Job Description
This position will provide the rare opportunity for a high-performing, innovative thinker to revolutionise the treatment of neuropsychiatric disorders by transforming next-generation mental health therapies from concept to reality. Psychiatry is a complex field and we’re working towards a new paradigm of psychiatric treatment. For this reason, we’re looking for 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 but also 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 role activities will include:You are accountable for the design of 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.You are accountable for leading GH’s Clinical Development Function including non-clinical, clinical pharmacology, early development, phase 3 development and LCMThis includes:Leading the development of GH’s overall clinical development plan, the TRD phase 3 program, 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 X-functionally with GH’s Clinical operations, Medical Affairs, Access and Commercial, Biostats, Regulatory, CMC and Quality Functions, and being supported by GH’s Program Management Function.You will be responsible for developing and analysing the Non-clinical and Clinical Development Function’s budget strategy and accountable for the actual costs incurred. This includes managing the resourcing strategy of the function as well as identifying the key development activities to deploy funding and resources to.You will be responsible for managing outsourced development programmes and ensuring the related budgets are accurate, up to date and activity performed/expenditure incurred is reported in a timely manner.With a hands-on leadership style, you will drive clinical program design and execution with focus on excellence, quality, speed, value and financial performance. You will 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.You will, as needed, support the development and implementation of new initiatives and strategic direction of the Clinical Development Function and you will liaise across GH Research to optimize processes, timelines and resources. You will build collaborative relationships with cross-functional leaders across Medical, Regulatory, Finance/Legal, CMC/Device, IP and GH’s other functions.You will ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal and local guidelines and ICH GCP.You will represent the Company as needed to a variety of medical, scientific, business, investor and government groups/agencies.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 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.Ability to understand, explain and communicate clinical program concepts and put into detailed plans.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 programmes.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. #J-18808-Ljbffr