The opportunity:- We are seeking an experienced Senior Director, Global Clinical Development Operations to provide leadership and strategic direction for the operational execution of Odyssey's clinical development programs. Reporting to the VP, Global Clinical Development Operations and working closely with the designated Program Leader and cross-functional leadership, you will ensure alignment and accountability for program execution and operate effectively within a matrix organization.
- This is a senior role responsible for establishing the clinical operations strategy for studies and ensuring the successful execution of complex clinical trials across the development portfolio. The Senior Director will provide operational leadership from study planning and start-up through database lock, clinical study report, and study closeout, while ensuring programs are delivered with the highest standards of quality, patient safety, data integrity, and operational rigor.
- The ideal candidate is a seasoned clinical operations leader with significant Phase 3 experience in the biotechnology industry, a strong track record of successfully leading global clinical trials, and the ability to operate strategically while remaining close enough to the work to drive execution. This individual will be a trusted partner to cross-functional senior leaders.
- The Senior Director will also play a critical role in evolving Odyssey's Clinical Operations organization and capabilities as the company advances its pipeline. This includes building scalable processes, developing talent, establishing effective partnerships with CROs and other external providers, and helping shape how Odyssey executes clinical development at scale.
Your primary objectives will be:- Provide strategic and operational leadership for Odyssey's clinical development programs, with particular accountability for the successful execution of Phase 3 clinical trials.
- Own clinical trial patient recruitment and enrollment strategy and performance, proactively identifying barriers to enrollment and mobilizing cross-functional teams, investigators, CROs, and other partners to resolve blockers and keep studies on track.
- Translate clinical development strategy into clear, executable operational plans, ensuring programs are delivered with the highest standards of quality, patient safety, data integrity, and operational rigor.
- Partner closely with Clinical Development and cross-functional leaders to shape study strategy, assess operational feasibility, anticipate risks, and identify opportunities to accelerate development.
- Provide strategic oversight of CROs, vendors, investigators, and other external partners, ensuring accountability for timelines, budgets, quality, and deliverables.
- Proactively identify and resolve complex operational challenges, providing clear recommendations and communicating program progress, risks, and resource needs to senior and executive leadership.
- Help build and evolve a high-performing, scalable Clinical Operations organization, including directly managing and developing talent, establishing effective processes and ways of working, and preparing the organization to support Odyssey's growing pipeline.
- Serve as a senior Clinical Operations leader and trusted partner to cross-functional collaborators.
- Contribute to broader clinical development and organizational strategy as Odyssey advances its pipeline and grows as a company.
About you:- Bachelor's degree in a scientific, medical, nursing, or other relevant discipline; advanced degree preferred.
- 12+ years of progressive clinical operations experience in the biotechnology or pharmaceutical industry.
- Significant, hands-on experience leading Phase 3 clinical trials, including demonstrated success taking studies through execution and key late-stage milestones.
- Demonstrated experience leading complex, global, multi-center clinical development programs.
- Proven ability to develop and execute clinical operations strategies at the program and/or portfolio level.
- Extensive experience overseeing CROs, vendors, consultants, investigators, and clinical sites.
- Strong knowledge and practical application of ICH/GCP guidelines and applicable clinical research regulations.
- Demonstrated experience managing clinical trial budgets, timelines, resources, risks, and operational performance.
- Proven ability to operate effectively in a fast-paced, evolving biotech environment with a high degree of autonomy and accountability.
- Demonstrated leadership experience, including the ability to develop talent, build teams, and influence across a matrix organization.
- Exceptional strategic thinking, judgment, problem-solving, and decision-making skills.
- Excellent written, verbal, and executive communication skills.
- Strong ability to influence and collaborate cross-functionally without relying solely on formal authority.
- Demonstrated commitment to patient safety, data quality, and operational excellence.
Preferred Qualifications:
- Experience leading clinical development programs in autoimmune and/or inflammatory diseases.
- Experience with small-molecule and/or protein therapeutic development.
- Experience supporting regulatory submissions and health authority interactions.
- Experience building Clinical Operations capabilities within a growing biotech organization.
- Experience establishing clinical operations processes, systems, governance models, and organizational infrastructure.
- Experience managing multiple programs or trials simultaneously within a growing portfolio.
The pay range for this role is:
176,554 - 220,692 USD per year (Boston, MA)
