FP&A Manager Benelux leads FP&A activities and manage the country FP&A Managers for Belgium & Netherlands. He is the key point of contact for FP&A related queries, supporting Finance Director and cluster leadership team.

Key responsibilities & Major duties

• Lead FP&A Benelux team and manage the country FP&A Managers for Belgium & Netherlands. Provide day to day directions. Drive team development in terms of financial proficiency, business knowledge and external environment. Ensure regular coaching and lead FP&A development.
• Provide financial support to the local Business leaders, provide options and insights to drive financial results
• Act as primary contact for all financial queries related to area of responsibilities coming from regional HQ, business unit directors and other internal & external business partners across all areas of the business.
• Support Head of Finance Benelux in trend anticipation and risk assessment. Contribute to recommendations and contingency to meet financial and business objectives
• Provide timely information and analysis to feed decision process. Consolidate Benelux cluster management reporting. Ensure accurate, timely and compliant reporting.
• Liaise proactively with all related stakeholders to gain insights on Business dynamics and financial implications.
• Drive Planning process including budget and quarterly updates within area of responsibility. Ensure accuracy and robustness of package submission. Ensure high level of financial stewardship by making business partners aware of policy & procedure requirements.
• Actively contribute to regional finance improvement initiatives

Competencies – knowledge, skills, abilities, other

• Excellent oral, written and interpersonal communication skills.  Ability to interact with local Senior Management.  Strong presentation skills.
• Proven leadership skills in team management
• Track record of achieving results in a matrix organization. Strong in alignment and collaboration.
• Flexibility & adaptability.
• Ability to keep helicopter view and drill to appropriate level of details, hands on attitude.
• Strong experience in driving resource allocation and present financial advice in the form of options
•  Contribution to successful implementation of a global/regional initiatives.
• Mastery of financial analysis, modeling, processes (budget, strategic planning) sufficient to train and develop others.
• Knowledge of distribution, and marketing processes.
• Thorough understanding of operational business strategies and issues. Ability & confidence to challenge across levels of the business.

Experience – Responsibility and minimum number of years

• Experience of working in an international Finance environment for at least 10 yearsand in a managerial position for at least 3 years.
• Full knowledge and experience of general Finance and how BMS Pharma systems work  (budgets, projections, actuals and supporting systems) 
• Team Leadership, ability to drive process improvement and enhanced finance value.

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.

Within the Global Data Management and Centralized Monitoring organization, the Global Standards team works with stakeholders across BMS to ensure data is collected and delivered in a standardized manner to promote efficient and quality analysis and submissions.  The Global Standards Team Lead will manage the team, providing functional oversight and career management and will be the primary contact point for internal and external stakeholders.  The Global Standards Team Lead will also process a portion of the standards requests which are submitted.

Global Clinical Standards Team Lead is responsible for:

• Lead the Global Standards Team work activities, including directing the work, optimizing the process/roles/tools, and making sure standards requests are being completed efficiently and effectively
• Provide career management for the Global Standards Team members, developing team members and providing opportunities in line with their career growth
• Lead collaborations with groups within Global Data Management & Central Monitoring (GDMCM) and with internal stakeholders to ensure standards are being evaluated, governed, and implemented effectively
• Lead the efforts to evaluate industry best practices in the areas of study and data management, data tabulation and analysis & reporting, and identify standardization development or improvement opportunities.
• Develop and maintain existing standards used in support of clinical trials managed internally and by external partners, primarily in Immuno-Oncology, including providing recommendations on changes or new standards to data chain co-chairs taking into account various stakeholder needs while ensure regulatory and BMS best practices are followed.
• Partner with functional area stewards to establish and maintain processes for ensuring alignment across the data chain and associated systems.
• Participate in GDMCM and company wide initiatives, including taking leadership proles in these initiatives as needed

Job Requirements:

• Minimum of Bachelor’s degree required
• 5-10 years of experience in pharmaceutical industry of which 5 years have been in Clinical Data Management related to startup, conduct, and reporting for clinical trials.
• Demonstrated ability to manage and lead high-performing multidisciplinary teams and build alignment across functional areas for both drug programs and continuous improvement projects. 
• In-depth experience in industry standards (e.g. CDISC) in either the collection (CDASH), tabulation (SDTM) or analysis (ADaM) models.
• Experience interpreting Health Authority regulations with a strong compliance background.
• Broad experience in various clinical database tools and applications for data collection, review, and the production of tables, listings, and graphs.
• Knowledge of data integration strategies and practices in support of external partnerships, strategic sourcing, and third party data acquisition.
• Skilled in project planning and management including resourcing, risk assessment, crisis management, and timeline projections.
• Strong negotiation and collaboration skills with ability to drive resolution of complex issues.
• Experience with Medidata Rave is a plus.

