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.  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.

• Please note: This Regional position primarily supports the Seattle, WA area.

• o    Serve as the site facing role for clinical operations at sites within the region.

  o    Expedites the pre-study and study initiation processes including conduct of Pre-Study Evaluation and Site Initiation Visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to train site personnel regarding the protocol and applicable regulatory requirements.

  o    Identifies, evaluates and recommends potential investigators/sites on an on-going basis within assigned region.

  o    Critically reviews and analyzes site activities through targeted risk based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable BMS SOPS, subject protection and ICH and/or FDA GCP Guidelines and other local regulations.  This includes but is not limited to:  Manage multiple protocols, across therapeutic areas but primarily oncology.  This may require limited travel, based upon assigned site location and or/geographic territory.  Significant travel outside of region is rare.

  o    Proactively communicates, and escalates with all internal and external stakeholders any significant issues identified at study sites while developing corresponding mitigation strategies and solutions, including the following activities: root cause analysis, corrective, and preventative action plans.

  o    Ensures timely entry and quality of data submitted from study sites.

  o    Supervises overall activities of site personnel over whom there is no direct authority and motivates and influences site personnel to meet study and timeline objectives.

  o    Ensures documented follow-up to all outstanding issues within monitoring management system ensuring appropriate issue escalation to line manager and project team members as necessary.

  o    Facilitates, as needed, internal regulatory compliance audits and Health Authority inspections for assigned sites.

  o    Prepares and submits monitoring and management reports in a timely, accurate, concise and objective manner.

  o    Initiates, develops and grows professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders.   

  Position qualifications/requirements:

  o    2-5 years of clinical research or pharmaceutical developmental experience, of which at least 2 years must be clinical research monitoring. Oncology Experience preferred.

  o    At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution.

  o    Thorough knowledge of ICH/FDA guidelines and understanding of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US.

  o    Thorough technical working knowledge of Electronic Data Capture, Electronic Medical Records and computer based systems.

  o    Understanding of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)

  o    Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills. 

  o    Exhibits a high level of flexibility and adaptability for changing priorities and processes.

  o    Employs strong fiscal management of departmental budget by independently managing travel and functional expenses.

  o    Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time.

  o    Demonstrates project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders.

  Locations

  Seattle, WA - US

Director, US Commercial Biomarkers and Diagnostics

What we are looking for:
A strong leader with a passion for driving improved patient outcomes through precision medicine for patients living with cancer.  This individual will have point responsibilities on our US Commercial Biomarkers & Diagnostics team and lead the biomarker strategy and tactical development for the US Oncology organization.  This individual will be responsible for biomarker and diagnostic readiness in the US market for all oncology indications and products including Opdivo.

Your team:
The Director, US Commercial Biomarkers and Diagnostics reports to the US Commercial Biomarker and Diagnostics Lead in the US Oncology Commercial organization.  This individual will work closely with our US Brand Leads, Tumor Leads, US Medical Biomarker team, Access Strategy team, Business Insights and Analytics, WW Commercial/Medical Biomarker and Pharmacodiagnostic teams as well as diagnostic partner companies and external oncology/pathology customers. 
Primary Responsibilities:
•    Develop BMS leadership capabilities in the area of Precision Medicine, Biomarkers and Diagnostics in the US market
•    Provide commercial leadership for all strategies and tactics pertaining to emerging biomarkers and companion diagnostics for our immuno-oncology brands and pipeline assets
•    Act as the US Commercial point for relationships and launch strategies with external partners and diagnostic companies.
•    Prepare the US market for the adoption of a new biomarker or diagnostics to support new indications and launches within oncology - lead go-to-market strategies, tissue journeys, testing assumptions, message development, market insights, forecasts, etc
•    Support and educate the Brand and Tumor Leads in all aspects of biomarkers and diagnostics and act as the subject matter expert for biomarker commercialization in the US 
•    Lead and develop a team of 3 marketers to create a biomarker center of excellence
Qualifications and Experience we look for in a candidate:
The position will require a strong understanding of the role of precision medicine and biomarkers from a commercial perspective.  Strong matrix leadership and collaboration skills required.  Ability to shape direction and pave new paths in an emerging and undefined category required.  Passion for oncology required.
•    Experience in oncology commercialization and biomarker / diagnostic space is required. 
•    Minimum of 6-8 years of combined experience in the pharmaceutical and/or diagnostic industry.
•    Diagnostic launch experience preferred
•    US commercial experience preferred
•    Strong leadership and collaboration skills required.  Strong verbal communication and presentation skills required.
•    25% travel including limited weekend travel.

