Associate Project Director (APD)

Description

Associate Project Director (APD)

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
. We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program.
. We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Essential Duties and Responsibilities

• Serve as Country Study Manager for CART clinical trials in Taiwan, overseeing endtoend countrylevel study execution.
• Manage and coordinate CROs and vendors, ensuring delivery of study milestones in alignment with global study timelines and expectations.
• Partner closely with the global study team to proactively identify, escalate, and resolve country and sitespecific operational challenges.
• Establish and maintain strong, collaborative relationships with key institutions and Key Opinion Leaders (KOLs) in Taiwan.
• Conduct site oversight and relationshipbuilding visits as required to support study conduct and performance.
• Provide local expertise and input into the review of regulatory and ethics committee submission documents, site contracts and budgets, Trial Master Files (TMF), Investigator Site Files (ISF), and study plans.
• Serve as the subject matter expert on Taiwanspecific cell therapy regulations, including site capabilities, experience, and suitability for CART development studies.
• Contribute to study budget planning and ensure effective and timely site budget and contract negotiation processes within the region.
• Lead and/or support local regulatory inspections and audits as required, in collaboration with global and local stakeholders.

Knowledge, Experience, and Skills

• Master's degree in a relevant scientific or life sciences discipline.
• Prior experience working within the pharmaceutical or clinical research industry is preferred.
• Minimum of 4+ years of solid project management experience in the clinical trial industry.
• Demonstrated project management experience in Hematology and Oncology clinical studies CART or cell therapy experience is strongly preferred.
• Thorough understanding of clinical trial regulations, ethics committee submissions, site contract and budget processes, ICH Guidelines, and GCP governing the conduct of clinical studies.
• Strong communication and stakeholdermanagement skills, with the ability to effectively engage investigators, site staff, CROs, and internal crossfunctional teams to deliver study milestones.
• Proven ability to work collaboratively in a matrix environment, with excellent organizational, decisionmaking, and problemsolving skills.
• Fluency in both English and Mandarin (written and spoken) is required.
• Willingness and ability to support domestic and international travel as required.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. 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.

Summary

This role is responsible for the local execution of CAR T clinical trials in Taiwan, working in close partnership with the global Clinical Operations team and cross functional stakeholders in country. The role serves as the primary country study manager, ensuring high quality study execution in compliance with global and local regulatory requirements.