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.

Summary:

Data Acquisition and Standards, which is part of the Global Data Management and Clinical Monitoring organization, is accountable for the set up, validation and quality control of data gathered from external vendors during the conduct of Phase I-IV clinical trials.  This data must adhere to regulatory requirements and guidance.

Key Responsibilities and Major Duties:

• Management of study start up activities for clinical data from external sources.
• Drives (with the protocol team) the completion of the study start up activities related to data sourced by external vendors.
• Collaborates with the various functions to develop standards and ensure consistency and efficiency of the clinical protocols within an indication or program for study startup standards and documentation.
• Demonstrates ability to deal with difficult and unstructured assignments.
• Drives and owns the timelines, associated deliverables and serves as the External Data Subject Matter Expert at the study level.
• Drives the development of the database in collaboration with study build team and Global Biometric Sciences.
• Reviews the protocol to identify data collection needs. Remains critical to the protocol development and review process to ensure the most efficient data collection strategy is implemented. 
• Identifies any new external data types and develops them in conjunction with key stakeholders (e.g., Biomarker Leads, GBS, and Global Standards). 
• Reviews the specifications used to build the electronic Case Report Form (eCRF), visit schedule and derivations.
• Functions as the primary contact with external vendor staff for protocol level electronic data transfers. This includes preparing data transfer specifications from standard templates and ensuring vendor provides data compatible with the clinical database management system to allow for data integration. 
• Communicates and resolves external data set up issues with vendor staff and Clinical Team, as appropriate.
• Demonstrates a strong understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project.
• Proactively identifies and resolves issues noted during study startup and informs the appropriate team members and coordinates follow-up. 
• Engages the Data Management Lead and/or Protocol Manager to assist in the resolution of more complex issues.
• Understands how the issues of a single study can impact the overall project. 
• Manages matrix relationships to resolve operational issues at protocol level.

​Key Stakeholders/Contacts:

• Clinical teams, statisticians, scientists (Biomarkers, PK/PD,...), Central Clinical Laboratories and other 3rd party service providers.

Qualifications:

• One to four years of data management, programming or regulatory experience in a pharma research or central clinical lab organization.
• Bachelors Degree - B.S, Medical Laboratory Scientist (MLS), Medical Technologist (MT) or other scientific discipline preferred.
• Comprehensive understanding of clinical drug development process, including PK, PD and Laboratory testing terminology. Strong analytical skills to facilitate detecting and resolving data problems.

Global Quality & Regulatory Compliance, Clinical Trials & Safety

GQRC-CT&S is responsible for auditing all processed related to clinical research including specific medical affairs processes, and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator site, internal systems (e.g. REMS), and external vendor audits. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements.

Purpose/Objective of the job:

To conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits.

To act as project-specific liaison between GQRC-CT&S and key stakeholders, including Global Development Operations and Global Regulatory & Safety Sciences personnel, monitoring the status of the project(s) to plan audits and assuring GQRC-CT&S leadership is informed.

Key Responsibilities and Major Duties/

• Perform GCP audits of investigator sites, vendors and internal systems.
• Act as lead auditor, develop the audit plan and determine priorities for the audit. Prioritize and focus on matters of significance.
• Collect information through effective interviewing, listening, observing and reviewing documents, records and data.
• Maintain an in-depth knowledge of governmental regulations, which impact the research and development of medicines, as well as the most relevant Bristol-Myers Squibb Company policies, directives, and procedures related to clinical research.
• Manage health authority inspections and/or review of findings, and make recommendations for corrective and preventative action.
• Provide advice and counsel concerning GCP-related regulatory requirements.
• As appropriate, represent BMS within trade and professional associations.