Summary

Lead a BMS matrix team to develop an aligned strategy for Real World Evidence and Health Economics and Outcomes Research (HEOR) studies to demonstrate the value of BMS products in a meaningful way to healthcare customers. Make decisions on selecting external organizations and researchers with appropriate expertise for research collaborations. Effectively lead research and manage projects from concept through full execution, including reporting the evidence at scientific congresses, in peer reviewed publications, and proactive/reactive BMS communication tools. Demonstrate ability to support and influence internal BMS stakeholders. Be effective in demonstrating the value of HEOR initiatives so that funding can be secured. Execute RWE/HEOR studies in a scientifically rigorous way, while appropriately addressing business needs within the legal and regulatory requirements. Serve as an internal RWE/HEOR expert helping to develop product value propositions by incorporating evidence relating to health services research to achieve market access. Be viewed as an internal RWE/HEOR expert who is fully integrated into the BMS matrix team and provides critical input into development of effective communication tools and programs for optimal market access. Strive to demonstrate BMS behaviors of Passion, Speed, Innovation, and Accountability.

Qualifications

Advanced degree in health science, e.g. PhD, PharmD, MS, MPH.

Eight plus years previous experience working in outcomes research, health economics or epidemiology in the pharmaceutical industry.

Real World Evidence/observational study experience and study design expertise

Real World Evidence database experience and data interpretation

Ability to lead a cross functional team and influence without formal authority.

Ability to understand, interpret, and make recommendations concerning the evolving US market.

Effective problem-solving skills.

Strong communications skills.

Previous experience of executing multiple research projects simultaneously.

Relevant scientific experience in pharmaceutical industry.

Previous experience in publishing scientific data with strong scientific publication track record.

In depth understanding of healthcare economics, epidemiology, quality of life and clinical research.

Strong understanding of US payer and market access challenges.  

In depth understanding of statistical methods and tests. Strong knowledge of pharmaceutical development and product promotion.

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.

The Clinical Genetics and Genomics team is seeking an innovative and highly motivated scientist to join our world-class team. The selected scientist will be responsible for genomics biomarker assay development, optimization, validation and execution of biomarker analysis for BMS translational research and clinical programs. The scientist must have a strong background in genomics as well as experience with and understanding of immunology or immunoscience related disciplines.

Key Responsibilities:

• Assay design and development: Understand program biology requirements working with the biomarker and program leads and help develop the genomics biomarker strategy and execution plan working with the technology leads.
• Design, develop, optimize genomics and genetics biomarker assays and develop and execute the validation of these assays for clinical trial assays.
  • Key assay profiles likely to include NGS or qPCR based gene expression systems, genotyping or variant analysis utilizing NGS or qPCR or other methodologies.
• This is a lab based position with a significant opportunity to interface with program teams to understand program requirements and background, assay and analysis requirements, analysis timelines, analysis needs
• A significant part of time will be spent assisting development and analysis of validation data. A strong understanding of assay validation and fit for purpose assay validation requirements will be essential.
• In case of outsourced studies, the incumbent will provide oversight of assay development and execution of sample analysis at the vendor.
• Help to draft experimental plans, validation reports, work instructions, technology transfer documents, study summaries and SOPs.
• Actively participate in internal/external collaboration, portfolio management groups and clinical study and biomarker execution teams.
• Providing subject matter expertise for clinical and program teams as required.
• Accurate record keeping of experiments and procedures
• Observe technology developments and innovate on new methodology per team requirements.
• Work closely with data analysis teams as well as sample management and clinical operation teams on programs.

Minimum Requirements:

• Experience in genomics based studies of immunooncology, oncology immunology or related fields.
  • Masters Degree with 5 yrs experience or Phd with 2 years experience with relevant work experience.
  • Experience in clinical assay development for gene expression profiling assets.
• Understanding of fit for purpose genomics assay validation principles for clinical assays.
• Experience with genomics (NGS, qPCR) assay development, validation, troubleshooting, and reviewing of run QC data.
• In-depth knowledge of different genomics platforms and technologies (for the clinic).
• Familiarity with NGS and qPCR data analysis and QC to develop a strong interaction with the data analysis team.  
• Technical expertise with molecular technologies, including but not limited to: NGs, single cell NGS, PCR, quantitative real-time PCR, digital PCR, NanoString,and other relevant methodologies.
• Must have strong organizational and interpersonal skills with excellent leadership skills.
• Must be self-motivated, with demonstrated ability to work independently and learn quickly.
• Must be goal oriented and focused on completing work on time.
• Thrive in a highly interactive, fast-paced and dynamic team environment.
• Must be able to quickly adapt to changing priorities and work well in fast pace environment and under pressure.
• Ability to mentor others on technical operating systems
• Ability to independently review and understand project proposals/plans
• Ability to work in a matrixed team in a high pressure environment.
• Excellent communication skills with ability to serve as key contact for program teams.
• Must have excellent organization and record keeping skills
• Must be highly resourceful and work across matrix teams.

Preferred Qualifications:

• Previous industry experience is a plus
• Previous experience in a clinical laboratory setting is a plus
• Bioinformatics and data interpretation fluency and ability to engage with Bioinformatics team to appropriately QC and query datasets.
• Understanding of design of experiments, randomization of samples for clinical analysis. 

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.

Job Description:

The BMS Clinical Genetics and Genomics Group is seeking a NGS Research Scientist to lead the development, validation, implementation, and growth of Next Generation Sequencing (NGS) technology to support the company’s pipeline across all active therapeutic areas with an emphasis on Oncology and Immunoscience. The group is responsible for the application of relevant technologies to measure specific genetic or genomic endpoints in clinical studies which support 1) mechanism of action hypotheses, 2) pharmacokinetic/pharmacodynamic evaluations, and 3) patient stratification or 4) novel biomarkers related to clinical response. He/She will liaise closely with various stakeholders to ensure implementation of the appropriate genetic and genomic assays in early clinical studies and serve as a genomics subject matter expert for clinical programs. The position will involve leading and mentoring a team of  scientists in a direct or matrix mentoring role.

Job duties:

• Drives the implementation and growth of NGS technology, supports ongoing development, validation and troubleshooting of NGS assays, including targeted DNA-seq and RNA-seq, WES, and WGS.
• Oversees operations of different NGS workflows; from sample preparation, library construction, data generation, data processing to interpretation of results, ensuring a high level of quality and reliability of generated results.
• Implements data processing and analysis workflows in alignment with colleagues in bioinformatics bioinformatics pipelines, and data storage procedures in collaboration with internal and external multidisciplinary teams.
• Effectively manages available resources, distributes assignments and delegates workload as needed to achieve timely execution of projects, works with cross functional teams (internal and external teams) to execute plans and set deliverables.
• Serves as a subject matter expert for NGS technology, provides guidance on experimental design, method or platform selection, and data management to address a specific need.
• Educates laboratory staff and/or contractors, conducts hands-on training, and delivers internal and external presentations.
• Learns various NGS platforms, stays on the top of the scientific and technical innovations, and follows new trends and developments in genomic technologies to uphold BMS’s competitive advantage.
• Drafts experimental plans, validation reports, work instructions, technology transfer documents, study summaries and SOPs.
• Actively participates in internal/external collaborations, portfolio management groups and clinical study and biomarker execution teams.

Minimum requirements:

The candidate must have experience in clinical genomics and genomics biomarker teams  in a relevant scientific field, such as molecular biology, genetics and genomics, biochemistry, or other related disciplines, ideally in a pharmaceutical, biotech or clinical diagnostics industry.

