Head of Clinical Development, Psychiatry, DublinClient: The RFT GroupLocation: Dublin, IrelandJob Category: OtherEU work permit required: YesJob Reference: 4881bd5bb911Job Views: 61Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Our client, an innovative publicly listed clinical-stage Biotech company focused on the development of their novel and proprietary drug products in psychiatry, now has approval to hire a Head of Clinical Development. Reporting to the CMO and working closely with the Executive Management Team and Board of Directors, this hire will support the transformation of next-generation therapies from early-stage development through to registration, commercialisation and product launch.The successful candidate will provide hands-on leadership and strategic direction to non-clinical, early-stage and late-stage clinical development teams; driving clinical program design, strategic oversight and execution to create commercial products that meet regulatory approval.Additionally, this hire will represent the Company as needed to a variety of medical, scientific, business, investor and government groups/agencies.This Executive Leadership role will appeal to a high performing, innovative and strategic thinker; who has led clinical science teams, and successfully designed and led end-to-end clinical registration programs in neuroscience.This is a rare opportunity to create something groundbreaking and transformative within the healthcare industry and for those patients with unmet needs in this therapy area.Responsibilities of Head of Clinical Development:Lead the design of the company’s clinical development plans for all assets and on-going or new indications, while meeting standards of excellence for ethics, scientific merit, quality and regulatory compliance.Lead the Clinical Development function including non-clinical, clinical pharmacology, early-stage development, late-stage development and life-cycle management.Provide scientific support and oversight of the studies in collaboration with the CMO, such as oversight of operational activities, medical monitoring, biostatistics, results interpretation and reporting, while collaborating cross-functionally with internal functions.Lead development and analysing the non-clinical and clinical development function’s budget strategy, resourcing strategy and accountable for the actual costs incurred.Drive clinical program design and execution with focus on excellence, quality, speed, value and financial performance.Ensure quality and adherence to SOPs, WI, and compliance with federal and local guidelines and ICH GCP.Requirements for Head of Clinical Development:MD with residency in psychiatry. Additional PhD with training in Psychiatry or Neuroscience is preferred.Proven track record that includes early and late-stage clinical development, registration, and commercialisation; with experience of working with therapies for psychiatric disorders, with a strong understanding of current treatment paradigms and emerging therapeutic approaches for depression and including several years in a senior leadership role.Regulatory experience, including up-to-date knowledge in current regulatory processes and rules. Regulatory strategy experience related to psychiatric disorders would be an advantage.Hands-on leadership style with depth of Clinical Program leadership experience; including clinical study design, strategic oversight and execution of such to successful regulatory approval.Experience in building and leading a clinical development / science functions, resourcing and budgetary management.Experience in the management of outsourced development programmes.A blend of conventional pharma plus biotech experience; and the ability to apply learnings of both environments to build a young Biotech company.Proven aptitude in continuously developing own scientific and medical knowledge. Strong analytical capability. Excellent scientific and medical writing skills.Superb communicator, with excellent influencing and stakeholder management skills.Travel as required.To discuss this exciting opportunity in confidence, please contact Larry on +353 (0) 1 2302400. The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and MedTech industries.
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