Associate Director, Clinical Operations

Syndax Pharmaceuticals is looking for an Associate Director, Clinical Operations

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role: 

The Associate Director, Clinical Operations will effectively manage the day-to-day operations of several phases of drug development and/or multiple high complexity projects.  They will demonstrate a deep understanding of the pharmaceutical industry trends and challenges, and the competitive environment for the projects/programs proactively translating them into specific steps at the functional level as applicable.  The Associate Director performs a key role in building and maintaining relationships with Investigators and other study site personnel, CRAs and CRO team members.  Based on a thorough understanding of the mechanics of conducting clinical trials, closely supervise all aspects of Clinical Trial Operations, including clinical project management, oversight of study center activities, CRA monitoring activities and vendor management. 

Key Responsibilities:

• Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our CROs and other vendors, including escalation of issues to governance committees and to senior management when warranted
• Directly oversee contract CRAs, CRO study team(s), clinical sites and vendor(s) on assigned studies to ensure consistency of methods, interpretation and approach with other Syndax sponsored studies to include (but not limited to)
  • Site feasibility
  • Study strategy
  • Site selection
  • Enrollment planning and mitigations
  • Data Review
  • Assessment of Protocol Deviations
• Develops risk management and remediation plans that are guided by organizational as well as project strategies and objectives
• Ensure study oversight by developing and managing to study timelines and providing updates on KPIs, metrics, study progress and risk to senior management monthly at a minimum
• Assist in the development and review of protocols, investigator brochures, clinical study reports and other clinical documents and regulatory filings as needed
• Collaborate with Clinical Supply Management to provide supply forecasting for assigned studies
• Develop information/consent forms, study training materials, study management plans, and study tools for assigned study
• Participate in review of case report forms, CRF completion guidelines, edit checks, and perform UAT if applicable
• Support financial management of study to include vendor contract review, invoice approval, change order review, and monthly meetings with finance to ensure study maintained within budget
• Conduct both operational and study content training for CRAs, CRO study teams, study site staff (as needed) and internal study team members, ensuring all team members are appropriately trained throughout the course of the study
• Actively develops and implements changes to improve quality within the functional area
• Support processes related to inspection readiness and coach study teams to work with a spirit of high quality and inspection readiness
• Oversee to ensure that paper and electronic filing systems are maintained appropriately and in a timely manner
• Oversee tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and data cleaning information, etc.)
• Supervises and/or mentors others within the function
• May serve as Clinical Operations expert in support of other clinical operations colleagues lending expertise and guidance
• Ensure that all tasks that contribute to the conduct of a clinical study are completed according to GCP and SOPs

Desired Experience/Education and Personal Attributes: 

• Bachelors’ Degree in life sciences or healthcare discipline; Master’s Degree preferred
• At least 7 years of clinical trial management experience and at least 2 years of clinical monitoring experience, in the biotech/pharmaceutical industry
• Working knowledge of GCP and FDA and ICH regulations and guidelines
• Experience with international clinical trials and managing external service providers, CROs and contract CRAs
• Strong understanding of cross functional areas including data management / biostatistics, regulatory affairs and pharmacovigilance
• Experience supervising and/or mentoring people
• Effective verbal and written communication skills; enjoys interacting with others regularly
• Able to prioritize tasks and work independently
• Able to travel an average of 20%, both domestically and internationally

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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