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Senior Director of Clinical Development
2 months ago
Job Title: Senior Director of Clinical Development
Job Summary:
The RFT Group, BioPharmaceutical Division, is seeking a highly experienced Senior Director of Clinical Development to lead our client's clinical development efforts. As a key member of the Executive Management Team, you will be responsible for driving the development of next-generation therapies from early-stage development through to registration, commercialization, and product launch.
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.
- Oversee the Clinical Development function, including non-clinical, clinical pharmacology, early-stage development, late-stage development, and life-cycle management.
- 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 SOPs, WI, and compliance with federal and local guidelines and ICH GCP.
Requirements:
- Additional PhD with training in Psychiatry or Neuroscience is preferred.
- Proven track record in early and late-stage clinical development, registration, and commercialization.
- Regulatory experience, including up-to-date knowledge in current regulatory processes and rules.
- Regulatory strategy experience related to psychiatric disorders would be an advantage.
- Experience in building and leading a clinical development/science function, resourcing, and budgetary management.
- Experience in the management of outsourced development programs.
- Proven aptitude in continuously developing own scientific and medical knowledge.
- Excellent scientific and medical writing skills.
About The RFT Group:
The RFT Group, BioPharmaceutical Division, specializes exclusively in the recruitment of scientists, engineers, and executives for the biotechnology, pharmaceutical, and MedTech industries.
