Associate Director, Clinical Operations

Rapport Therapeutics • Boston, MA

2d • $185,000 - $205,000 • Hybrid

About The Position

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we’re driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we’re doing this with extraordinary science and awesome people (affectionately called Rapptors).
Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder.
The strength of Rapport comes from our Rapptors – who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you’re as excited about this opportunity as we are!
Your Impact:
The Associate Director, Clinical Operations will be responsible for leadership and oversight of all clinical trial activities including vendor oversight and management, from study start-up through execution and close out of all clinical trials supporting Clinical Development within the R&D organization.

Requirements

• 10-12+ years of Clinical Operations experience
• Experience in the Biotech or Pharma industry required
• Proven experience leading global Phase I-III clinical trials, with end-to-end ownership of study execution, timelines, and deliverables.
• Excellent knowledge and understanding of GCP/ICH and EU Guidelines for conducting clinical trials, and have inspection experience
• Excellent communication and organizational skills, with the ability to manage complexity across multiple regions and stakeholders.
• Demonstrated ownership and accountability, with a genuine care for the work and its impact

Nice To Haves

• NDA submission experience a plus

Responsibilities

• Ensure all trials are conducted according to relevant ICH/GCP guidelines and applicable local regulations.
• Responsible and accountable for planning and execution of clinical trials: oversight and directional alignment of timelines, budget, and key deliverables as well as contributing to overall clinical trial strategy.
• Establish and continuously monitor study timelines and budgets, promptly escalating significant risks or changes, as appropriate
• Provide input into and oversee development of clinical plans, detailed study plans and clinical documents (synopses, protocols, ICF’s, IB’s and CSR’s).
• Develop and manage study contracts, budgets and timelines
• Author/review core study documents including protocol and Informed Consent Forms
• Manage CRO, central lab, systems vendors, and ancillary vendors to ensure on target deliverables
• Lead internal cross-functional Clinical Study Team meetings and participate in external study related team meetings with vendors.
• Able to support regulatory strategy and assess trial/program impact from multiple countries
• May lead RFP process, budget development, and study forecast/planning including timelines
• Manages oversight of clinical monitoring activities including monitoring trip report review and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
• Manage team with direct reports within therapeutic area
• Clinical Operations lead on cross functional project teams and alliance teams
• Stakeholder management with internal business partners, key opinion leaders, and external partners on clinical studies
• Oversee clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.

Benefits

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed