Transcend Therapeutics is a clinical-stage, neuroscience-focused company developing next-generation psychoactive medicines for neuropsychiatric disease. Transcend develops medicines that are accessible to a larger percentage of patients in need, specifically the tens of millions of patients who already take psychotropic medication. We have real-world data showing that our lead product provided significant benefit to >85% of patients with PTSD and depression. We have already advanced our lead compound into an approved Phase II study in PTSD, with plans to expand into depression and other indications.
Transcend’s leadership team includes the first scientist to receive federal funding for clinical psychedelic research in over 50 years and drug development executives with pivotal contributions to 13 FDA approvals, including the most recently approved drug for depression, and $7B dollars in M&A and public company value. We are backed by AlleyCorp, an incubator and venture capital fund that has founded some of the most transformative companies in New York, including MongoDB, Business Insider, Gilt Groupe, Zola, Nomad Health, and many others. AlleyCorp incubations have collectively raised $1B+ in venture capital with an aggregate value of $30B+.
As a Public Benefit Corporation, we have pledged 10% of founding shares toward nonprofits focused on scientific research and patient access.
About the Role
The Clinical Trial Manager (CTM) is a founding member of the Clinical team, with responsibilities for leading the operational aspects of one or more clinical trials. The CTM will be the primary point person, internally and externally, for Transcend-sponsored clinical trials. The CTM will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the Head of Clinical Development when needed.
This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement. A successful CTM is forward thinking, takes initiative, and leads with the end in mind. This position will report directly to the Sr. VP of Clinical Development.
Key responsibilities will include:
- Plan and lead the implementation of assigned clinical trials from study startup through close-out
- Responsible for the day-to-day interaction with study sites, CROs, and vendors
- Oversee CRA team, and conduct onsite visits as needed
- Select and oversee study vendors, as needed
- Oversee activities related to data management, including CRF/EDC design, data review/query resolution, and internal clinical data review
- Proactively identify clinical data trends and escalate as needed
- Ensure Trial Master File (TMF) is current and maintained
- Support creation, review, and revision of clinical SOPs
- Ensure that the clinical trial is 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 $110,000 to $150,000, plus equity and benefits.
- Bachelor’s degree, preferably in a life science
- At least 3 years of clinical trial experience within a pharmaceutical company or CRO
- Experience in conducting studies in psychiatry-related indications is preferred
- Proficient knowledge of GCP/ICH, drug development process, clinical operations
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
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
- 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.