Senior Clinical Trials Manager; Biotechnology Oncology

Senior Clinical Trials Manager – Clinical Operations

The Senior Clinical Trials Manager (Study Delivery Lead) is responsible for planning, executing, and reporting clinical trials, ensuring delivery in time, quality, and within budget while meeting protocol and regulatory requirements. The role drives end‑to‑end study design, manages global delivery strategy, oversees vendors, and leads a cross‑functional study delivery team.

• Lead and manage the global study delivery strategy, including country selection, diversity, patient engagement, and recruitment plans.
• Drive vendor assessment, selection, engagement, and oversight; ensure compliance with ICH/GCP, laws and internal SOPs.
• Develop and manage study budgets within project allocations; prepare materials for internal governance and financial reviews.
• Lead investigator meetings and other study related meetings; participate in governance meetings.
• Identify and communicate resource gaps; lead risk management and quality activities to maintain study compliance and inspection readiness.
• Collaborate with matrix partners, Clinical Sciences, and Data Management to develop data cleaning strategies and protocol development inputs.
• Provide proactive oversight of CRO and vendor performance.
• Support Clinical Operations Program and Indication Lead with study level status updates, focusing on delivery to corporate and project objectives.
• Enhance processes and ways of working; contribute to innovation, training, and problem‑solving initiatives.

• Minimum of 9 years of related experience in life sciences, including 7 years in clinical research and at least 4 years of study management (alternatives: 7 years experience with 2 years PhD/Pharm
  
  D or 9 years BA/BS).
• Experience designing, managing, and closing clinical studies; strong protocol development skills.
• Proven ability to work independently and in a matrix environment; excellent organizational, planning, and communication skills.
• Demonstrated knowledge of ICH/GCP, regulations, and guidelines; experience managing multinational trials and interacting with external vendors (CROs, contract labs).
• Strong analytical skills and business communication expertise.

• BA/BS in biological sciences or related field with a minimum of 9 years experience.
• MA/MS in biological sciences or related field with a minimum of 7 years experience.
• PhD/Pharm
  
  D in biological sciences or related field with a minimum of 2 years experience.
• Equivalent combination of education and experience.

• Leadership and matrix collaboration skills.
• Ability to manage risk, drive continuous improvement, and deliver results under tight timelines.
• Effective interpersonal and communication skills, both written and oral.
• Strong organizational and project‑planning abilities.
• Adaptive mindset, curiosity, and resilience in dynamic environments.

None

• Travel may be required up to 20% in support of clinical study activities.

Base salary range: $172,000 – $245,000 annually, commensurate with geography, experience, and internal equity. Additional benefits include a 401(k) plan, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus, equity participation, 15 accrued vacation days in the first year, 17 paid holidays, and up to 10 sick days.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, or disability in accordance with federal, state, and local law.