Clinical Operations Development Lead
Odyssey Therapeutics is propelling drug development beyond what is now possible to deliver medicines that address critical needs of patients with inflammatory diseases and cancer. We achieve unprecedented speed and efficiency by bringing together a target-centric approach, a toolbox of cutting-edge technologies, and a team of accomplished, world-class drug hunters. By reimagining the drug development process, we are creating a deep and broad drug pipeline that holds the potential to transform human health.
Job Title: Clinical Development Operations Leader
Location: Boston, MA
Employment Type: Full-Time, onsite/hybrid/remote
Department: Target Biology
We are seeking a highly motivated Clinical Development Operations Leader to join the Odyssey. You will support operations of regional and global trials with minimal supervision in a small fast-paced company environment. You are a seasoned clinical operations leader who is comfortable working independently and experienced managing cross-functional activities internally and externally. As an integral senior member of the Odyssey Clinical and Translational Development team, you possess strong skills for internal leadership and coordination as well as external vendor management with deep experience in selection and management of full-service CROs and other contracted partners. You are a proactive problem-solver with proficient verbal and written communication skills.
You will work in a highly cross-disciplinary, fast-moving, and fluid environment, and will be drawing upon extensive experience driving drug discovery projects. You will possess strong interpersonal and leadership skills, be a world-class thought partner, and have a proven record of developing science.
As a critical member of the Odyssey team, you will be a key voice in the evolution of Odyssey’s science and platforms, offering opportunity for growth and impact. Odyssey prides itself as an exceptionally talented team with a broad range of skill bases. Together with your colleagues, you will help shape the Odyssey culture, strategic direction, and outcomes.
- Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
- Build and lead Odyssey Clinical Operation capabilities including infrastructure, and processes (e.g., SOP development and review, financial tracking for assigned project(s), management of clinical systems, oversight of clinical metrics tracking and reporting)
- Advises on strategic input on clinical operations pipeline and goals, including input in the overall clinical development plan on an enterprise scale
- Develop clinical trial budgets, and provide oversight of timeline and resource requirements and provides input to the financial plan (created and maintained by the PM working with the Finance business partner)
- Reviews the program dashboards and provides input to the PM to ensure accurate status updates on key milestones achieved, issues/risks and financial status
- Ensures audit/inspection readiness of the assigned program/trials. Support audits and inspections
- Reviews and provides input to the overarching clinical program and documents such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA and other regulatory critical documents.
- Ensures timely responses to clinical site staff and all regulatory agencies
- Accountable for external vendor selection and management, and assists in the development of RFPs and vendor oversight plans
- Provide clinical leadership to CROs, other vendors, and cross-functional study team
- Independently or with CRO partner facilitate site contracting process, including helping with negotiations and managing site budgets
- Develop and implement robust risk identification and mitigation plans to solve complex issues that impact study or program milestones
- Develops strong, collaborative working relationships with CROs/vendors, key investigators, and other key staff/vendors
- Collaborates with team, CRO to identify appropriate study investigators and sites
- Partners with team, CRO and cross-function teams to facilitate site engagement and recruitment activities. Ensure site training/communications are occurring as needed
- Supervise and directly or indirectly manage CRA and CTA staff
- Acts as primary point of escalation for resolution of trial management and operational issues
- Oversees overall study progress, data collection and cleaning activities for all trials
- Prepares study reports and provides ongoing updates for leadership team/meetings
- Supports continuous improvement processes and consistency e.g., by ensuring that lessons learned are shared across trials within the assigned therapeutic indication, across indications as well as across compounds in collaboration with the CMO
- Bachelor’s degree in health or Life Sciences required, advanced degree is a plus
- Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management)
- Experience with CRO selection and management is critical and prior experience working with a CRO is a plus
- Experience in working in an outsourced model, including overseeing CROs and other vendors.
- Excellent written and verbal communication skills, acting globally in a culturally relevant fashion
- Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines
- Experience in immunology and/or oncology drug development highly desired
- Global Strategic Drug Development experience and understanding
- Strong interpersonal and stakeholder management skills
- Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry
- Pro-active problem solver - demonstrated ability to identify and resolve issues, identify and mitigate risks, able to handle conflicts
- Strong organizational skills, able to manage multiple and varied tasks and prioritize workload with attention to the holistic/ helicopter view but also able to dive into the details when needed
- Strong people management skills, leadership skills and team player.
- Line management experience is a plus