncology Society meetings, industry conventions/seminars and patient advocacy groups

Skills/Knowledge Required:

• Bachelor’s degree required. 2+ years experience in hematology/oncology, pharmaceutical and/or healthcare industry preferred. RN, RPH, MSW, CPhT or billing experience a plus.

• Has knowledge of IV and oral product reimbursement, including but not limited to Medicare, Medicaid and commercial insurance carriers, Prior Authorization submissions/appeals

• Understanding of the healthcare industry, including both private and government payer landscape

• Utilize critical thinking to problem-solve access challenges

• Apply emotional intelligence

• Empathetic listening skills to interact effectively with patients and providers.

• Excellent written and verbal communication skills

• Ability to lead presentations that effectively impact understanding of key messages

• Proficient in MS Outlook, Word, PowerPoint, and Excel.

• Experience with salesforce.com CRM platforms preferred

• Ability to balance independent priorities with the priorities of the team/organization

• Ability to work in a fast-paced environment, multi-task and self-prioritize workload

• Proven experience resolving customer issues

• Works with all members of a team effectively

• A minimum of 10% travel required

• Bi-lingual, Spanish speaking 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.

MD preferably board certified in Hematology/Oncology.

8+ years industry experience strongly preferred, including expertise in the conduct of clinical trials in hematology/oncology.

He/she will be headquarters based in Princeton or Summit, New Jersey, USA, or Boudry, Neuchatel, Switzerland, and will provide scientific/medical expert input and support for Myeloid launches and approved products, as well as, compounds in various stages of clinical development in that therapeutic area. 

This individual will lead the design and implementation of integrated global medical plans, under the supervision of the Myeloid Leukemia Disease Lead, Global Medical Affairs, and in coordination with the cross-functional teams.

Together, they will take an ownership role in leading the design, planning and execution of BMS-sponsored medical affairs trials (Phases I, II, and III), early access and compassionate use protocols, as well as post-approval observational and interventional studies. 

He/she will also be responsible for the evaluation and support of investigator-initiated trials. 

He/she will represent Global Medical Affairs as needed, serving as a Myeloid Leukemia therapeutic area expert in strategic and tactical discussions and presentations with internal colleagues in cross-functional and cross-regional teams, as well as external experts and investigators.

Responsibilities will include, but are not limited to, the following:

• Strategic and Tactical Planning: Responsibility for Global Medical Affairs success
  • Launch plans for new products or new indication launches in the Myeloid franchise
  • Integrated evidence generation plans
  • Publication plans
• Responsible for the planning and timely execution of Medical Affairs Sponsored Trials, ensuring excellent standards on compliance, quality, timeliness, budget, and Medical governance. Lead various activities of Global cross-functional teams relating to medical affairs.
• Represent Global Medical Affairs as Myeloid Leukemia area expert in both internal and external venues including regional and Global cross-functional teams, clinical sub-teams, advisory boards, steering committees, investigator meetings, congresses and local symposia.
• Collaborate with Medical Affairs colleagues to define, guide and execute Myeloid Leukemia therapeutic regional strategies and tactics with appropriate use of resources.
• Provide high quality medical input and review of:  Disease strategy plans, abstracts, posters, slides, manuscripts, educational materials, IIT protocols, steering committee and advisory board meeting objectives, Medical information letters, Commercial Brand plans, Scientific educational grant requests and patient advocacy grant requests
• Track priority Medical Affairs tactics and performance to goals/budget
• Perform research and analytics and provide recommendations to support quality medical decisions regarding clinical research, consultancy, and internal planning.
• Partner with Scientific Communications on developing timely publication strategy and plan, gap analysis, and key messages.
• Assist with data summaries, preparation for site visits/corporate visits presentations.
• Interaction with key stakeholders, as a therapeutic area medical strategy expert.

