Planet Pharma · 6 hours ago
Director, Clinical Operations
New Haven, CT
Full-time
Onsite
Director/Executive
$150/hr - $168/hr
10+ years expPlanet Pharma is seeking a Director/Senior Director of Clinical Operations to provide strategic and operational leadership for oncology clinical programs. This role is responsible for the end-to-end execution of clinical trials, ensuring regulatory compliance and high-quality delivery while managing CROs and cross-functional teams.
BiotechnologyHealth CarePharmaceutical
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
Serve as the primary escalation point for operational risks, CRO performance issues, and timeline threats
Lead and influence cross-functional teams to drive timely decision-making
Contribute to portfolio-level planning, including startup sequencing, resourcing strategy, and risk prioritization
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 inspection readiness
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
Qualification
Required
10–15+ 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 required
Preferred
Advanced degree preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
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