Central Operations Head (COH)

Tango Therapeutics•Boston, MA

18h•Hybrid

About The Position

We are seeking a Central Operations Head (COH) to provide strategic leadership across clinical drug supply, Clinical Trial Agreement (CTA), and eTMF management to support global clinical development programs. This role partners cross-functionally with Clinical, Regulatory, Legal, Technical Operations, and Operational Excellence to ensure alignment on trial needs, risk management, and execution priorities. You will oversee end-to-end delivery across trials, define outsourcing and vendor strategies, and ensure performance through KPIs, KRIs, and governance. This role is accountable for driving operational excellence, ensuring inspection readiness, and maintaining compliance with global regulations and internal standards. As a leader, you will build and develop a high-performing team, establish scalable processes and best practices, and foster a culture of accountability, innovation, and continuous improvement in a fast-paced biotech environment.

Requirements

12+ years of trial management experience with 5+ years in leadership position
Bachelor’s degree in Life Sciences, Pharmacy or related field (required).
Significant experience working in global clinical development organization
Significant experience in outsourcing and oversight
Expert knowledge in ICH GCP and GMP
Expert knowledge in computer technologies to plan, forecast, and track documents/ material on all levels
Expert knowledge in risk assessment and management on program and trial-level
Familiarity with clinical trial systems (e.g., CTMS, eTMF, IRT) and operational metrics, KPIs, and KRIs
Familiarity with clinical supply planning, forecasting, and inventory tools
Independent judgment and objectivity
Strong analytical and influencing skills
Ability to drive accountability across functions
Strong leadership and interpersonal skills

Nice To Haves

Advanced degree, e.g., MS, PharmD, PhD, MBA (preferred)

Responsibilities

Provide strategic direction for clinical drug supply management, clinical trial agreement (CTA) management, and eTMF management activities to support clinical development objectives across all programs and trials
Collaborate with Trial Management, Regulatory Affairs, Clinical Development, Legal, and Technical Operations to align on trial needs and deliverables
Collaborate with Operational Excellence & Clinical Compliance and GMP compliance to align on risk assessment, metrics, KPIs, and KRIs for management of clinical drug supply, CTAs, and eTMF
Define and implement outsourcing strategies (incl. Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs) and vendors) in partnership with VP of Global Clinical Operations and Head of Clinical Sourcing & Contracting
Define functional goals, performance metrics, and resourcing strategies. Drive innovation including adoption of risk-based approaches
Oversee end-to-end execution of drug supply-/ CTA-/ and eTMF management across clinical trials, ensuring timely, high-quality, and inspection-ready deliverables
Track CRO, CMO, and vendor performance using metrics, KPIs, and KRIs; lead SMO governance meetings to address escalated issues and drive continuous improvement
Establish and maintain best practices and standards throughout the trial lifecycle
Ensure adherence to global regulatory requirements, GCP and internal SOPs. Lead audit and inspection readiness for drug supply-/ CTA-/ and eTMF management and implement effective oversight models for internal teams and outsourced partners. Perform internal quality reviews and ensure inspection readiness of trial documentation
Lead, coach, and develop a high-performing team. Foster a culture of collaboration, continuous learning, and accountability, while supporting career progression and succession planning across the function
Select, manage, and govern external vendors. Define expectations, monitor performance via KPIs, and drive accountability through governance forums to ensure quality, timelines, and cost-effectiveness