Senior Director, Clinical Operations

Celebrating 40+ years!

Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

We're seeking a Senior Director, Clinical Operations to lead Clinical Project Managers and Clinical Research Associates teams, drive strategic decisions, manage departmental budgets while ensuring profitability and compliance. The Senior Director will spearhead process improvements that enhance quality and operational efficiency.

The primary responsibilities of this position include, but are not limited to, the following:

• Leadership & Team Management
  • Leads the Clinical Project Management and Clinical Research Associates teams.
  • Provides oversight for selected trial portfolios and program management for selected clients.
  • Provides mentorship and development opportunities for project team members. 
• Strategic Planning & Resource Management
  • Optimize resource allocation and proactively identify skill gaps to maximize team effectiveness across multiple trials.
  • Provides strategic guidance and direction to project teams to ensure client/project goals are met and contracts are properly executed.
• Stakeholder Engagement & Communication
  • Maintains strong, effective, and collaborative relationships with both internal and external stakeholders. 
  • Reinforces cross-functional collaboration and communication to meet project/business goals.
• Risk Management & Communication
  • Keeps Vice President, Global Clinical Operations abreast of any key risks/issues and proposes solutions, in real time.
  • Supports study teams in problem solving, escalation and resource allocation. 
• Analytics & Performance Management
  • Responsible for development, implementation, analysis and trending of operational metrics and KPIs used to monitor study activities.
  • Drives adherence to and expansion of operational metrics and KPIs.
• Proposal Development & Financial Management 
  • Partner with Business Development on proposal preparation and budget reviews; participate in BID defense meetings and coach junior staff in this regard.
  • Participate in departmental budget activities, provide Business Operations and Executive Management with required information for project resourcing and revenue projections.
• Operations & Continuous Improvement
  • Plans, develops and implements process improvement initiatives based on audit and inspection findings, data, KPIs and metrics. 
  • Participates in related professional conferences.

Level of Education

• Bachelor’s degree is required, preferably in a life science related field, Master’s degree or higher preferred.

Prior Experience

• A minimum of 15 years of progressive clinical development experience in a CRO (only) or CRO + pharmaceutical (combined) environment, required.
• A minimum of 10 years of direct line management, required.
• A successful track record of resourcing/building, developing, mentoring, and leading high performing, multi-disciplinary teams.
• A minimum 5 years experience in oncology is required.

Skills and Competencies

• Executive leadership skills driving change and process by example.
• Strategic, forward-thinking mindset to anticipate challenges and proactively develop solutions.
• Demonstrates ability to build and maintain effective relationships with others and establishes collaborative partnerships.
• Exceptional communication, leadership, and decision-making skills with strong organizational and negotiation abilities.
• Strong analytical/budgeting skills.
• Proven ability to deliver results and complete tasks with minimal guidance.
• High level of agility and diplomacy.
• Motivated and trustworthy.
• Extensive working knowledge of the end-to-end drug development process, GCP and ICH guidelines, FDA/EMA and other applicable regulations.
• Proficient with Microsoft Office; easily adopts new technologies.

What We Offer

At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $180,000-$220,000. The actual salary offer will be based on a number of factors, including but not limited to the candidate’s qualifications, experience, skills, and competencies for the role.

This position is not eligible for relocation or company provided sponsorship.

Theradex is an Equal Opportunity Employer.