NEW: Director - Oncology Clinical Development
Exclusive to The Source - register/apply now
We are looking for an experienced oncology clinical development leader to join an exciting development programme on an interim basis and make an immediate impact.
This is a key opportunity for a Director or Senior Director-level clinical development professional who is comfortable operating at a senior level, navigating complex regulatory environments, and providing hands-on leadership across an established cross-functional team.
The successful individual will play an important role in advancing an oncology programme through significant clinical and regulatory milestones, including FDA engagement, IND activities, and Phase 3 development.
The Role
You will provide senior clinical development leadership across the programme, working closely with colleagues across Clinical, CMC and other development functions.
This is a role for someone who can hit the ground running — bringing practical experience, sound judgement and confidence in dealing with regulatory and clinical development challenges, rather than requiring extensive onboarding.
Key areas of focus will include:
- Providing strategic clinical development leadership for an oncology programme, with the opportunity to contribute to US and global development strategy.
- Leading and supporting FDA interactions, including preparation of the development team and navigating different regulatory scenarios.
- Supporting IND submission activities and the transition into later-stage development.
- Potentially leading the programme through regulatory interactions and into/through a Phase 3 study.
- Providing senior-level guidance, mentorship and day-to-day direction to an established development team of approximately 8–10 people.
- Coaching and preparing more junior clinical development colleagues for agency interactions.
- Working closely with Clinical and CMC colleagues to ensure the programme is fully prepared for key development and regulatory milestones.
- Providing pragmatic, senior-level input when navigating complex clinical, regulatory and cross-functional situations.
Requirements
We're keen to speak with experienced oncology clinical development professionals who can bring a combination of strategic thinking, regulatory expertise and hands-on development experience.
Ideally, you will have:
- Director or Senior Director-level experience in clinical development.
- Strong experience in oncology drug development.
- Experience spanning early-stage through later-stage development, particularly Phase 3 and/or approval.
- Demonstrable experience leading or supporting FDA interactions.
- Experience with IND submissions and/or Phase 3 programmes.
- A strong understanding of US regulatory expectations.
- Global clinical development experience, ideally across multiple regions.
- The confidence to work independently and provide immediate leadership within an established team.
- A track record of coaching, mentoring and developing less experienced clinical development professionals.
- Strong cross-functional collaboration skills, particularly across Clinical and CMC.
Why This Role?
This is an opportunity to step into a high-impact leadership position at a pivotal point in an oncology programme.
You'll have the opportunity to use your experience where it matters most, helping shape development strategy, preparing for important FDA interactions and supporting the programme as it progresses towards later-stage clinical development.
If you are an experienced oncology clinical development leader who enjoys complex programmes, senior stakeholder engagement and making an immediate difference, we'd be very interested in hearing from you.
How to Apply
This contract opportunity is exclusive to The Source.
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