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 clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role:

As a major contributor to the successful execution of compassionate use protocols, an expanded access program and other clinical trials, perform a key role in building and maintaining relationships with Investigators and other study site personnel, internal team members, and CRAs and CRO team members, as needed. Based on a thorough understanding of the mechanics of conducting clinical trials internationally, closely supervise all aspects of Clinical Trial Operations, including clinical project management, oversight of study center activities, CTA/CRA monitoring activities and vendor management.

Key Responsibilities:

• Oversee CRO study team(s), clinical sites and vendor(s) on assigned studies to ensure consistency of methods, interpretation and approach with compassionate use, expanded access and other Syndax sponsored studies.
• Develop or review compassionate use and expanded access protocols, information/consent forms, study training materials, case report forms and study tools for assigned study.
• Conduct training for logistics of the clinical trial including protocol contents and coordinating trial materials.
• Oversee monitoring activities and conduct clinical site initiation visits, co-monitoring and close-out visits, as needed.
• Manage study timeline and provide study progress reports to management.
• Plan and provide solution options for handling problems that develop.
• Maintain tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and data cleaning information, etc.)
• Ensure that all tasks that contribute to the conduct of a clinical study are completed according to GCPs and SOPs, as well as on time and within budget.

Desired Experience/Education and Personal Attributes:

• Bachelors' Degree in life sciences or healthcare discipline; Master's Degree preferred.
• At least 5 years of clinical trial management experience in the biotech/pharmaceutical industry; experience in supervising people.
• Oncology trials experience is required.
• Experience with operational execution of studies such as Expanded Access Programs within Medical Affairs preferred.
• Working knowledge of GCPs and FDA and ICH regulations and guidelines.
• Experience with international clinical trials and managing external service providers including CROs Good understanding of cross functional areas including data management / biostatistics, regulatory affairs and pharmacovigilance.
• Proven verbal and written communication skills; enjoys interacting with others regularly.
• Able to prioritize tasks and work independently.
• Able to travel an average of 15%, both domestically and internationally.

Location: Syndax has offices in Waltham, MA and New York City and has a dispersed workforce across the United States.

Periodic travel may be required for this role. To help ensure the safety and well-being of our employees, visitors, and other stakeholders, Syndax strongly encourages employees/consultants to get vaccinated/boosted against COVID-19 prior to participating in an in-person meeting or traveling on behalf of Syndax.

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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