  List of minimum requirements:

• University Graduate, Life Sciences degree preferred.
• Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication.
• Good understanding of the drug development process.
• Excellent oral and written communication.
• Fluent in English and other languages, as applicable to assigned audit region.
• Sense of diplomacy and discretion.
• Maintains the confidentiality and security of information, data, documents and records.
• Demonstrates commitment to delivering high-quality work product.
• Knowledge of relevant BMS policies and procedures as well as governmental regulations impacting clinical research and development.
• Strong critical thinking to analyse complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions.
• Software: Microsoft Suite, ESF, Jreview, PRISM, Trackwise CAT, Sharepoint, other systems as assigned/applicable.
• Approximately 25% travel to perform audits and attend professional meetings and seminars.
• Approximately 5 days per month overnight absences required.

The Protocol Manager is responsible to drive the successful and timely execution of global Phase I, II, III and IV clinical research protocols from study startup to final clinical study report within the established budget and timelines.

Serves as primary operational contact for the protocol. Coordinates the development of protocol level documents and plans, clinical supply oversight, vendor oversight, enrollment tracking, clinical data review and cleaning, coordination of audit responses, updating of various trial management systems, study close-out.

Demonstrates strong project management and organizational skills, monitors protocol progress and manages obstacles. Effectively leads a global team of individuals assigned to the protocol, demonstrating strong interpersonal and influencing skills, effective oral and written communication skills.

Knowledge Desired:

• Minimum education BA/BS. Scientific degree is highly preferred.
• Strong understanding of the pharmaceutical industry, and GCP, ICH and the regulatory guidelines as they apply to protocol management.
• At least 4 years of project management experience with at least 2 years in the pharmaceutical or healthcare industry.
• Demonstrates ability to drive clinical trial activities (experience in design, conduct and management of CTs: protocol and study report writing, monitoring, budgeting, regulatory obligations, AE reporting and managing CROs and external vendor
• Fluency in English is a must.

Experiences Desired:

• Excellent project and stakeholder management.
• Ability to multi-task and manage high performance demands.
• Experience in managing technology for information and communication tool (CTMS, IVRS, excel, Word, PowerPoint, etc.).
• Oncology experience is an asset.
• Strong communication skills.

BMS BioPharma Behaviors required

• Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
• Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
• Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
• Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.

Global Quality, Clinical Trials & Safety is responsible for auditing all processes related to clinical research and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator sites, internal systems and external vendor audits. GQ CT&S is also responsible for the management of regulatory agency inspections and for providing advice on regulatory requirements.

The candidate will be responsible for:
• Performing Pharmacovigilance audits, including audits of critical processes, affiliates, service providers/vendors and licensing partners to assess regulatory compliance, through:

- Applying audit principles, procedures, and methods to prioritize and focus on matters of significance;
- Collecting information through effective interviewing, listening, observing and reviewing documents, records and data;

- Evaluating independently and critically the quality management system and operations, balancing weaknesses against requirements and expectations;
- Confirming the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;
- Assessing those factors that may affect the reliability of the audit findings and conclusions;

- Performing and documenting analyses of audit findings where indicated:
- Preparing clearly-written, concise, accurate and evidence-based audit report;

- Maintaining the audit management database;
- Reviewing and assessing corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.

• Participating in the preparation, hosting and follow-up of regulatory authority inspections related to clinical safety and pharmacovigilance activities at central sites, affiliates and partners/vendors;

• Participating in due diligence activities and qualification audits of potential new vendors/partners;

• Maintaining an in-depth knowledge of Clinical Safety and PV system regulations as they apply throughout a product’s life-cycle;
• Providing advice and counsel concerning GVP regulatory requirements;
• Mentoring of new GQ-CT&S staff, as required.

Requirements:
• University graduate, Life Sciences degree preferred;
• In-depth knowledge of Clinical Safety and PV systems in the pharmaceutical industry and of applicable regulations. Able to apply theoretical knowledge in practical situation;

• Minimum of 4 years of experience in Pharmacovigilance gained from the pharmaceutical industry or equivalent;

• Minimum of 2 years technical PV auditing experience or equivalent;

• Demonstrates computer literacy and is able to function independently within an environment that relies heavily on technology for information and communication;
• Thorough understanding of the drug development and marketing processes;
• Excellent oral and written communication.

