Director – Regulatory Pre-Award Strategy
Worldwide Clinical Trials
Director – Regulatory Pre-Award Strategy
Worldwide Clinical Trials
Contract research organization delivering clinical trials
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.
Why Worldwide
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.
What you will do
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
What you will bring to the role
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 decentralized clinical trials, remote and local home healthcare models, and direct-to-patient technologies
Aptitude or proficiency in using and learning digital and software systems
Your experience
University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory, or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
Minimum of twelve (12) years of global clinical pharmaceutical industry experience, including 3 years of demonstrated skills and competency in managing teams in a global environment
Experience in Regulatory Affairs in Pharma, CMC and/or Preclinical (Toxicology) knowledge
Experience in Scientific advisory support & briefing packages prep
Deep knowledge of the US & Global regulatory landscape is a plus
Demonstrated ability to inspire effective teamwork and motivate personnel within a matrix system
Available for domestic and international travel, including overnight stays
Valid passport
Fluent in local office language and in English, both written and verbal
Broad knowledge of the drug development process and client needs
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
Contract research organization delivering clinical trials
Worldwide Clinical Trials is a contract research organization that provides drug development services for pharmaceutical and biotech companies, focusing on running clinical trials to bring new medicines to market. Its core work centers on the science and logistics of clinical trials—designing studies, coordinating sites and investigators, and managing data and regulatory processes to advance drug candidates through development. The company differentiates itself through its specialized, science-driven approach and global expansion achieved via strategic acquisitions, building a larger network and broader capabilities to support complex trial programs. After a history of ownership changes, including a re-launch in 2007 and a majority stake sale in 2023, the firm aims to grow further under new ownership while continuing to offer focused clinical trial services that support medical advancement.
Explore more opportunities at Worldwide Clinical Trials