• Masters Degree with 7 years experience, PhD with 5 years experience or a Postdocural
• Must have at least 2-3 years of documented hands-on experience with clinical and diagnostic NGS assay development, validation, troubleshooting.
• Must have an in-depth knowledge of different NGS platforms and technologies.
• Technical expertise with molecular diagnostic tests such as qPCR, PCR, digital PCR, Nanostring and other relevant genomics diagnostic platforms are highly desired.
• Must have strong organizational and interpersonal skills, must display excellent leadership and people skills, and demonstrate ability to work collaboratively with others in a highly matrixed environment.
• Mentoring and team building abilities will be highly valued.
• Must be familiar with different NGS software platforms, bioinformatics pipelines and NGS data processing and interpretation solutions.
• Ability to analyze and QC data in conjunction with a dedicated bioinformatics team will be desirable.
• Must be self-motivated, with a demonstrated ability to work independently and learn quickly.
• Must be goal oriented and focused on completing work on time.
• Must be able to quickly adapt to changing priorities and work well in fast pace environment and under pressure.
• Must possess good communication and presentation skills.

Bristol-Myers Squibb R&D is a science-driven, passionate organization determined to discover, develop and deliver medicines that have the potential to transform the lives of patients and establish new standards of care in areas of high unmet need. Patients’ needs and scientific discovery are our driving force.   The new Bristol-Myers Squibb research site in Cambridge’s Kendall Square will position our scientific team in the heart of a vibrant ecosystem of world-class science, innovation and business opportunities.  Our scientists will focus on novel targets and pathways for tumors that are refractory to current Immuno-Oncology therapies. These are significant challenges that will require innovative solutions from the biopharma, biotech, and academic communities.

Roles and Responsibilities

We are seeking a talented BS/MS level Senior Research Scientist, who has extensive experience in cellular immunology and immune-oncology. The ideal candidate has a background in one or more areas of immunology, including myeloid and T cell biology, antigen presentation, and immune cell trafficking. The candidate must have an extensive background in flow cytometry, include multi-parameter immunophenotyping, panel development, and FACS sorting. The candidate should also be familiar with FlowJo and other flow analysis software and have strong analytical capabilities. Additional qualifications include prior experience utilizing cellular immunology assays including proliferation, suppression, cytotoxicity, migration, and cytokine secretion. The ideal candidate should have experience working with human tissues including, blood, blood products, and tumor tissue. Experience in processing tissues for flow cytometry and downstream assays, including bead sorting, PBMC isolation, and tumor dissociation is required. Prior clinical-facing experience is a plus. This position includes a blend of assay development, exploratory work, and routine clinical sample processing and downstream acquisition and analysis. Given the sporadic nature of clinical sample intake, this position requires flexibility in working hours. The ideal candidate will be capable of translating a scientific question into a series of experiments, performing end-to-end experiment planning, setup, execution, analysis, and interpretation of results. The qualified candidate should be capable of working within a fast-paced and highly-matrixed multi-disciplinary research environment.

Qualifications / Essential Skills

• BS/MS with 10+ years of experience in cellular immunology, flow cytometry, and immune-oncology, with 3+ years in a biotechnology and pharmaceuticals setting
• 1-2 years of experience working with assistant/associate researchers in the lab
• Experience using FlowJo and other flow analysis software, and strong analytical capabilities
• Hands-on experience and practical knowledge in cellular assays, including proliferation, suppression, cytotoxicity, migration, and cytokine secretion
• Experience in sample processing, including bead sorting, PBMC isolation, and tumor dissociation
• Prior experience as part of a multidisciplinary team in an academic or industry setting
• Excellent written and oral presentation skills and flexibility and proactive approach to taking on a multifunctional role within a large cross-function team.
• Level-headed, multitasker who embraces challenge

• We follow the science and we’ll continue to invest in translational medicine research, deepen our understanding of disease biology and uncover insights about predictive biomarkers with the ultimate goal of making precision medicine a reality for more patients.

Summary

The PDL role embodies 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, optimize medical practice and drive appropriate adoption of BMS medicines. The PDL role is field-based and it is anticipated that an PDL will spend a minimum of 60-70% of their time in the field with external customers.

The primary role of the PDL is to develop relationships and maintain contacts with pathology Healthcare Providers (HCP), other diagnosticians and reference labs within their healthcare system. The PDL will act as a clinical and scientific resource responsible for the delivery of scientifically-based information in support of approved oncology products and the accompanying diagnostic testing information. The PDL will provide scientific education to pathology HCPs on the role of diagnostic testing for PD-L1 and other assigned biomarkers, and the role this testing plays in relation to immuno-oncology agents.

