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Job Description
Lead Clinical Development Function to transform next-generation mental health therapies from concept to reality.
GH is seeking a hands-on development leader to work closely with the CMO and other members of our team to continue the direction for our non-clinical, early and late-stage clinical development to create a commercial product that is both satisfactory to regulators and exciting for the psychiatric community.
This requires experience and a track record of successful development in psychiatry, an obsession with creating something new and groundbreaking, and a commitment to all stakeholders invested in our mission and to fostering a positive transformation within the healthcare industry.
Key Responsibilities:
- Design GH'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 GH's 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 be accountable for the actual costs incurred.
- Manage outsourced development programs and ensure the related budgets are accurate, up-to-date, and activity performed/expenditure incurred is reported in a timely manner.
- Drive clinical program design and execution with focus on excellence, quality, speed, value, and financial performance.
- Oversee the identification of critical data and processes, the 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 and 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 a variety of medical, scientific, business, investor, and government groups/agencies.
Requirements:
- MD or PhD with training in Psychiatry or Neuroscience with proven academic excellence.
- A track record that includes early and late-stage clinical development, registration, and commercialization, with experience of working with therapies for psychiatric disorders, with a strong understanding of current treatment paradigms and emerging therapeutic approaches for depression.
- Regulatory experience, including up-to-date knowledge in current regulatory processes and rules - experience in regulatory strategy related to psychiatric disorders would be an advantage.
- Hands-on leadership style while staying close to clinical execution and being able to bring a strategic perspective.
- Experience in building and leading a non-clinical and clinical development function and managing the related costs and resources.
- Experience in the management of outsourced development programs.
- A blend of conventional pharma plus biotech experience and the attitude and 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.
- An entrepreneurial, business-oriented mindset.
- A strong fit with the GH Research team and willing to "roll their sleeves up".
- Resilient, energetic, and enthusiastic, a good communicator, with excellent leadership, management, and influencing skills.