Job Description
**Clinical Development Leader for Neuropsychiatric Disorders**
We are seeking a highly experienced and innovative thinker to lead our clinical development efforts in neuropsychiatric disorders. This is a rare opportunity to revolutionize the treatment of complex mental health conditions by transforming next-generation therapies from concept to reality.
The ideal candidate will have a strong track record of successful development in psychiatry, with experience in early and late-stage clinical development, registration, and commercialization. They will be responsible for designing and executing clinical development plans, leading cross-functional teams, and ensuring regulatory compliance.
**Key Responsibilities:**
- Design and execute clinical development plans for all assets and indications, meeting standards of excellence for ethics, scientific merit, quality, and regulatory compliance.
- Lead the Clinical Development Function, including non-clinical, clinical pharmacology, early development, phase 3 development, and LCM.
- Develop and analyze the Non-clinical and Clinical Development Function's budget strategy and manage actual costs incurred.
- Manage outsourced development programs and ensure related budgets are accurate and up-to-date.
- Drive clinical program design and execution with focus on excellence, quality, speed, value, and financial performance.
- Oversee the identification of critical data and processes, assessment of risks to protocol execution and clinical delivery, risk and issue tracking, and risk and issue mitigation strategies.
- Support the development and implementation of new initiatives and strategic direction of the Clinical Development Function.
- Liaise across GH Research to optimize processes, timelines, and resources.
- Build collaborative relationships with cross-functional leaders across Medical, Regulatory, Finance/Legal, CMC/Device, IP, and GH's other functions.
- Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP.
- Represent the Company as needed to medical, scientific, business, investor, and government groups/agencies.
**Requirements:**
- MD or PhD with training in Psychiatry or Neuroscience and proven academic excellence.
- Track record of successful development in psychiatry, including early and late-stage clinical development, registration, and commercialization.
- Strong understanding of current treatment paradigms and emerging therapeutic approaches for depression.
- Regulatory experience, including up-to-date knowledge of current regulatory processes and rules.
- Hands-on leadership style with ability to bring a strategic perspective.
- Experience in building and leading a non-clinical and clinical development function and managing related costs and resources.
- Experience in managing outsourced development programs.
- Blend of conventional pharma and biotech experience, with ability to be effective in a lean, small company environment.
- Experience in working and influencing cross-functionally.
**Personal Qualities:**
- Proven aptitude in continuously developing own scientific and medical knowledge.
- Strong analytical capability.
- Excellent scientific and medical writing skills.
- Flexible, able to adjust, embrace, and drive change.
- Entrepreneurial, business-oriented mindset.
- Strong fit with the GH Research team and willingness to "roll their sleeves up".
- Resilient, energetic, and enthusiastic, with excellent leadership, management, and influencing skills.