Senior/Director, Regulatory Pre-award Strategy
Senior/Director, Regulatory Pre-award Strategy

Senior/Director, Regulatory Pre-award Strategy

Full-Time 100000 - 144000 Β£ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Lead innovative pre-award strategies and develop competitive proposals for global clinical trials.
  • Company: Join a pioneering CRO dedicated to improving lives through innovative solutions.
  • Benefits: Competitive salary, diverse work environment, and opportunities for professional growth.
  • Why this job: Make a real impact in the healthcare industry while collaborating with a passionate team.
  • Qualifications: 12+ years in clinical pharma, strong leadership, and excellent communication skills required.
  • Other info: Dynamic role with opportunities for travel and continuous learning.

The predicted salary is between 100000 - 144000 Β£ per year.

We are 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.

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.

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 site activation 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.
  • Experience with requirements and expectations of 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 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.
  • 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.

Exact compensation may vary based on skills, experience, and location: $129,258,020.00.

We love knowing that someone is going to have a better life because of the work we do.

Senior/Director, Regulatory Pre-award Strategy employer: Worldwide Clinical Trials

At Worldwide Clinical Trials, we are not just a global CRO; we are a community of innovators dedicated to improving lives through our pioneering approaches. Our supportive and inclusive work culture fosters collaboration and creativity, providing ample opportunities for professional growth and development. With accessible leadership and a commitment to diversity, we empower our employees to thrive and make a meaningful impact in the world of clinical research.
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Contact Detail:

Worldwide Clinical Trials Recruiting Team

StudySmarter Expert Advice 🀫

We think this is how you could land Senior/Director, Regulatory Pre-award Strategy

✨Tip Number 1

Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.

✨Tip Number 2

Prepare for interviews by researching the company and its culture. Understand their mission and values, and think about how your experience aligns with them. We want to show that we’re not just a good fit for the role, but for the team too!

✨Tip Number 3

Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. We can’t stress enough how important it is to articulate your skills and experiences clearly during the real deal.

✨Tip Number 4

Don’t forget to follow up after interviews! A simple thank-you email can go a long way in leaving a positive impression. It shows that we’re genuinely interested in the position and appreciate the opportunity to connect.

We think you need these skills to ace Senior/Director, Regulatory Pre-award Strategy

Leadership Skills
Business Development
Regulatory Strategy Development
Proposal Development
Training and Coaching
Collaboration Skills
Communication Skills
Project Management
Operational Performance Management
Resource Projection
Cross-Functional Collaboration
Adaptability
Digital Literacy
Clinical Trial Knowledge
Team Management

Some tips for your application 🫑

Tailor Your Application: Make sure to customise your CV and cover letter for the Senior/Director role. Highlight your relevant experience in regulatory strategies and team management, showing us how you can bring value to our mission.

Showcase Your Leadership Skills: We want to see your ability to inspire and motivate teams. Share specific examples of how you've led projects or initiatives in the past, especially in a global environment, to demonstrate your fit for this leadership role.

Be Clear and Concise: When writing your application, keep it straightforward. Use clear language and avoid jargon where possible. We appreciate well-structured applications that get straight to the point while showcasing your expertise.

Apply Through Our Website: Don’t forget to submit your application through our careers page! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to hear from you!

How to prepare for a job interview at Worldwide Clinical Trials

✨Know Your Stuff

Make sure you brush up on your knowledge of global start-up and regulatory activities. This role is all about developing compelling proposals, so being able to discuss these strategies confidently will set you apart.

✨Showcase Your Leadership Skills

Since this is a leadership position, be prepared to share examples of how you've successfully managed teams in the past. Highlight your ability to inspire and motivate others, especially in challenging situations.

✨Collaborate Like a Pro

This role requires working with various teams, so demonstrate your collaboration skills. Be ready to discuss how you've effectively worked across departments to achieve common goals and how you handle differing opinions.

✨Be Ready for Tough Questions

Expect some challenging questions during the interview. Prepare for scenarios where you had to engage in difficult conversations or persuade stakeholders. Show them you can navigate these situations with ease and professionalism.

Senior/Director, Regulatory Pre-award Strategy
Worldwide Clinical Trials
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