Director Clinical Trial Strategy amp Operations

Profile

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.

Summary/Scope

Provides strategic oversight and operational leadership for one or multiple programs with a focus on the development and maintenance of accurate program operational plans including timelines and budgets.

Represents GCO on the Global Project Team.

Proactively contributes to strategy development, identifies and supports resolution of issues, and helps facilitate alignment within GCO, other functions within BMS, and with external partners.

Manages and develops direct reports.

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

Program Oversight

Oversees strategic planning and execution of clinical programs to ensure timely and high-quality project deliverables; other responsibilities include:

Overall strategic management for the planning, execution and reporting of large, complex and/or multiple clinical programs, within the assigned portfolio, needed to support INDs, sNDAs, NDAs, MAAs and phase 3b/4 studies supporting life cycle management with a focus on cost disciplined science.

Interacts with trial leads to ensure consistent performance and quality of work.

Works cross functionally as required to support appropriate resourcing of study teams.

Strategically assesses and evaluates program needs and supports implementation of appropriate plans for action.

Participates in the program/portfolio reviews with CRO partners.

Interacts with other departments as well as cross-functional teams (i.e. Clinical Development Teams, Project Teams); other responsibilities include:

Represents GCO on assigned project teams and actively shapes the clinical development and operational strategy/tactics.

Integrates appropriate input arising from internal and external team members into the clinical operation strategy.

Identifies and recommends solutions to problems and/or issues with personnel and/or processes across departments.

Functions as the go to operational leader and the primary escalation point for study/development team and is viewed as operational leader” by governance and senior stakeholders on the program.

Study Input/Guidance:

Provides indication specific and operational input to shape study protocols and clinical development plans.

Provides strategic consulting in relation to the portfolio/franchise.

Evaluates clinical data trends and supports team as needed to mitigate risks.

Participates in vendor selection and review process.

Provides guidance and development to the GCO study team members globally in the assigned portfolio/franchise.

Budget & Resourcing

Drives the early planning of timelines and budgets through close collaboration with trial leads and other collaborating functions.

Collaborates closely with Project Leadership to ensure that timelines and budgets are appropriately presented to governance committees.

Supports identification and resolution of issues related to study timelines and budgets.

Leads regular (e.g. quarterly) program budget review meetings with Finance and ensures that anticipated budget deviations are flagged.

Reviews planning and tracking tools regularly (including study budgets), flags deviations to relevant stakeholders and develops mitigation plans in collaboration with Clinical Trial Managers and other relevant functions.

Notifies GCO Leadership (and other relevant functions) of resource requirements for existing and new studies.

Considers the broader needs within the portfolio/franchise and GCO as a whole when making resource requests and decisions on the program level.

Talent Development/Management

Provides oversight to direct reports to ensure clinical trial management in accordance with functional guidelines/processes, ICH/GCP, as well as applicable regulations/guidelines and SOPs/WPs to support compliance, quality, efficiency and successful completion of operational activities related to key milestones.

Builds the functional expertise of the department and ensures that adequate program-specific and role-specific training is provided.

Develops, coaches, motivates, and empowers direct reports to have a high degree of accountability for performance and oversees key deliverables.

Engages and energizes employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements.

Facilitates functional talent development, succession planning and performance management processes to ensure that individuals are held to appropriate, consistent standards and that key leadership development and succession plans are established.

Serves as resource/mentor on operational issues, company policies and procedures as appropriate.

Develops and promotes strong collaborative relationships with globally dispersed colleagues within and outside BMS demonstrating teamwork and leadership skills.

Supports recruiting of staff by reviewing CVs, assessing candidates, performing interviews, making hiring recommendations, overseeing training and documentation of requirements.

Continuous Improvement

Leads and/or actively contributes to continuous improvement initiatives within and outside GCO.

Works with GCO and external colleagues to maximize efficiencies, share and apply best practices.

Identifies new process opportunities, drives and supports process improvement initiatives and works with appropriate personnel to implement and re-evaluate processes.

Experience in leading/directing change management in a dynamic environment.

Skills/Knowledge Required

Experienced clinical R&D professional with knowledge of industry trends and experience in leading and driving operational programs and initiatives.

Cell therapy and disease/therapeutic knowledge and expertise highly desirable.

Excellent financial forecasting, budgeting, and resourcing skills.

In depth knowledge of ICH/GCP, regulatory guidelines/directives and drug development process.

Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical trials/development with other functions (e.g. nonclinical & pharmaceutical development, regulatory, commercial/marketing).

Proven problem-solving skills to prevent and overcome complex safety and compliance related

issues during clinical program implementation and execution.

Highly proactive risk identification, contingency planning, and innovative problem solving.

Ability to lead and drive program planning and delivery in collaboration with CRO partners.

Experience in leading/directing change management in a dynamic environment.

Key Leadership Competencies

Strong organizational savvy to manage senior level stakeholders.

Translates the organization's vision and strategies into meaningful plans for the function, connecting them to the mission of each department/team.

Maintains focus on strategic objectives while accomplishing operational goals.

Demonstrates ability to build and maintain a high-performance clinical research organization/team.

Makes sound decisions that align with BMS's goals and strategy.

Ensures that conflict is handled constructively so that performance is not impacted.

Displays a willingness to challenge the status quo and take risks.

Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.

Promotes the sharing of information across departments and/or teams within the function.

Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies.

Demonstrates understanding of the external environment and its implications for both BMS's and the function's goals and strategies.

Deals constructively with own failures and mistakes, and adapts behavior based on feedback and experience.

Demonstrates effectiveness as a mentor, coach, and leader.

Speaks clearly and concisely, encourages others to express their views (even contrary ones), and listens attentively and with empathy to concerns expressed by others.

Exemplary leadership/influence management skills with ability to foster partnerships in the matrix organization across functional/geographies/cultural/partner boundaries.

Anticipates future needs within the function when selecting and developing talent (e.g., develops successors and talent pools for key positions).

Leads an organization or team in meeting multiple conflicting priorities and making difficult resource allocation decisions (financial and people).

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 is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com