Position Details:

• Title: Manager, Clinical Operations (Patient Recruitment)
• Location: Hybrid, New York, NY

Company Overview

Founded 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 Role

The Manager, Patient Recruitment is a member of the Clinical Operations team and is responsible for overseeing patient recruitment to support enrollment in clinical studies in collaboration with patient recruitment vendors and sites.

A successful Manager in Patient Recruitment takes initiative in recruitment strategies, identifies challenges and proactively makes adjustments or decisions to meet study enrollment goals. The position will report to the (Assoc/Sr) Director, Clinical Operations.

Key responsibilities will include:

• Set up study recruitment plans/operations during study start up including site recruitment and central recruitment strategies.
• Evaluate patient recruitment vendors and provide oversight/coordination with vendors throughout the study.
• Develop and review study and site recruitment materials (design elements and written content of flyers, posters, newsletters, ads, etc.).
• Regularly interact with clinical study sites to support individualized site recruitment needs.
• Track progress and success of various recruitment tactics with study enrollment goals in mind.
• Identify new recruitment strategies as needed and lead efforts in recruitment challenges.
• Communicate with various internal and external personnel (i.e., study staff, site personnel, CTM).
• Participate in study team meetings and provide updates to senior personnel.
• Participate in creation, review, and revision of clinical SOPs.
• 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 $130,000 to $150,000, plus equity and benefits.

Experience Requirements

• Bachelor’s degree, preferably in a life science
• 2+ years experience in patient recruitment in a pharmaceutical company, CRO, patient recruitment vendor or similar organization, 4+ overall years in clinical research
• Experience in recruiting 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
• Creative and 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
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Internally motivated, with a passion for mental health
• Routinely takes initiative

Travel Required

• Travel may be required (approximately 5%)

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.

Position Details

• Title: Senior Associate, Clinical Operations
• Location: New York City

Company Overview

Founded 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 Role

The Senior Associate, Clinical Operations is a key member of the Clinical Operations team, with responsibility for supporting the operational aspects of one or more clinical trials. The Senior Associate will support the Clinical Trial Manager, CRAs, and the investigational sites.

This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement. 

Key responsibilities will include:

• Assist clinical team during all phases of a clinical study (feasibility, start-up, maintenance, and close-out)
• Support field-based clinical research associates
• Participate in vendor and study team meetings, including drafting meeting minutes, as needed
• Collect and review essential regulatory documents
• Submission and tracking of documents to central IRB
• Distribute materials to study sites, as directed
• Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment)
• Review and maintain documents in the Trial Master File (TMF)
• Support internal data review, as needed
• Participate in creation, review, and revision of clinical SOPs
• Assist in preparation and coordination of Investigator Meetings, as needed
• Additional responsibilities 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 $70,000 to $100,000, plus equity and benefits.

Experience Requirements

• At least 1 year of clinical research experience within a pharmaceutical company or CRO or at least 3 years of experience as a clinical research coordinator
• 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 in a fast-paced environment
• 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 5%)

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 Values

Operate 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.

Position Details

• Title: Field Clinical Research Associate
• Type: Contract or Contract-To-Hire
• Location: Regionally based (priority to hire East Coast and Central)

Company Overview

Founded 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 Role

The Field Clinical Research Associate (CRA) is a member of the Clinical team, with responsibilities for monitoring site data of one or more clinical trials and ensuring sites are compliant with applicable regulatory requirements and Good Clinical Practice.

A successful CRA is detail oriented, makes risk-based decisions, takes initiative, and keeps an eye on the big picture while focusing on the details.

Key responsibilities will include:

• Perform on-site monitoring visits, such as evaluation visits, SIV, IMV, and COVs along with timely and comprehensive site visit reports.
• Ensure site maintains an accurate inventory and accountability of investigational drug and clinical supplies.
• Ensure sites are conducting the study according to the protocol with high-quality data collection processes and excellent attention to patient safety.
• Coordinate with the in-house team to provide ongoing site support.
• Coordinate with the in-house team to maintain site compliance with study timelines, metrics, and plans.
• Identifies and communicates trends, risks, and deviations. Facilitate resolution of problems, queries and action items including identification of cause and actions to prevent recurrence.
• Support and train other CRAs, as needed.
• Support the in-house team as needed (eg, recruitment strategies, UAT of CRFs, remote data review).
• 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. For full-time roles, we offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.

Experience Requirements

• Bachelor’s degree, preferably in a life science
• At least 4 years of clinical trial experience within a pharmaceutical company or CRO, including at least 2 years of on-site monitoring experience and experience with risk-based and hybrid monitoring models.
• Strong understanding of clinical quality assurance principles and practices is preferred
• 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 proactively communicate and effectively collaborate across functions and job levels
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Internally motivated, with a passion for mental health
• Routinely takes initiative

Travel Required

• Domestic travel is required (approximately 75%)

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 Values

Operate 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.

Position Details

• Title: Associate Director, Clinical Operations
• Location: New York City preferred (we’re open to remote arrangements for exceptional candidates)

Company Overview

Founded 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 Role

The 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 Values

Operate 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.

Position Details

• Title: Director, Clinical Development (MD required)
• Location: New York City preferred (remote arrangements may be considered)

Company Overview

Founded 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 Role

The Director, Clinical Development is a key member of the Clinical team, with responsibility for providing medical oversight of Transcend’s clinical trials and advancing the clinical development of assigned compounds/indications. This role will work closely with the clinical operations team and study sites by acting as their assigned study’s medical monitor.

This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement. A successful candidate is forward thinker, who takes initiative, and leads with the end in mind. This position will report to the Sr. Vice President, Clinical Development.

Key responsibilities will include:

• Lead the development and execution of clinical trial protocols for assigned programs, ensuring scientific rigor and regulatory compliance.
• Provide medical oversight for assigned clinical trials, including acting as the medical monitor.
• Proactively review clinical trial data to ensure patient safety and data quality.
• Analyze, interpret, and communicate clinical trial data to inform key decisions, providing clear recommendations to guide clinical development strategy.
• Contribute to authoring of key clinical documents: protocols, investigator’s brochure, clinical study reports, regulatory submissions, and publications.
• Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives.
• Support creation, review, and revision of clinical development SOPs.
• In collaboration with the clinical operations team, 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 $225,000 to $300,000, plus equity and benefits.

Experience Requirements

• MD or equivalent with 5+ years drug development experience in a pharmaceutical company, with 2+ years’ experience in neuroscience-related indications. Candidates with relevant experience in academia, or a related environment may be considered.
• Board-certified psychiatrist preferred
• Knowledge of FDA and global regulatory requirements and guidelines (e.g., MHRA, EMA) and clinical development processes
• Preferred experience participating in meetings with regulatory authorities, including preparing meeting materials and meeting preparation
• Proficient knowledge of GCP/ICH, drug development process
• Experience working in a small team, fast-paced team

Key Competency Requirements

• Strong analytical and problem-solving skills, with a data driven approach to decision making.
• 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
• 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 Values

Operate 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.