Head of Clinical Development, Psychiatry

Head of Clinical Development, Psychiatry

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 / larry@rftgroup.ie The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and MedTech industries. http://www.rftgroup.ie