Responsibilities
- Provide operational leadership and accountability for oncology clinical trials, including FIH and dose-escalation studies.
- Translate asset and governance decisions into executable operational plans, timelines, and resourcing strategies.
- Lead and influence cross-functional teams to drive timely decision-making.
- Lead operational planning and execution of Clinical Pharmacology studies (e.g., FIH, SAD/MAD, food effect, DDI, QTc, bioavailability studies).
- Develop and maintain the study operational plan, timelines, and cross-functional deliverables in collaboration with Clinical Pharmacology, Data Management, Biostats, Safety, and Regulatory.
- Coordinate study start-up, site readiness, and operational oversight, including monitoring enrollment, dosing milestones, and data delivery timelines.
- Lead cross-functional study team meetings, track risks and issues, and ensure timely resolution to maintain study timelines.
- Ensure Trial Master File (TMF) completeness and inspection readiness throughout the study lifecycle.
- Provide regular study status updates to program leadership, highlighting progress, risks, and mitigation strategies.
- Lead the end-to-end operational execution of assigned studies from startup through close-out.
- Own study timelines, deliverables, and operational KPIs; proactively identify and mitigate risks.
- Oversee FIH dose-escalation execution, including cohort management and safety review coordination.
- Drive feasibility, country and site strategy, and global startup execution.
- Ensure investigator meetings, SIVs, and training strategies are aligned with study complexity.
- Provide strong oversight and governance of CROs and vendors.
- Partner with Sourcing and Finance on CRO selection, contracting, change orders, and budget oversight.
- Ensure CRO execution aligns with sponsor expectations for speed, accountability, and quality.
- Lead regular vendor governance and performance reviews.
- Ensure studies are conducted in accordance with ICH/GCP, FDA, EMA, and global regulations.
- Partner with QA to ensure readiness inspection.
- Oversee monitoring strategies, data review cadence, and clinical data quality oversight.
- Act as a key operational partner to Clinical Development, Regulatory Affairs, Biometrics, Data Management, and QA.
- Provide clear communication on progress, risks, and decisions.
Requirements
- 15+ years of clinical operations experience in drug development.
- Demonstrated leadership in oncology clinical trials, including FIH and dose-escalation studies.
- Proven experience leading global studies and managing CROs and vendors.
- Experience in fast-paced early development environments.
- Strong leadership, judgment, and decision-making skills.
- Ability to balance speed and accountability.
- Excellent stakeholder management and communication skills.
- Deep understanding of clinical trial operations and regulatory requirements.
- Bachelor’s degree in a clinical or science-based field
Nice to Have
- Advanced degree
Benefits
- competitive package of base and incentive compensation
- comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families
- group medical, vision and dental coverage
- group and supplemental life insurance
Work Arrangement
Hybrid
Additional Information
- This role may be remote, hybrid, or based in New Haven, CT.
