(3 Days Left) Associate Director ClinicalDevelopment ...

Job Description Clinical Development AssociateDirector Essential Pharma are looking for an Associate Director,Clinical Development to join us! The Clinical Development AssociateDirector to drive the implementation of the clinical developmentstrategy for our Hu14.18 program in high-risk neuroblastoma. Thisrole will be pivotal in not only the execution of our clinicaltrials and corresponding regulatory interactions, but also inestablishing a KOL management system and a cross-functionalcollaboration effort within Essential. This position will have yousupporting investigator meetings, site visits, regulatoryinteractions, and key stakeholder engagement. Apply today! What YouWill Do - Participate as a key component in setting the developmentstrategy for Hu14.18 in high risk neuroblastoma - Lead theexecution, and oversight of global clinical trials for Hu14.18 inhigh risk neuroblastoma. - Serve as clinical lead oncross-functional project teams including regulatory, clinicaloperations, medical affairs, and commercial colleagues. - Providestrategic 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 teamsthroughout the drug development lifecycle. - Contribute to thepreparation of INDs, CTAs, briefing books, regulatory submissions,and publications. - Serve as the medical monitor for Hu14.18clinical trials, ensuring patient safety, data integrity, andcompliance with regulatory standards across the US and selected EUcountries. - Engage with investigators, site staff, and key opinionleaders (KOLs) to ensure high-quality study conduct andrecruitment. - Analyse clinical trial data, provide medicalinsights, and participate in safety monitoring, including review ofSAEs (Serious Adverse Events) and emerging efficacy data. -Represent the company in scientific meetings, advisory boards, andregulatory interactions as required. What We Do Essential Pharma isan international specialty pharmaceutical company dedicated tomaintaining access to clinically differentiated, niche medicines insmall patient populations. Our high-impact portfolio includes over300 medicines covering ten therapeutic areas, with a focus on thecentral nervous system (CNS), gastroenterology, ophthalmology, andrare diseases. Our products treat patients in more than 70countries. We are proactive in identifying low volume,difficult-to-manufacture therapeutic products, and late-stageclinical development assets that target rare diseases. Our recentacquisition of Renaissance Pharmaceuticals is a significantmilestone for Essential Pharma, the groups second product fortreatment of a rare disease, and the first development-stage assetin 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 ouroffices in Surrey UK, Malta, France, Spain and Switzerland. WhatYou Will Bring - MD (or equivalent medical degree) is required. -Board-certified (or eligible) in Oncology or Pediatric Oncology ishighly preferred. - Experience in neuroblastoma is highlydesirable. - Strong experience of clinical development experiencein the pharmaceutical or biotechnology industry. - Proven trackrecord in leading global clinical trials and working withregulatory authorities (FDA, EMA). - Strong scientific acumen,clinical judgment, and ability to interpret and communicateclinical data. - Willingness and ability to travel 50–60%internationally (EU and US). - Excellent communication,collaboration, and leadership skills. What We Offer - CompetitiveSalary - Hybrid Working: We offer flexibility and trust from dayone, with a balance of remote and office-based work. We understandthat different roles have different requirements and are committedto providing additional flexibility as needed. This will bediscussed during the initial interview process. - £150 towards yourhome office – claim purchases back on expenses. - HealthcareInsurance - Pension – you contribute 5% and we offer 5%. - LifeInsurance – lump sum (tax free) death benefit of 4 x basic salary.- Enhanced Family Leave - Enhanced Sick Pay - Annual Leave – 26days - Discretionary Annual Performance Bonus What To Expect - Wewholeheartedly embrace agile working, recognizing that it enablesindividuals to bring their authentic selves to work. Our commitmentto living by our values forms the bedrock of our inclusive culture,where everyone's voice is valued and respected. - Treating eachother as adults fosters a sense of autonomy and responsibility,while our inherent social nature is nurtured through engaginggroups and events. We understand the significance of forgingconnections in the workplace, and our dedication to facilitatingthese bonds is underscored by regular access to our CEO. Groundedin the principles of dynamism, responsibility, trustworthiness, andcollaboration, our values guide our interactions. Furthermore, ourunwavering dedication to employee growth and learning is evidentthrough our commitment to personalized development plans, as webelieve in fostering an environment where all individuals canthrive. - Right from the interview stage, we encourage candidatesto ask us questions, as we understand that it's just as importantfor us to be the right fit for you as it is for you to be the rightfit for us.