Head Of Clinical Operations (Gene Therapy)

Head Of Clinical Operations (Gene Therapy)

A cutting-edge biotechnology Startup firm is looking for a dedicated Head Of Clinical Operations (Gene Therapy) to join our dynamic team. We're pushing the boundaries of science to develop Gene Therapies that address unmet medical needs and improve patients' lives worldwide. If you're passionate about driving transformative research and want to make a lasting impact in the biotech industry, we'd love to see your application.

What You’ll Do

• Work with co-founders and the chief of staff on vision to identify new areas of growth for the organization
• Own and build the Clinical Operations function end-to-end with key KPIs in mind such patient outcomes, patient NPS, patient growth/churn, consultation margins)
• Leverage data to make informed decisions
• Collaborate with the chief of staff and head of growth to design and execute on state expansion strategy
• Drive the design, implementation and documentation of new clinical protocols with medical leadership
• Manage the customer operations team; overtime grow and manage teams and teams of teams; act as an advocate for the medical org directly with the co-founders
• Identify areas of improvements in the medical organizations, implement rapid solutions with tools and collaborate with the head of product to drive new product features (e.g. patient analytics portal, medical clearance, pre-authorization etc.)
• Monitor patient outcomes to support a high level of care for patientsLiaise with the healthcare legal team and monitor federal/state, FDA/DEA regulatory compliance
• Own the prescriber forecasting model, influence and collaborate with the medical organization on hiring, onboarding, training and management of the medical staff (30+ prescribers today)

Who You Are

• Evaluate performance of clinical operations using key performance indicators and implement necessary improvements.
• Mentor, coach, and lead a team of clinical professionals, promoting a culture of collaboration and continuous learning.
• Ensure the highest standards of patient safety and data integrity across all clinical trials.
• Prior experience designing a medical organization and rolling out protocols to support growth and scale
• Provide strategic input into the design and implementation of clinical trial protocols.
• Prior experience in operations with an understanding of the regulatory landscape
• Foster strong relationships with clinical investigators and other external partners.
• A self-starter with a “lean” mindset that thrives in a fast-paced environment solving complex and sensitive patient problems in mental health with an outstanding ability to execute
• 8-12 years of experience in Operations (Gene Therapy)
• Prior experience building, growing and managing a team
• Lead cross-functional teams and work closely with other departments, including R&D, Regulatory Affairs, and Quality Assurance.

What to expect - we aim to align growth with high level of care for our clients

• You will be asked to problem solve and come up with lean solutions
• The scope of your responsibilities will evolve as you grow and shape the role
• Together, we will invest in building trust and a thriving company!
• You are the subject matter of your function and you own it end-to-end
• We favor direct communication style and love to laugh
• We operate in a fast pace of change day-to-day with shifting priorities
• At this stage, we are all ICs with a high level of autonomy
• Our work is meaningful and we see the direct impact of our contributions immediately
• You will have a chance to design your own rhythm while meeting company goals (we encourage taking time off and going on vacation!)
• Cross-functional collaboration with the leadership team is focused on speed and execution while having fun
• You will have opportunity to grow, both personally and professionally through 360 feedback