Senior​/Director, Regulatory Pre-award Strategy - US​/Europe - Remote

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Join us!

This is a leadership role, accountable for directing business development and pre‑award activities, developing them into compelling and competitive proposal offerings leading to bid defenses. Pre‑award activities include designing and driving regulatory strategies, overseeing proposal development and approving pre‑award deliverables. The role also requires designing and implementing a department‑wide business development training and coaching program for various roles within the department.

• Have and apply knowledge of global start‑up and regulatory activities to pre‑award customer deliverables, resulting in a differentiated advantage for bid defense and award
• Attend and provide leadership in bid defense meetings and presentations
• Collaborate with Regulatory team leadership, Therapeutic Area leadership, Business Development, Project Management, Site Management and other functions to develop comprehensive pre‑award site activation strategies
• Develop and implement a comprehensive department‑wide training and coaching program in collaboration with internal stakeholders
• Train and coach department team members on pre‑award activities to expand pre‑award skills and increase flexibility when assigning qualified resources to pre‑award work
• Achieve operational and financial performance targets related to proposal budgets and strategies
• Provide department resource projections and coordinate with the resourcing team to ensure pre‑award staffing plans and forecasts are accurate and adequate
• Proactively interact cross‑organizationally to develop and learn about emerging business, regulatory, therapeutic, and operational strategies that improve service to our internal and external customers
• Instill confidence in our customers during the proposal and bid process through knowledgeable and accurate communication of our startup strategy, including global / country regulatory requirements
• May help develop and implement cross‑functional initiatives for continuous process and quality improvements
• May have line management responsibilities

• Demonstrated strong ability to define, organize, and develop complex Regulatory Affairs strategies into effective customer deliverables
• Strong ability to collaborate effectively among multiple functions and personalities to achieve organizational goals
• Demonstrated strong experience in effectively persuading internal and external customers and engaging in difficult conversations with desired results
• Demonstrated ability to manage activities and people in ambiguous and time‑sensitive situations
• Strong experience in Regulatory Affairs is required, and experience with at least one cross‑functional department, such as Regulatory Compliance, Feasibility, Site Management, Project Management, or Patient Recruitment, is preferred
• Interest and adaptability to drive innovative solutions for our customers, such as with…