Clinical Development Lead - Psychiatry

Location: Remote, US or CE

Job: Full-time

HealthMode is seeking a motivated candidate who is passionate about supporting the growth of an innovative company committed to novel therapeutic approaches to psychiatric conditions andimproving clinical development through better measurement. As Clinical Development Lead - Psychiatry you will lead clinical development for drug and device studies in psychiatry indications. You will be responsible for planning and ensuring the execution of the clinical and regulatory program for one or more therapeutic assets; assembling multi-functional teams and leading project meetings in a fast-moving development program. You will work closely with leadership in several departments internally and with partner organizations to facilitate communication and decision making to complete projects on time and on budget. This role is remote.

HealthMode was created to improve clinical trials and healthcare through the development of digital patient measures. We develop products that collect patient data from real-world settings and transform them into quantifiable clinical measures providing evidence for clinical trials and patient care. We follow a 3-step product validation path, 1) product feasibility study, 2) data collection and model development, and 3) clinical validation. On this path, we develop industry and clinical research partnerships that support the development and adoption of the new measures. We integrate regulatory discussions throughout our process to speed up innovation adoption within the pharmaceutical industry.

You will be responsible for:

• Planning the study and regulatory programs and managing the team(s), for one or more drug, device, or combination products
• Forecasting budget and timelines aligned with company strategy
• Working closely with clinical leadership, R&D, and engineering to integrate and sync study timelines with development roadmaps
• Contributing to clinical documentation such as clinical protocols, informed consent, site and patient facing instructions and training materials
• Coordinating with the regulatory and compliance teams, and external consultants as needed
• Running all studies in accordance with internal SOP’s and GCP/ICH guidelines
• Participating in global regulatory strategy and communication
• Overseeing site selection, recruitment and support throughout the trial
• Developing study budgets, documenting and reporting study and site costs
• Participating in program strategy meetings, and ad hoc clinical operations initiatives and programs
• Understanding and communicating the HealthMode product line and digital health development processes to partners

You enjoy:

• Working independently within a distributed team
• Being proactive, target driven and diligent
• Working for multiple stakeholders and managing multiple priorities
• Learning new skills and knowledge domains
• Stretching within your role to grow independently and help the team succeed
• Communicating with colleagues with diverse expertise in a multidisciplinary and multicultural environment
• Working with a wide, diverse network of teams and individuals across continents and time zones, internally and externally to the company
• Leading collaborative projects
• Taking feedback and adapting to changing priorities
• Learning about the broad, rapidly evolving digital health sector

You have:

• A PhD in psychology, MD with experience in psychiatry, MS in psychology with 3+ years related work or research experience
• 4+ years of experience managing clinical trials for a commercial pharma/biotech/CRO company
• Documented training of knowledge of current FDA Regulations
• Working knowledge and understanding of key global regulatory authorities, ICH Guidelines and Good Clinical Practice (GCP).
• Proficient written and verbal communication skills
• Ability to collaborate effectively with cross functional team members and external partners
• A can-do attitude and excellent attention to detail