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Senior Director - Clinical Operations

WEP Clinical

Full-time
USA, Canada
operations
director
project management
clinical research
leadership
Apply for this position

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The WEP Clinical Senior Director of Clinical Operations provides visionary, global leadership for all aspects of clinical program delivery, including Clinical Project Management, Site Management, and Clinical Monitoring. This role ensures that clinical studies uphold the highest standards of quality, compliance, and operational excellence across all regions, while managing key sponsor relationships and coordinating both internal teams and external vendors.

As a strategic leader, the Senior Director drives operational performance, oversees global study execution, and champions continuous improvement initiatives. This role partners closely with sponsors to deliver studies on time, within scope, and to the highest quality standards. In addition, the Senior Director plays a pivotal role in business development, contributing to proposal strategy, bid defense, and organizational growth initiatives.

The Ideal Candidate:

  • Strategic Thinker

  • Problem Solver

  • Adaptable

  • Collaborative

What You'll Do:

  • Lead and oversee all global clinical operations functions, including Clinical Project Management, Site Management, and Clinical Monitoring, ensuring studies are delivered on time, within scope, and to the highest quality standards.

  • Serve as a senior operational advisor to leadership on feasibility, resourcing, timelines, and risks, providing guidance for portfolio planning and program execution.

  • Act as the primary operational contact for sponsors, maintaining transparency, resolving escalations, and aligning operational strategies with client expectations.

  • Identify, mitigate, and escalate operational risks; ensure adherence to global regulatory requirements (ICH-GCP, FDA, EMA, PMDA) and internal SOPs.

  • Oversee global site selection, activation, monitoring, and performance; drive investigator engagement, timely recruitment, and high-quality data delivery.

  • Implement governance structures, KPIs, and dashboards; monitor performance and drive continuous improvement across regions and programs.

  • Lead global vendor strategy, including selection, contracting, performance management, and integration with internal operations to optimize delivery.

  • Champion adoption of clinical systems (CTMS, eTMF, IRT, eCOA, etc.) and digital tools to enhance operational visibility, efficiency, and decision-making.

  • Drive continuous improvement initiatives, scalable delivery frameworks, and best practices to ensure consistent, compliant, and efficient study execution.

  • Partner with Business Development to develop operational strategies, budgets, proposals, and bid defenses, supporting organizational growth and client engagement.

  • Lead global resource forecasting, capacity planning, and budget management to ensure efficient allocation and cost-effective program delivery.

  • Build, mentor, and lead high-performing global teams, fostering collaboration, accountability, inclusion, and leadership development across Clinical Operations.

What You'll Need:

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (MD, PhD, or MSc) preferred

  • 10+ years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry, with a strong focus on clinical operations, or an equivalent combination of experience, education, and expertise

  • Proven success in leading, scaling, and inspiring global or regional clinical operations teams

  • Strong leadership and people-development skills, with a track record of mentoring high-performing teams

  • Deep expertise in Good Clinical Practice (GCP), clinical trial regulations, and ethical guidelines across Europe

  • Extensive experience managing clinical trial budgets, site feasibility assessments, and vendor partnerships

  • Strategic thinker with exceptional problem-solving, decision-making, and negotiation abilities

  • Demonstrated ability to drive change, implement innovative technologies, and optimize clinical trial operations

  • Excellent communication, collaboration, and stakeholder management skills, with the ability to influence effectively at all levels

What We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

Apply for this position
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About the job

Full-time
USA, Canada
Senior Level
Posted 3 hours ago
operations
director
project management
clinical research
leadership

Apply for this position

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Senior Director - Clinical Operations

WEP Clinical

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The WEP Clinical Senior Director of Clinical Operations provides visionary, global leadership for all aspects of clinical program delivery, including Clinical Project Management, Site Management, and Clinical Monitoring. This role ensures that clinical studies uphold the highest standards of quality, compliance, and operational excellence across all regions, while managing key sponsor relationships and coordinating both internal teams and external vendors.

As a strategic leader, the Senior Director drives operational performance, oversees global study execution, and champions continuous improvement initiatives. This role partners closely with sponsors to deliver studies on time, within scope, and to the highest quality standards. In addition, the Senior Director plays a pivotal role in business development, contributing to proposal strategy, bid defense, and organizational growth initiatives.

The Ideal Candidate:

  • Strategic Thinker

  • Problem Solver

  • Adaptable

  • Collaborative

What You'll Do:

  • Lead and oversee all global clinical operations functions, including Clinical Project Management, Site Management, and Clinical Monitoring, ensuring studies are delivered on time, within scope, and to the highest quality standards.

  • Serve as a senior operational advisor to leadership on feasibility, resourcing, timelines, and risks, providing guidance for portfolio planning and program execution.

  • Act as the primary operational contact for sponsors, maintaining transparency, resolving escalations, and aligning operational strategies with client expectations.

  • Identify, mitigate, and escalate operational risks; ensure adherence to global regulatory requirements (ICH-GCP, FDA, EMA, PMDA) and internal SOPs.

  • Oversee global site selection, activation, monitoring, and performance; drive investigator engagement, timely recruitment, and high-quality data delivery.

  • Implement governance structures, KPIs, and dashboards; monitor performance and drive continuous improvement across regions and programs.

  • Lead global vendor strategy, including selection, contracting, performance management, and integration with internal operations to optimize delivery.

  • Champion adoption of clinical systems (CTMS, eTMF, IRT, eCOA, etc.) and digital tools to enhance operational visibility, efficiency, and decision-making.

  • Drive continuous improvement initiatives, scalable delivery frameworks, and best practices to ensure consistent, compliant, and efficient study execution.

  • Partner with Business Development to develop operational strategies, budgets, proposals, and bid defenses, supporting organizational growth and client engagement.

  • Lead global resource forecasting, capacity planning, and budget management to ensure efficient allocation and cost-effective program delivery.

  • Build, mentor, and lead high-performing global teams, fostering collaboration, accountability, inclusion, and leadership development across Clinical Operations.

What You'll Need:

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degree (MD, PhD, or MSc) preferred

  • 10+ years of experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry, with a strong focus on clinical operations, or an equivalent combination of experience, education, and expertise

  • Proven success in leading, scaling, and inspiring global or regional clinical operations teams

  • Strong leadership and people-development skills, with a track record of mentoring high-performing teams

  • Deep expertise in Good Clinical Practice (GCP), clinical trial regulations, and ethical guidelines across Europe

  • Extensive experience managing clinical trial budgets, site feasibility assessments, and vendor partnerships

  • Strategic thinker with exceptional problem-solving, decision-making, and negotiation abilities

  • Demonstrated ability to drive change, implement innovative technologies, and optimize clinical trial operations

  • Excellent communication, collaboration, and stakeholder management skills, with the ability to influence effectively at all levels

What We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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