• Fluent in English, any other languages are a plus
• Sense of diplomacy and discretion;

• Maintains the confidentiality and security of information, data, documents and records;
• Demonstrates commitment to delivering a high-quality work product;
• Knowledge of relevant BMS policies and consequences of using sampling techniques for auditing;
• Strong critical thinking to analyse complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;
• Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective; Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;
• Develops strong working relationships with key stakeholders;
• Ability to manage competing priorities.

This position is the senior business partner to the assigned markets/clusters accountable for the strategic planning and delivery of IT digital capabilities.  This role will partner with the Head of the assigned markets/clusters as well as with the General Managers of singular markets and cluster markets to identify digital capabilities that have the greatest impact, identify simplification opportunities and jointly explore opportunities to foster innovation in the Commercial areas.  High impact digital capabilities will be supported by development of a comprehensive business case.  This role hires and manages IT for Commercial resources in market and provides support for other functions in the areas of interviewing and performance management.  This role will engage the appropriate IT matrix team to provide the technical expertise for solution delivery. 

Key responsibilities:

• Responsible for the strategic planning of digital capabilities for assigned markets/clusters.   The strategic planning will have a primary focus on commercial capabilities in support of sales, marketing and Access.   The strategic planning will have a secondary focus on the enablement and simplification of digital capabilities such as collaboration, workplace services and corporate functions.
• Responsible for the development of long-term (24-36 month) roadmaps identifying digital capabilities that have the greatest impact on the market.  Develops comprehensive business case(s) to support business outcomes of new/upgraded capabilities.   
• Responsible for developing strategic and collaborative partnerships with senior leaders in the assigned markets. Ability to become the trusted partner and advisor to all stakeholders in the assigned markets by demonstrating deep domain knowledge of the commercial business.
• Responsible for the communication, implementation and operation of the Digital Capability Governance process.  Demonstrate the ability to identify core enterprise digital capabilities and appropriately evaluate the value of potential differentiating capabilities when making platform choices.
• Responsible for the hire and management of IT for Commercial resources in market and provides support for other functions in the areas of interviewing and performance management
• Demonstrate matrix leadership of IT resources in other IT functions: responsible for ensuring that all IT functions are successful in their delivery of services to the assigned markets.  Key matrix IT partner functions include platform architecture, User Experience, software engineering, application support & maintenance,  program management, information & data management, collaboration services, infrastructure services.

Required:

• Ability to lead the strategic planning and implementation of digital capabilities for a commercial business unit (i.e. sales, marketing, access) in 1 or more market/clusters.
• Demonstrated ability to communicate, influence and partner with senior business leaders.
• Strong experience with governance operations and demonstrated ability to evaluate the need to respond to the customer in a timely fashion with the strategic investments being made at the enterprise level.
• Strong ability and comfort with matrix management in delivering digital capabilities.  Matrix management includes business partners as well as multiple IT capability leaders in diverse, geographically dispersed environments.
• Ability to manage business process analysis and improvement including benefit estimation and post implementation metrics.
• Ability to scan technical landscape for leading edge business solutions and creates business case for support and application, including level of effort/ cost required to implement solutions / services, and facilitating risk assessments.

Ideal Candidates Would Also Have: 

• Strong financial experience with budget management and business case development
• Multiple implementations of complex digital capabilities in pharmaceutical sales, marketing or access business units.

Other qualifications: 

• Master’s Degree and Years of Experience preferred (5-10 years)
• Strong business knowledge with proven leadership abilities and excellent executive presence
• Possesses familiarity with and awareness of the Pharmaceutical Industry
• Capable of working cooperatively across boundaries and within a matrix to achieve results.
• Ability to deliver complex systems to one or multiple geographies and business units.
• Experienced in information technology and management, project and portfolio assessment, planning, systems development and business case development
• Demonstrates strong influencing skills with key partners across the region.

This role reports to the Head, IT for Country, EMAC.

This role will prepare the individual with establishing consistent digital capabilities across multiple geographies in order to achieve a more senior level in the company.

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.

Purpose/Objective of the Job:

Provide senior-level operational oversight and leadership for the execution of Phase 1-Phase IV clinical program / clinical trials in the Oncology or Marketed Products Areas

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. 

Supervisory Responsibility- Provides Matrix Management oversight for Protocol Managers (PTMs) and Clinical Scientists (CS)

Key Stakeholders/Contacts – 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

List of minimum requirements:

• 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.
• 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.

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

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 months