Director, Regulatory Pre-Award Strategy (Remote, Europe/Canada)

About the role

Worldwide Clinical Trials is seeking a senior leader to direct business development and pre‑award activities across Europe and Canada. The role focuses on designing regulatory strategies, overseeing proposal development, and leading bid defenses to secure new contracts.

Key responsibilities

• Design and drive regulatory strategies for global start‑up and pre‑award activities.
• Oversee proposal development, approve pre‑award deliverables, and lead bid defense meetings.
• Collaborate with Regulatory, Therapeutic Area, Business Development, Project Management, and Site Management teams to create comprehensive site activation strategies.
• Develop and implement a department‑wide training and coaching program for pre‑award processes.
• Train and coach team members to expand pre‑award skills and improve resource flexibility.
• Achieve operational and financial targets related to proposal budgets and strategies.
• Provide resource projections and coordinate staffing plans with the resourcing team.
• Interact cross‑organizationally to stay abreast of emerging regulatory and therapeutic strategies.

Required profile

• Extensive knowledge of global start‑up and regulatory activities.
• Proven experience leading pre‑award and bid defense processes.
• Strong collaborative skills with multiple functional teams.
• Ability to develop and deliver training programs.
• Track record of meeting operational and financial performance goals.

Required skills

What we offer

• Opportunity to shape regulatory strategy at a global CRO.
• Remote work flexibility.
• Collaborative, inclusive culture focused on innovation.