Sanofi Group Associate Director, Clinical Project Leader Management in Bridgewater, New Jersey
In the role of Associate Director, Clinical Project Leader (CPL) Management you will be heading the operational efforts within the North American Clinical Study Unit (NA CSU) for studies in a given therapeutic area(s). The Associate Director, CPL Management will have direct line management responsibility for CPLs and for ensuring the training, coaching, motivation and development of individuals allocated to his/her group to maximize their capabilities, performance, and overall utility. This position will support in the coordination and delivery of study activities. The Associate Director, CPL Management will also give centralized operational support to the clinical team (in house and regional team). The Associate Director, CPL Management will be responsible for resource management within their group and will communicate study updates, timelines, and action items with the NA CSU Head of Project Management and appropriate stakeholders. This position shares CSO accountability for the regional execution of clinical programs in his/her group in agreement with the country/region defined commitments, timelines, quality requirements, and allocated budget.
The Associate Director, CPL Management will have oversight responsibility of project management, project assignment and operational/procedural/administrative role. The Associate Director, CPL Management will act as a key operational interface with internal and external services to develop, implement, maintain and improve operational processes for NA clinical trial conduct. The Associate Director, CPL Management will act as a key interface with Project Leaders and other NA CSU management (e.g., Regional Operations and Quality, Systems & Training, Safety and Study Start-Up) leads to implement processes and system improvements.
Major Duties & Responsibilities
Direct/lead team that is conducting Phase I-IV clinical trials in a timely, ethical and scientifically responsible fashion. Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned studies. Responsible for the direct management of the CPLs to ensure execution and compliance with the designated duties as per the NA CSU Project Management Head. Ensure that all activities under his/her direction comply with sanofi Research & Development SOPs, NA CSU/US CSU SOPs, GCPs and country specific regulations.
Conducts objective setting and ensures that individuals have well-defined attainable, and measurable objectives aligned with those of the Company, Project Team, CSU, and personal developmental needs and aspirations. Conducts high quality performance appraisals with ongoing performance feedback and coaching. Ensures written performance appraisals and developmental activity plans are adequate to facilitate effective individual development, talent management, succession planning and identification of training needs.
Key operational interface with internal and external servies to develop, implement, maintain and improve operational processes for NA CSU clinical study conduct and enrollment. Ensures communication pathway, promotes productivity and performance. Collaborates with other CROMs to identify best standards and efficiencies for trial conduct across the NA CSU.
Interface with the CSO Project Leaders, CTOMs, CSDs, and Project Heads to understand portfolio and project needs and ensure optimal flow of information relative to study status, challenges, risks, etc
Ensures study delivery per CSU commitments. Ensures effective communication and mitigation of study risks/challenges and seeks input/assistance from relevant stakeholders when appropriate. Assists individuals in problem solving and corrective measures while encouraging resolution at lowest empowered level and escalating when appropriate.
Responsible for regular assessment and management of resource needs for his/her group. Initiates recruitment and selection of all new hires.
Ensure audit report findings are consolidated & communicated as lessons learned. Fosters NA CSU operational improvements as warranted.
Drives change and implementation of new approaches and standards within his/her group. Ensures consistent, timely and appropriate circulation of updated information and adequate reporting of implemented actions internally and externally as required or requested. Participates in the development of local/global SOPs, policies, guidelines or related tools via participation in working groups and collaboration across CSU and CSO.
Bachelor's degree in a Science/Medical or related field and 10+ years of pharmaceutical industry experience including 3+ years experience in the direct management of people required.
5+ years of clinical trial experience/clinical trial management experience & 3 years of previous field monitoring experience required.
Alternatively, demonstrated comparable or equivalent experience experience will be considered.
Demonstrated ability to effectively lead by influence and operate as a role model of company values.
Advanced knowledge of drug development, therapeutic area disease states, clinical study execution, project management, principles, FDA regulations and ICH /GCP guidelines. Respect for Quality and Compliance in all aspects of clinical trial conduct.
Experience in identification, development, design and implementation of operational procedures, budgeting and resource management.
Strong leadership, mentorship, organizational and time management skills required.
Excellent analytical, interpersonal and communication skills (verbal and written) essential.
Ability to provide internal/external operational expertise for a given therapeutic area.
Demonstrated supervisory and managerial skills, including ability to influence and motivate people.
Demonstrated ability to give developmental feedback on performance assessments.
Solutions oriented business acumen important, along with critical decision making and self-motivation qualities.
Cross functional operations understanding is essential.
Advanced degree in a Science/Medical or related field
Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life