Position Details- Title: Associate Director, Clinical Operations
- Location: New York City preferred (we're open to remote arrangements for exceptional candidates)
Company OverviewFounded in 2021, Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases. Our lead asset TSND-201, a rapid-acting neuroplastogen, is the first and only product to demonstrate rapid, robust, and durable therapeutic effects in PTSD. TSND-201 was granted Breakthrough Therapy designation by the FDA based on Phase 2 results, and we have aligned on a Phase 3 program for TSND-201 in PTSD. Transcend is backed by leading life sciences investors and driven by a mission to create treatments for the millions of people for whom current psychiatric medicines have not worked.
About the RoleThe Associate Director (AD), Clinical Operations is a key member of the Clinical Operations team, with responsibility for overseeing the execution of Transcend's clinical trials. The AD will help drive trial operational strategy. The AD will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by a Senior Director, Clinical Operations when needed.
This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement. A successful AD is forward thinking, takes initiative, and leads with the end in mind. This position will report to the Senior Director, Clinical Operations.
Key responsibilities will include:
- Support the Clinical Trial Manager with planning and strategy for implementation and execution of assigned clinical trials from study startup through close-out
- Oversee day-to-day operations of assigned clinical trials including team interactions with study sites and vendors and act as an escalation point for key issues
- Identify, prepare, and implement departmental process improvement initiatives to improve operational efficiencies
- Provide expertise for drafting, finalization and implementation of clinical documents (ie, Protocol, Clinical Monitoring Plan)
- Oversee various activities and cross-functional collaboration of assigned clinical trials (e.g., monitoring, data management, drug supply logistics, labs, recruitment)
- Manage direct report(s) by providing leadership, vision and mentoring
- Proactively identify clinical data trends and escalate as needed
- Ensure Trial Master File (TMF) maintains regulatory compliance
- Support creation, review, and revision of clinical SOPs
- Ensure that the clinical trials are conducted in a timely fashion and in compliance with SOPs, GCP, regulatory guidelines, company goals, and budget
- All other duties as required
This is a great opportunity to step into a high-impact, high-visibility role on the early team of Transcend Therapeutics. We offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.
The salary range for this role is $180,000 to $210,000, plus equity and benefits.
Experience Requirements- Bachelor's degree, preferably in a life science
- At least 7 years of clinical trial experience within a pharmaceutical company or CRO and at least 4 years in a managerial position
- Experience managing direct reports
- Proficient knowledge of GCP/ICH, drug development process, clinical operations
- Experience executing clinical trials in a small team or at a small pharmaceutical company is preferred
- Experience conducting studies in psychiatry-related indications is preferred
- Previous clinical monitoring experience is preferred
Key Competency Requirements- Excellent verbal, written, communication and interpersonal skills
- Detail-oriented, with a desire to 'get in the weeds' and understand the nuances
- Flexible, able to pivot when needed in a fast-paced environment
- Able to align with company goals and focus on the big picture
- Able to effectively communicate and collaborate across functions and job levels
- Internally motivated, with a passion for mental health
- Routinely takes initiative
Travel Required- Domestic and international travel may be required (approximately 10-25%)
We are committed to building a diverse, inclusive and talented team, free from discrimination. If you're excited about our mission but don't meet 100% of the qualifications above, we encourage you to apply.
Transcend ValuesOperate with good intent. Above all, we aim to reduce suffering. We must remain selfless in pursuit of that noble goal, acting with good intent and assuming the same in our partners and peers.
Proceed with Passion. We're working to usher in an era where people with mental illness have safe and easy access to the treatments they need. Fulfilling that mission demands creative ideas, camaraderie among collaborators, and an understanding that we are all responsible for our individual and team success.
Be willing to work-and learn-together. The problems we're working to solve are complex, and no one person has every solution. Making the best decision as a team is more important than being individually "right." The diversity of our backgrounds and experiences is a strength; when all of those views are synthesized, we can develop new solutions and make better decisions.
Stay focused and flexible. Resourcefulness plays a major part in our success; we can't let unexpected set-backs derail our progress. Think creatively, act ethically, and find a way to get it done.
