Assoc Dir, Clin Trial Supplies

Based, US Home
08 May 2021
06 Jun 2021
Full Time
Experienced (non-manager)
Associate Director, Clinical Trial Supplies

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities
Clinical Trial Supply Management Leadership and Delivery:
• Manages a project as a Clinical Trial Supply Manager overseeing interdisciplinary clinical research study product supply chain duties and/or programs and ensures compliance with GMP, GCP, relevant SOP's and regulatory requirements.
• Acts as primary liaison and/or facilitator between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
• Leads project team to ensure quality, timelines and budget management.
• Implements resource strategies to achieve project goals.
• Accountable for all project deliverables for assigned projects.
• Develops contingency planning and risk mitigation strategies to ensure successful delivery of study product supply goals.
• Identifies and implements performance improvement and operational efficiencies.

Reporting and Communication:
• Maintains and evaluates project progress by maintaining timelines, project plans and other tracking/analysis tools.
• Produces and distributes status, resourcing, and tracking reports as well as functional area plan to customers, appropriate team members and senior management.
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports; ensures adequate documentation of each communication.
• Attends and presents information at internal and external project meetings.

Business Development:
• Develops strong relationships with current and prospective clients to generate new and/or add-on business for the future.
• Supports the Business Development Department by providing information on Company's capabilities, patient populations, etc. and presents Company capabilities as well as clinical trial supply management (CTSM) specific responsibilities at Customer proposal defence meetings.
• Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities. Works with this team to develop budgets and scope of work for the final contract.

CTSM Administration:
• Responsible for quality and completeness of the TMF for assigned CTSM projects.
• Accountable for the financial performance of each CTSM assignment.
• Accountable for all project deliverables for each CTSM assigned.
• Accountable for maintenance of CTSM information on a variety of databases and systems.
• Responsible for study CTSM components of inspection readiness for all aspects of the study conduct.
• Works with other stakeholders to ensure SOPs, WIs and related tools are appropriate and consistent with the Syneos Health work processes. Works with the SOP liaison to update documents as needed.

CTSM Mastery:
• Demonstrates mastery of current clinical supply and vendor deliverables and facilitates the development of knowledge for more junior staff.
• Facilitates team training in accordance with protocol and/or project requirements including therapeutic, protocol specific, and process training.

CTSM Management:
• Serves as team leader and line manages and mentors other a Clinical Trial Supply Managers and assistant staff.
• Facilitates team building and communication.
• Ability to successfully deliver a project through successful delegation and oversight of project and functional leads.What we're looking for
• Pharmacy degree or Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent.
• Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company in Clinical Trial Supply Management and in leadership roles.
• Strong knowledge of Good Clinical Practice/ICH guidelines/Good Manufacturing Practices and other applicable regulatory requirements
• Strong organizational and leadership skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade
• Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
• Ability to travel as necessary (up to 30%)

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.