POSITION OVERVIEW

The Clinical Research Manager drives the clinical development strategies for investigational products by leading protocol design, analyzing clinical trial data, and guiding study execution. They develop strong relationships with principal investigators (PIs) and key opinion leaders (KOLs) and stay informed on emerging science and regulatory issues. With expertise in clinical trials, they ensure compliance with Good Clinical Practice (GCP) and provide clinical training for stakeholders. This role involves collaborating across departments, leading data reviews, and participating in site interactions, requiring a detail-oriented, proactive approach and strong leadership in a fast-paced environment.

 

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the VP of Clinical Research. 

 

RESPONSIBILITIES

  • Responsible for driving clinical development strategies and execution of assigned investigational products.
  • Develops the study protocol synopsis, leads the analysis of benefit/risk for clinical development protocols and the final study protocol validation and protocol amendments; supports the clinical operations team during feasibility and study execution.
  • Identifies and builds relationships with principal investigators (PI) and key opinion leaders (KOL) in drug development. Seeks out external resources to gain perspective on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs.
  • Develop in-depth knowledge of etiology, natural history, diagnosis, and treatment of disorders. Holds strong expertise in the disease areas by attending scientific conferences and ongoing review of the literature.
  • Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape.
  • Leads data review of trial data, including eligibility review; ensures continuous real-time review of aggregated data during clinical trial conduct.
  • Supports clinical trials and participates in site interactions and education (specific disease areas, drug mechanisms of action, protocol requirements, safety management guidelines, etc.). Provides clinical training for internal stakeholders and clinical trial sites.
  • Fulfills GCP and compliance obligations for clinical conduct and maintains all required training.
  • Authors/drafts clinical content for CSRs, regulatory reports, briefing books, and submission documents to support closure, clinical narratives, reporting, and filling of the study.

 

KEY DUTIES AND RESPONSIBILITIES

  • A bachelor’s degree in a related scientific field is required; an advanced degree is preferred. 
  • Minimum of 3 years of clinical research experience in psychiatry; minimum of 3 years of industry experience in drug development or biomedical research experience in academia.
  • Expertise in clinical trials: a working understanding of statistical principles, demonstrated ability to perform literature research, analyze and author clinical trial publications; thorough knowledge of the whole processes of clinical trials, clinical research concepts, practices, and GCP and ICH Guidelines.
  • Proficiency in using Excel, Word, SharePoint, clinical trial management systems, and related software tools; detail-oriented, analytical, and proactive, with the ability to identify issues and implement effective solutions.
  • Proven success record in Phase I-IV clinical research studies, and trial design Experience communicating and interacting with investigators, KOLs, and advisors.
  • Proven ability to represent the Company's interests effectively in interactions with partners and regulatory agencies.
  • Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
  • Must have strong consensus-building skills and the ability to lead multi-disciplinary teams toward sound decision-making.
  • Ability to work collaboratively with cross-functional teams to support the management of large volumes of data.
  • Ability to operate and thrive in a fast-paced and hands-on environment; demonstrated flexibility.
  • Demonstrated success in taking initiative in a team setting.
  • Comfortable with ambiguity, yet self-motivated and timeline-driven.
  • Ability to travel up to 25% as needed.

 

Compensation and Benefits

What we offer:

  • Industry competitive compensation
  • Performance-base bonuses
  • Stock options
  • Employee Stock Purchase Plan
  • 401K plan
  • A collaborative and innovative work environment at the forefront of biotech advancements.

 

Give your best, live wholesomely:

  • Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
  • FSA and HSA
  • Basic Life Insurance 2x Earnings & AD&D
  • Employee Assistance Program
  • Healthcare advocates group to help navigate the healthcare system

 

Work-Life Balance:

  • Unlimited paid time off
  • Flexible work schedule
  • Remote work option
  • Paid Holidays
  • Mental Health Days
  • Winter shutdown
  • Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

 

The anticipated salary range for candidates who will work remotely is $140,000 to $200,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance.  Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook.  Eligibility requirements for these benefits will be controlled by applicable plan documents.

 

 

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally.

Evening and weekend work as necessary.

Potential travel of approximately 5-25%

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

 

All Employee’s have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA) Poster.

 

About Vistagen

Vistagen (Nasdqa: VTGN) is a neuroscience-focused biopharmaceutical company dedicated to pursuing a pioneering approach to the development and commercialization of groundbreaking therapies for psychiatric and neurological disorders based on our deep understanding of nose-to-brain neurocircuitry. Our clinical-stage pipeline consists of intranasal product candidates from a new class of potential neuroscience therapies called pherines. Designed exclusively as nasal sprays, each of our pherine product candidates is centered on our innovative approach to addressing neuroscience disorders with the nose as a new portal for the administration of novel, rapid-onset neuroactive therapies that do not require systemic absorption or binding to neurons in the brain to achieve desired therapeutic effects. Microgram-level doses of our pherine nasal sprays rapidly activate chemosensory neurons in the nasal cavity to impact fundamental neurocircuitry in the olfactory system and the brain with a differentiated safety profile observed in all clinical studies completed to date. Our goal is to develop and commercialize a broad and diversified pipeline of innovative neuroactive pherine therapies for multiple highly prevalent neuroscience indications, such as social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause, with limited or inadequate current treatment options to meet the needs of millions of underserved patients in the U.S. and worldwide. 

Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression, and several other CNS disorders.