External Environment and Customer Focus

Develop and maintain peer-to-peer relationships with critical stakeholders including thought leaders (TL), and other HCPs specializing in oncology, immuno-oncology, and pathology. The PDL will use various channels for interactions (1:1, group presentation; remote, etc).

Demonstrate proficiency in using available scientific resources and presentations. Effectively present information to TLs, HCPs and reference labs 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 TLs, HCPs and reference labs to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, and diagnostic testing. Understand the competitive landscape and actively prepare to address informational needs of customers.

Collect and provide meaningful medical insights and/or impact by communicating these back to the medical and commercial organizations to be actioned in support of strategy development.

Identify opportunities to partner with HCPs on disease state initiatives, collaborative research projects, and investigator sponsored research (ISR) of interest and in alignment with BMS strategic objectives

Support clinical research activities that include complex specimen procurement/processing, translational medicine, and biomarker/diagnostic components

Contribute to the Medical Plan

Adopt institution/account planning approach and contribute to cross-functional institution/account plans, as applicable.

Contribute to development and delivery of scientifically meaningful medical programs to pathologists on immuno- oncology, focusing on biomarker testing, in line with the local Medical and Field Medical plan.

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, as applicable.

Required Experience

MD, PhD preferred (PharmD, PA, NP, RN will be considered) with oncology and/or diagnostics industry experience

A minimum of 2 years working in a clinical or pharmaceutical environment

Knowledge Desired

Disease area knowledge and an understanding of scientific publications

Knowledge of a scientific, clinical, and diagnostic testing areas

Previous commercial-side industry background

Demonstrated expertise in drug information communication

Knowledge and understanding of PhRMA Code, FDA, and IOG guidelines

Excellent English language skills, spoken and written

Travel required

Experience Desired

Ability to work independently and, to integrate and work in a cross functional network, including field-based work

Translating scientific, clinical, and diagnostic testing data into an understandable and valuable form to help physicians best serve their patients

Good communication and presentation skills to present scientific, clinical, and diagnostic testing data to 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

Demonstration of the BMS Core Behaviors

Essential Qualification

Ability to drive a company-provided car is an essential qualification of this position. Candidates must be able to drive a BMS-provided vehicle between locations (often great distances apart), and arrive at each location ready and able to enthusiastically and efficiently demonstrate an applied knowledge of pertinent health care industry trends. Candidates must possess a high level of ethics, integrity and responsible and safe driving history.

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.  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.

​

** The Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate **

JOB DESCRIPTION

• Work with the Program Lead and team members to translate the FDT strategy into trial options and protocols
• Clinical monitoring of one or more studies
• Medical Data Review (and data cleaning support as appropriate) of ongoing studies working with Clinical Operations and Data Management.
• Addresses relevant clinical queries from study sites with documentation in eTMF
• Identify and builds relationships with investigators
• Contributes to DSURs and PSURs
• Supports generation and coordination of clinical documents and deliverables in support of regulatory filings
• Work consistently in a matrix environment
• MD, PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge
• The position is based in the Princeton, NJ area

JOB REQUIREMENTS

• Responsible for the study timelines in a cross-functional matrix protocol team
• Responsible for the clinical development activities from site(s) initiation to study discontinuation
• Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements
• In collaboration with GRS and GPV&E, designs and implements safety monitoring plans
• Interprets clinical data and makes appropriate decisions and recommendations
• Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions
• Work with the Program Lead, team members and governance bodies to translate the FDT strategy into trial options, protocols and action plans
• Work with the Program leads to author clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview
• Addresses relevant clinical queries from study sites; and authors responses to study related HA and IRB questions

ESSENTIAL LEADERSHIP BEHAVIORS

• Identify and builds relationships with study investigators
• Is seen and acts as the study expert by the site personnel
• Ability to work and communicate efficiently with internal partners in the US for positions located outside the US
• Identify and builds relationships with principal investigators
• Identify Thought Leaders and use them for inputs in clinical strategy and protocol design
• Maintain a strong medical/scientific reputation within the disease area
• Contribute to Health Authority interactions as a Medical Monitor on assigned clinical studies
• Share specific clinical strategies with other clinical teams
• Study-specific clinical design and execution
• Manage communication with key stakeholders (senior)

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

• Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry - e.g. monitoring)
• Management of one or more uncomplicated studies and preparation of regulatory documents
• New entrance to pharma: out of fellowship/ new to industry
• Limited clinical research experience (substantial academic research experience could potentially substitute)

DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

• Relevant clinical research experience (relevant academic research experience could potentially substitute)
• Has a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock
• Has a history of handling multiple, complex, studies in parallel
• Has a history of prior meaningful participation in regulatory submissions
• Has a history of strong interaction with thought leaders
• Proven team leadership capability
• Performs as an individual contributor
• Identifies when an issue is present and begins to address

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.  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.

