Vice President, Clinical Development 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 Vice President, Clinical Development Operations is a key leadership role responsible for driving the strategic vision and operational execution of clinical trials across all phases of development. This individual will oversee the clinical operations function, leading and developing a multidisciplinary team to deliver high-quality, on-time, and on-budget clinical trials while ensuring the highest standards of compliance and ethical conduct. Reporting to the Chief Medical Officer, this leader will play a critical role in shaping the direction of clinical development at Atalanta Therapeutics, collaborating closely with senior leadership, cross-functional teams, and external partners to achieve clinical milestones and drive the company’s programs forward.  

RESPONSIBILITIES:

• Develop and implement the clinical operations strategy, ensuring operational efficiency, consistency, and quality across all clinical trials
• Manage and oversee the planning, initiation, execution, and monitoring of clinical trial processes
• Provide leadership, strategic oversight, and guidance of Clinical Operations (including CROs) to ensure quality, timeline, resources, and budget goals are met
• Establish clear goals, objectives, and key performance indicators (KPIs) for the team to ensure successful execution of clinical trials
• Provide key input into all clinical development activities including integrated development plans and study protocols
• Act as the voice of clinical operations and provide regular updates on clinical program progress to the leadership team, project teams, board of directors and other key internal and external stakeholders
• Build, mentor, and lead a high-performing, cross-functional clinical development team, holding individuals accountable for results while providing internal training and professional development opportunities
• Champion a culture of continuous improvement and professional growth, ensuring that team members are equipped with the appropriate skills and knowledge to succeed
• Oversee, plan, and implement Quality Checks to ensure high standards for compliance with company SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards
• Accountable for authorship of operational sections of protocols and investigator brochures, and leading the identification of and interaction with investigative sites, investigators, and site staff
• Lead the selection, negotiation, and management of clinical vendors to ensure alignment with company goals and compliance with contractual obligations
• Build and nurture strong 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)
• Oversee the preparation for audits, inspections, and regulatory submissions, ensuring that clinical data and documentation are complete and accurate
• Manage submissions to ethics committees and ensure that all clinical trials comply with regulatory requirements, ethical standards, and company policies, including ICH-GCP guidelines, FDA, EMA, and other applicable regulatory bodies
• Foster a culture of innovation within the clinical operations team, encouraging new approaches to trial design, data collection, and patient engagement while driving the adoption of new technologies and resources to improve trial efficiency

QUALIFICATIONS:

• A minimum of a Bachelor’s Degree is required; An advanced degree (e.g. MS, PhD, PharmD) is a plus
• A minimum of 15 years of industry experience in clinical operations development in roles of increasing responsibility
• Experience leading cross-functional teams across multiple therapeutic areas, preferably in CNS, rare disease, or related field
• Experience across clinical operations value chain, with a track record of success in resource planning, study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
• Expertise in vendor and CRO management, budget oversight, risk management, and regulatory compliance
• Expert understanding of Good Clinical Practices (GCP), ICH Guidelines and FDA/EMA regulations
• Experience with global drug development and IND/CTA filing is preferred; experience in developing protocols, SOPs, CSRs, INDs, NDAs as well as other clinical, regulatory and safety documents preferred
• Strong leadership, strategic thinking, and decision-making capabilities
• Demonstrated ability to build, coach, motivate and supervise a high-performing team
• Excellent communication skills with the ability to influence and collaborate at all levels of the organization
• Able to adapt management style to many different situations and give guidance to others in appropriate style development
• Possess excellent written and verbal communication skills, including being able to present information and lead effective meetings
• Proven ability to manage complex projects and solve problems in a fast-paced, dynamic, and ever-evolving environment
• Deep understanding of clinical trial design, regulatory requirements, and industry best practices
• 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.