Internal, including and not limited to:

• Medical Affairs partners in different therapeutic areas
• Global Medical Affairs Leadership
• Marketing
• Market Access
• Clinical R&D
• Statistics
• Translational Research
• Regulatory Affairs
• Project Leadership

External, including and not limited to:

• Investigators, KOLs
• Global steering committees
• Scientific Advisory Boards
• Advocacy groups
• Cooperative groups

The ideal candidate will have:

• Medical Degree, preferably board certified in Hematology/Oncology
• Expertise in hematological malignancies is a strong plus
• A minimum of 8 years industry experience strongly preferred
• Expertise in the conduct of clinical trials in hematology/oncology
• Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies
• Proficiency in critical data review and interpretation
• Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 discussions with thought leaders
• Knowledge/application of data sources, reports and tools for the creation of solid plans
• Regular travel will be required as needed

Expected Areas of Competence:

• Medical lead of clinical studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional BMS colleagues
• Ability to present clearly in scientific and clinical settings
• Conducts medical data review of trial data, including eligibility review.
• Responsible for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
• Responsible for assessment of key safety-related serious adverse events in partnership with GPVE and oversees safety narratives.
• Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations).
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training for same
• Provides medical accountability and oversight of a group of studies
• Partners with CS to support executional delivery of studies (eg, 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 (TLs) 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 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, protocol specific training, to support study team, investigators, and others

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

• CDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy

• Serves as the clinical point of accountability for the Development Team and is responsible for the overall clinical development plan for asset(s) in one or more indication(s)/tumor type(s)

• Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals

• Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs)

Position Responsibilities

• Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication

• Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians

• May serve as CTP as necessary

• Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles

• Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents

• Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct

• Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function

• Partners with Worldwide Patient Safety physicians in the ongoing review of safety data

• Serves as the (co-)leader of the cross-functional Clinical Development Team

• Provides clinical leadership and disease area expertise into integrated disease area strategies

• Partners closely with KOLs in specific indications

• Serves as Primary Clinical Representative in Regulatory interactions

• Evaluates strategic options against a given Target Product Profile (TPP)

• Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed

• Sets executional priorities and partners with CTP and CS to support executional delivery of studies

• Accountable for top line data with support of CTP, CS, and Statisticians

Degree Requirements

• MD preferably with appropriate sub-specialty training as appropriate

• PhD, Pharm D or other health related scientific field with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge

• At least 10 years of relevant experience

Experience Requirements

CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes:

• Able to synthesize internal and external data to produce a clinical strategy

• Able to ensure that the clinical program will result in a viable registrational strategy

• Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts

• Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio

• CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent

• Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues)

Key Competency Requirements

• CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)

• External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS

• Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)

• Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables

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.

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.

Bristol Myers Squibb Ireland

Bristol Myers Squibb (BMS) has been in operation in Ireland since 1964, employing over 600 people across a range of activities and business units.

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility, is part of the Global Product Development and Supply (GPS) network. This state of the art facility produces multiple therapies for the company’s growing biologics portfolio and plays a central role in Bristol-Myers Squibb global manufacturing network. The Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work for 2017, 2018 and 2019. 

Many of the global business services, including Commercial, the European Treasury Centre, Global Bio Lab and Global Logistics are based on the island of Ireland. Ireland is also home to External Manufacturing’s global headquarters, the organization responsible for the management of manufacturing and reliable supply across the Bristol-Myers Squibb global network. This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites.

The Role

BMS Cruiserath Biologics is seeking to recruit a permanent QC Separations Analyst to join the QC Separations Laboratory, the function of which is to support drug product and drug substance release testing.  The QC Separations Analyst will be involved in assisting in the establishment of laboratory operations, performing testing of samples and performing laboratory duties in accordance with cGMP regulations.

Key Duties and Responsibilities:

• Performing release testing for biological products
• Assisting in updating and issuing documentation, including SOPs, as required.
• Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports.
• Accurately documenting laboratory work.
• Execute and assist in technical transfer and co-validation activities.
• Assisting with qualification of laboratory instruments.
• Data review based on demonstrated proficiency on assays.

Qualifications, Knowledge and Skills Required:

• 1-2 years’ experience in a regulated biopharmaceutical laboratory is essential. HPLC/UPLC and Empower experience is required. 
• The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline. 
• The successful candidate must demonstrate an ability to work independently in assay and recognize anomalous trends or results.
• Must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines. Excellent communication and the ability to work in a team based collaborative environment are required.

What’s important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

• Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
• Innovation: We pursue disruptive and bold solutions for patients.
• Urgency: We move together with speed and quality because patients are waiting.
• Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
• Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
• Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

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.