Transcend Therapeutics discovers, develops, and delivers next-generation psychoactive medicines to work toward a world in which people no longer suffer from neuropsychiatric disease. Transcend focuses on developing 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 already advanced our lead compound into an approved study in PTSD, with plans to expand into depression and other indications. We already have real-world data showing that our lead product provided significant benefit in 85% of a case series of patients with PTSD and depression. In addition, we have begun the process of disseminating our preclinical and clinical data at the world's premier psychiatry conferences.
Transcend’s leadership team includes the first scientist to receive federal funding for clinical psychedelic research in 54 years; drug development executives with pivotal contributions to >20 FDA approvals and seven major biopharma exits totaling $4 billion in combined 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
As a key member of the management team, the Clinical Development Lead, Psychiatry will lead the design and execution of clinical studies in the Psychiatry space – this includes a key pilot study in PTSD that was recently approved by the MHRA in the UK. Critical responsibilities will be the management of CROs and engagement with International Key Opinion Leaders (KOLs).
The Clinical Development Lead, Psychiatry would report directly to the Chief Medical Officer, Michael Perelman. Michael has made significant contributions to the approval of twelve drugs, two of which generated >$1B in yearly sales. At Schering-Plough, acquired by Merck for >$40B, Michael oversaw drug development for two therapeutic areas that comprised 45% of the company's revenue. Earlier in his career, he worked as a reviewer at the Medicines Control Agency (UK's version of the FDA). Before joining Transcend, Michael served as the Chief Medical Officer at a number of companies, including Archimedes Pharma which was acquired for ~$400M and Emisphere which was acquired by Novo Nordisk.
Essential duties and responsibilities
- As a small organization (today), this role is both strategic and tactical; the person in this role must be very much hands-on.
- Provide key clinical leadership for all psychiatry activities.
- Work collaboratively with members of the Senior Management Team.
- Design and develop clinical strategies that will identify the strengths and weaknesses of our compounds, creating development programs that will lead to successful regulatory submissions and approvals.
- Design protocols that will provide critical information on the efficacy and safety of our products.
- Connect with KOLs
- Manage Clinical Research Organizations (CROs) that will provide the routine management of Transcend’s clinical trials. This will include:
- identifying and validating research sites;
- ensuring that all studies are managed to International Good Clinical Practice (GCP) standards;
- working with Investigators, DSMBs, etc;
- developing good relationships with investigators;
- managing Advisory Panels;
- participating in data review and writing critical documentation.
- Work with members of the Senior Management Team to create documents that will support the programs and which will provide Regulatory Authorities with the necessary information to gain endorsement of the clinical program.
This is a great opportunity to step into a high-impact role on the early team of Transcend Therapeutics. We offer competitive cash and equity compensation; medical, dental, and vision insurance; unlimited vacation and sick time; and more.
Who you are/what you bring:
- Mission-driven and passionate about reducing the burden of psychiatric and neurological illness.
- Greater than 7 years pharma or biotech experience, with at least 3 years in a senior management role in clinical development.
- Candidates with extensive experience as an academic investigator will also be considered.
- CNS development experience is strongly preferred.
- Experience with mental health patient care, preferably with PhD or PsyD in clinical psychology, would be a plus.
- Experience in:
- clinical development;
- clinical protocol writing;
- managing clinical trials;
- submissions to and meetings with Regulatory Authorities, plans;
- data analysis;
- A record of successful regulatory interactions.
- Excellent written and verbal communication skills.