Head of Clinical Development, Neuropsychiatry
2 months ago
Executive Leadership Opportunity in Clinical Development
The RFT Group, a leading recruitment agency for the biotechnology and pharmaceutical industries, is seeking a highly experienced and strategic thinker to fill the role of Head of Clinical Development, Neuropsychiatry for a innovative clinical-stage Biotech company.
About the Role
This is a rare opportunity to lead the clinical development function, including non-clinical, clinical pharmacology, early-stage development, late-stage development, and life-cycle management, for a company focused on developing novel and proprietary drug products in neuropsychiatry.
Key Responsibilities
- Lead the design of the company's clinical development plans for all assets and ongoing or new indications, ensuring excellence in 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 studies in collaboration with the Chief Medical Officer (CMO), including operational activities, medical monitoring, biostatistics, results interpretation, and reporting.
- Develop and analyze the non-clinical and clinical development function's budget strategy, resourcing strategy, and ensure accountability for actual costs incurred.
- Drive clinical program design and execution with a focus on excellence, quality, speed, value, and financial performance.
- Ensure quality and adherence to Standard Operating Procedures (SOPs), Work Instructions (WI), and compliance with federal and local guidelines and ICH GCP.
Requirements
- MD with residency in psychiatry. Additional PhD with training in Psychiatry or Neuroscience is preferred.
- Proven track record in early and late-stage clinical development, registration, and commercialization, with experience working with therapies for psychiatric disorders.
- Regulatory experience, including up-to-date knowledge of current regulatory processes and rules.
- Hands-on leadership style with depth of Clinical Program leadership experience, including clinical study design, strategic oversight, and execution to successful regulatory approval.
- Experience in building and leading a clinical development/science function, resourcing, and budgetary management.
- Experience in the management of outsourced development programs.
- A blend of conventional pharma plus biotech experience, and the ability to apply learnings from 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.
About The RFT Group
The RFT Group is a specialist recruitment agency for the biotechnology, pharmaceutical, and MedTech industries. We have a proven track record of delivering high-quality candidates to our clients, and we are committed to providing exceptional service and support throughout the recruitment process.
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