Associate Director/Director, Clinical Operations

Building on our founders’ Nobel-prize winning discoveries in RNA interference, Atalanta Therapeutics is developing novel Di-siRNA therapies to treat severe neurological diseases at the root cause. With a robust internal pipeline along with key strategic partnerships in place, Atalanta is poised to make a meaningful difference in people’s lives. We are driven by a culture of integrity, respect, collaboration, and continuous learning. We are located in Boston’s vibrant Seaport district near South Station.

POSITION SUMMARY:

The Associate Director/Director, Clinical Operations plays a pivotal role in overseeing the successful execution of clinical trials, ensuring their alignment with Atalanta’s goals and strategic objectives. This individual will focus on operational oversight across all phases of development, ensuring adherence to timelines, budgets, regulatory standards, and quality control.  Reporting to the Senior Director, Clinical Development Operations, this individual will play a critical role in shaping the clinical operations function, representing clinical operations in discussions at all levels of the organization and collaborating with cross-functional teams as well as external partners to achieve clinical milestones and drive the company’s programs forward.  

RESPONSIBILITIES:

• Manage and oversee day-to-day clinical trial operations, ensuring adherence to GCP guidelines, company SOPs, regulatory requirements, and patient safety standards
• Monitor trial progress, identify risks and issues, and work with teams to implement corrective actions or preventive measures to mitigate risk
• Contribute to the planning, initiation, execution, and monitoring of clinical trial processes
• Ensure the successful execution of clinical trials, including subject recruitment, investigator selection, site management, and data collection
• Provide key input on trial budgeting, resource allocation, and timelines, ensuring all trials remain within scope and budget
• Collaborate with key stakeholders, both internally and externally, to ensure alignment and communication on clinical trial milestones, updates, and deliverables
• Engage with external vendors and partners to ensure clinical trial services are delivered in accordance with established agreements and regulatory requirements
• Contribute to the strategic planning of clinical development programs and provide input on trial design and operational improvement strategies
• Assist in the preparation of clinical trial and study reports, meeting agendas, and presentations for senior leadership
• Nurture and maintain strong working relationships with CROs, external experts, and investigators, ensuring that external partners deliver high-quality services in a timely and cost-effective manner
• Partner with biometrics staff to deliver high quality data deliverables on time and on budget (including but not limited to the development of case report forms, collaborations with statisticians, data managers, data review, clinical study reports)
• Contribute to the preparation and execution of successful audits, inspections, and regulatory submissions, ensuring that clinical data and documentation are complete and accurate
• Foster an environment of continuous improvement and actively participate in the recruitment, training, and professional development of clinical operations team members

QUALIFICATIONS:

• A minimum of a Bachelor’s Degree is required; An advanced degree (e.g. MS, PhD, PharmD) is a plus
• A minimum of 8-10 years of industry experience in clinical operations in roles of increasing responsibility
• Experience working independently as well as in cross-functional teams across multiple therapeutic areas, preferably in CNS, rare disease, or related field
• Proven track record in the successful delivery of clinical trials in compliance with regulatory and operations standards
• Demonstrated experience in vendor and CRO management, budget oversight, risk management, and regulatory compliance
• In-depth understanding of Good Clinical Practices (GCP), ICH Guidelines and FDA/EMA regulations
• Experience with IND/CTA filing is preferred; experience in developing protocols, SOPs, CSRs, INDs, NDAs as well as other clinical, regulatory and safety documents is preferred
• Ability to navigate complex project management tasks and prioritize multiple competing priorities in a fast-paced environment is essential
• Excellent written and verbal communication skills with the ability to collaborate at all levels of the organization
• Strong problem-solving abilities and high attention to detail is essential
• Willing and able to travel domestically and internationally up to 20%

Atalanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.