Job Description Summary

The Director, Global Clinical Affairs, (a key leadership role within Global Clinical Affairs (GCA)) supports IDS BU for COVID; Molecular and Immunology Point of Care, and corporate objectives by directing the daily activities of Clinical Affairs personnel to successfully deliver high quality Evidence, generated on time and within budget. The ideal candidate will demonstrate a proven ability to independently facilitate and lead a highly functioning result-oriented team by providing direction, oversight and developmental support to department personnel. The ideal candidate will also demonstrate proficiency and effectiveness in scientific and operational matters related to clinical program development, as well as clinical study strategy, implementation, and execution.

Job Description

Job Description

This function provides the critical connection between the IDS Business Unit and regionally based Medical Affairs (MA) teams and GCA. This role will sit on the MA Leadership team within the BU/Region to ensure strategic alignment between the BUs, Regional MA, and GCA on Evidence Generation and Dissemination Strategy.

The Director, works extensively with other GCA functional groups, including Statistics, Data Management and Clinical Quality, and interfaces with other groups such as HEOR, R&D, Scientific Affairs, Quality, and Regulatory Affairs to translate needs into evidence generation requirements and assists with determination of execution responsibilities and integration of these study needs into the overall GCA portfolio. 

Primary Responsibilities

• Plan and strategize with the internal Business Unit management cross functional teams (R&D, Marketing, Quality, and other business partners) to define, implement, and execute global clinical strategies in support of business objectives
• Plan and coordinate departmental and project resources, timeline and budgets
• Effectively communicate with Business Unit and Medical Affairs Management teams
• Lead and guide Clinical Program Managers and Clinical Affairs professionals
• Oversee the development and management of evidence generation and dissemination, budgets, contracts and required resources
• Oversee clinical programs for compliance with protocols, corporate standards and procedures, regulations and Good Clinical Practice guidelines
• Oversee compliance in reporting (clinical study reports, notified bodies, ct.gov)
• Serve as Subject Matter Expert on initiatives in support of executive leadership team initiatives
• Provide Subject Matter Expertise during due diligence reviews for business development (M&A) activities
• Understands BD culture and values and reflects them in his/her own behavior
• Evaluates and monitors external and internal trends and business needs as they pertain to GCA activities.
• Drives innovation and continuous improvement for the GCA by evaluating and monitoring external trends in best practices for evidence generation and dissemination, and regulatory requirements worldwide to identify relevancies to BD. 
• Serves as a representative to other key BD initiatives and is a liaison with other BD activities in the area of portfolio management and resource management with other functions or external organizations
• May perform other duties as required

Education

• Bachelor degree required, with advanced degree preferred (e.g., MS, MPH, MBA, PhD, PharmD, MD). 
• Minimum 12 years of relevant experience in pharmaceutical or medical device clinical development, including  experience in managing large, complex projects and successfully establishing and implementing near- to medium-term functional strategies across medium to large sized organizations
• Minimum 10 years of experience mentoring, leading, and developing individuals and organizations and managing resources across multiple competing projects.
• Demonstrated excellence in resource management within complex portfolio development
• Strong knowledge of study design, FDA medical device regulations, Federal and State law governing clinical research including human subject protection and HIPAA, and experience with IDE and/or NDA Trials. Certification of Good Clinical Practice (GCP) is required.
• Demonstrated ability to establish and lead a successful global functional unit. 
• Demonstrated ability to establish and build successful collaborations/liaisons with internal peers and senior management across multiple disciplines, businesses, regions and organization level. 
• Demonstrated ability to work well independently as well as a member of multiple, integrated teams
• Strong project planning, project management, leadership, negotiation, writing and presentation skills as well as an ability to contribute creative yet practical solutions to problems
• Ability to manage several projects in parallel, with appropriate attention to detail. A wide degree of creativity and latitude is expected.  Ability to make decisions with limited data and work effectively in a rapidly changing and ambiguous environment.
• Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of work and resolve the issues in a timely fashion
• Outstanding communication skills, oral and written required
• Travel is estimated to be < 30%, US and internationally

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift