Senior Director, Clinical Operations

Senior Director, Clinical Operations

Theradex Oncology is seeking a Senior Director, Clinical Operations to provide leadership, direction and support to Clinical Project Managers and Clinical Research Associates teams. The Senior Director provides guidance to functional area leaders and demonstrates a high level of independent decision making. This role is accountable for department budget planning and management, including maintaining study level budget awareness to ensure project profitability and compliance with contractual requirements. The Senior Director will own SOP's, contribute to improvement initiatives and develop solutions to ensure quality and efficiency.

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

• 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.
• Optimizes resource allocation across multiple trials; identifies gaps in resourcing and skill sets within assigned project teams.
• Maintains strong, effective, and collaborative relationships with both internal and external stakeholders.
• Provides strategic guidance and direction to project teams to ensure client/project goals are met and contracts are properly executed.
• 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.
• Reinforces cross-functional collaboration and communication to meet project/business goals.
• 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.
• Supports Business Development with preparation and review of proposals and budgets.
• Participates in BID defense meetings; coaches more junior staff in this regard.
• Participates in related professional conferences.
• Participates in budget activities for the department and provides Business Operations and Executive Management with required information for project resourcing and revenue projections.
• Plans, develops and implements process improvement initiatives based on audit and inspection findings, data, KPIs and metrics.

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 mindset / forward-thinking approach to anticipate challenges and proactively offer solutions.
• Demonstrates ability to build and maintain effective relationships with others and establishes collaborative partnerships.
• Strong communication, organization, negotiation, prioritization, time management and decision-making skills.
• 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.