Key Responsibilities and Major Duties:
• Senior-level clinical operational leader who drives and leads the successful execution of all operational components of a large-scale global clinical program using strong project management, leadership and organizational skills.  Excellent communication skills required.
• Accountable for operational execution across approximately 10-15 clinical trials and addresses and manages risks and issues.
• Contributes to the development of clinical operational strategy and shapes the clinical development plan.
• Represents GCO on the Development Team and serves as the key GCO operational point of contact for the program and respective clinical trials. 
• Drives the development of program level documents and plans and effectively leads a large global team of individuals assigned to the program. (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)Supervisory Responsibility (List job titles of positions that report directly or indirectly to this position and indicate nature of relationship):Provides Matrix Management oversight for Protocol Managers (PTMs) and Clinical Scientists (CS)Key Stakeholders/Contacts – describe this position’s key internal matrix relationships and key external stakeholders/clients:Development Team (DT), Operations Team, Medical Surveillance Team (MST), Global Regulatory Sciences and Biometrics (GRS+B), All GCO Functional Groups, Clinical Supply Operations (CSO), Collaborative Sciences Research and Operations (CSR+O), Global Quality and Regulatory Compliance (GQRC), External Thought Leaders, Contract Research Organizations (CROs), Oncology, Marketed Product, Medical,  Field Medical, and  Country Medical Heads/Directors  and leadership team members, Advocacy Groups, Investigational Sites, Investigators of Investigator Sponsored Research, External Vendors

Competencies – knowledge, skills, abilities, other

Program Management

• Develops project standards and ensures consistency and efficiency across the program
• Manages a disciplined approach to accurate documentation of the team’s work
• Consistently uses the PMF principles (initiate, plan, execute, control and close) to manage project progress
• Leads and oversees cross-functional teams to ensure successful and efficient execution of studies from start up to final CSR or Regulatory submission
• Integrates lessons learned across the project
• Supports the team in the using the Risk Based Monitoring methodology
• Advises and serves as an expert resource for a broad range of organizational-related issues requiring clinical knowledge
• Acts as point of contact for operational expertise for FDT (Full Development Team)  members and development partners
• Works with GCO functional management and across R+D to secure necessary resources to adequately support the program
•  Achieves results by effective mobilization, development and utilization of resources
• Provides input (as needed) to Health Authority submissions

Operational Leadership/Decision making

• Consistently makes operational decisions in a timely manner
• Uses expert judgment to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities
• Acts decisively to address team challenges
• Contributes to business strategy from an operational perspective
• Leads/co-leads the Clinical Development Team (CDT) and Operations Team meetings; active participant and GCO representative on the FDT
• Facilitates issue escalation and resolution in collaboration with other functional areas
• Actively contributes to issue identification and strategy discussions at senior level meetings

Stakeholder Management

• Addresses the concerns and needs of stakeholders and manages stakeholders’ expectations
• Appropriately seeks input before making a decision
• Facilitates issue resolution and communication/collaboration with stakeholders and other functional area team members
• Builds alliances to gain key stakeholder support, buy-in and ownership
• Builds and nurtures partnerships with internal and external team members that develop and maintain trust
• Partners with business leaders to resolve competing priorities and issues related to stakeholder management

Communication

• Provides vision to build partnerships across functional area leadership
• Consistently demonstrates positive attitude about the team’s ability to deal with challenges
• Drives issues to resolution; communicates to insure that issues have been worked through to completion
• Applies change management principles  to support communication and implementation of integrated change
• Demonstrates diplomacy when interfacing with other functional areas, CROs and other outside vendors.
• Frequently communicates program status to different levels of stakeholders

