Clinical Development Associate Director
Essential Pharma are looking for an Associate Director, Clinical Development to join us! The Clinical Development Associate Director to drive the implementation of the clinical development strategy for our Hu14.18 program in high-risk neuroblastoma. This role will be pivotal in not only the execution of our clinical trials and corresponding regulatory interactions, but also in establishing a KOL management system and a cross-functional collaboration effort within Essential. This position will have you supporting investigator meetings, site visits, regulatory interactions, and key stakeholder engagement. Apply today!
What You Will Do
- Participate as a key component in setting the development strategy for Hu14.18 in high risk neuroblastoma
- Lead the execution, and oversight of global clinical trials for Hu14.18 in high risk neuroblastoma.
- Serve as clinical lead on cross-functional project teams including regulatory, clinical operations, medical affairs, and commercial colleagues.
- Provide strategic medical input into trial design, protocol development, and regulatory submissions.
- Collaborate with investigators, KOLs, and external partners to advance the clinical development program.
- Provide medical expertise and guidance to internal teams throughout the drug development lifecycle.
- Contribute to the preparation of INDs, CTAs, briefing books, regulatory submissions, and publications.
- Serve as the medical monitor for Hu14.18 clinical trials, ensuring patient safety, data integrity, and compliance with regulatory standards across the US and selected EU countries.
- Engage with investigators, site staff, and key opinion leaders (KOLs) to ensure high-quality study conduct and recruitment.
- Analyse clinical trial data, provide medical insights, and participate in safety monitoring, including review of SAEs (Serious Adverse Events) and emerging efficacy data.
- Represent the company in scientific meetings, advisory boards, and regulatory interactions as required.
What We Do
Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.
We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.
In December 2024, Essential Pharma announced a €900 million recapitalisation with partners Gyrus Capital, welcoming AlpInvest and new strategic financing from Sixth Street.
Our business is comprised of around 70 people based out of our offices in Surrey UK, Malta, France, Spain and Switzerland.
What You Will Bring
- MD (or equivalent medical degree) is required.
- Board-certified (or eligible) in Oncology or Pediatric Oncology is highly preferred.
- Experience in neuroblastoma is highly desirable.
- Strong experience of clinical development experience in the pharmaceutical or biotechnology industry.
- Proven track record in leading global clinical trials and working with regulatory authorities (FDA, EMA).
- Strong scientific acumen, clinical judgment, and ability to interpret and communicate clinical data.
- Willingness and ability to travel 50–60% internationally (EU and US).
- Excellent communication, collaboration, and leadership skills.
What We Offer
- Competitive Salary
- Hybrid Working: We offer flexibility and trust from day one, with a balance of remote and office-based work. We understand that different roles have different requirements and are committed to providing additional flexibility as needed. This will be discussed during the initial interview process.
- £150 towards your home office – claim purchases back on expenses.
- Healthcare Insurance
- Pension – you contribute 5% and we offer 5%.
- Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
- Enhanced Family Leave
- Enhanced Sick Pay
- Annual Leave – 26 days
- Discretionary Annual Performance Bonus
What To Expect
- We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected.
- Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive.
- Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.
