Job 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 which includes.
· leading the clinical development plan, the clinical programs, protocol designs, validation of outcome tools, budgeting activities and outsourcing partner management.
· providing 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.