Development of team members

• Consistently provides accurate, motivating and constructive feedback and coaching to team members
• Invests time in getting to know others to understand their attitudes and views; learns others’ style to interact effectively
• Accommodates cultural differences
• Builds high performance teams to align program and company objectives, assesses training needs and  recommends training where needed
• Partners with functional management to assess skill sets of and set objectives for each team member to enhance developmental opportunities and career development

• Software that must be used independently and without assistance (e.g., Microsoft Suite)

BMS Systems: ECLIPSE, CARA

Enterprise Applications: SharePoint, SAP, Microsoft Suite

BMS BioPharma Behaviors Required

• Passion
• Innovation
• Speed
• Accountability

Working Conditions

• Travel Required (nature and frequency) - Occasional for meetings and/or training sessions. Mostly inter-site travel
• Overnight Absences Required (per typical month) - 2-4 overnights per month

• Describe exposure to any hazards/disagreeable conditions in the work environment - Not applicable

Experience in working in collaborations or with co-development partners preferred

Degree/Certification/Licensure

BS/BA Degree with approximately 10 years of pharmaceutical or biotech experience in a clinical drug development setting.  Advanced degree is preferred.

• Experience – Responsibility and minimum number of years

• Candidate must have a minimum of a BA or BS Degree with approximately 8-10 yrs. of experience in clinical drug development. 
• Strong leadership competencies and influencing skills with senior leaders and cross functional leaders. 
• Effective oral and written communication skills to influence, inform and guide a large scale global operational team.
• Broad clinical operational experience and strong project management skills.
• Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.

D07- Clinical Operations Lead

Minimum of 8 years of direct experience independently leading and managing global clinical trials in the Pharmaceutical industry

D08- Senior Clinical Operations Lead *

At least 10 years of direct experience with independently leading and managing global clinical trial program(s) plus 3-5 years in a senior leadership position directing the operations of a large-scale global team and developing and mentoring junior colleagues

*key considerations: breadth of experience in complex clinical trials, leadership skills, adaptability, level of independence

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. 

Key Responsibilities and Major Duties:

• Manages all steps in a clinical trial execution from country profiling, hub commitment, site feasibility and site selection, target setting, study start-up, site activation, study recruitment & maintenance, database lock to final study closure.
• Responsible for managing the submission of initial and ongoing documents to the relevant IRB/MOH or other regulatory bodies for approval or acknowledgment
• Coordinates Hub cross functional teams and acts as the main point of contact for a Hub with the global study team
• Coordinates Investigator meetings, internal training requirements and coordination of ongoing training of Investigators & site personnel
• Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
• Performs periodic review of the eTMF to ensure site level documents are appropriately filed.
• Ensure Hub is Inspection ready and prepares the CAPA for Hub audit level findings. Drives CAPA review and implementation.
• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Ensures database locks are met at a site and appropriate site management support for central teams during Database Locks
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
• Ensure Clinical Trial Managements Systems are maintained appropriately and access to eDC and vendor systems is available for the Hub and clinical trial site personnel is available  
• Clinical Data Listing review is performed at the assigned timepoints according to the Data Review Plan
• Ensuring Post Drug Access is available for patients where appropriate  

List of minimum requirements:

• A University degree in Life Sciences, Pharmacy, Nursing or equivalent.
• Demonstrates a thorough understanding and knowledge of all steps in the clinical research process.

• Knowledge of GCP, ICH as well as local regulations.
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
• Understands how the issues of a single study can impact the overall project and contributes to establishment of best practices through coaching and feedback
• Associate Clinical Site Manager – 1-2 years
• Clinical Site Manager – 2-3 years industry related experience
• Senior Clinical Site Manager - 5 years of industry related experience

Competencies – knowledge, skills, abilities, other:

• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
• In depth knowledge and understanding of clinical research processes, regulations and methodology
• Demonstrated organizational and planning skills and independent decision-making ability
• Demonstrate ability in planning, problem solving and time management
• Understanding of BMS business process and working practices.
• Ability of critical thinking and risk analysis.
• Skilled in the use of technology
• Effectively applies project management skills, uses available tools and systems to gather information needed to manage site activities, generate reports and to provide feedback to the appropriate BMS team members.
• Adapts well to ambiguous and complex work environment, balancing multiple priorities. Able to multi task, manage time and prioritize effectively.
• Good oral and written communication
• Fluent in English