Ad/D Clinical Operations

Position Overview:

Reporting to the Sr. Director, Clinical Operations, this individual will function as a cross-functional study team lead for the clinical trial program, responsible for delivery of all clinical trial operational activities, potentially across multiple studies. This role should demonstrate strong matrix management skills, confidence in working independently, and a proven ability to champion a team to deliver on key study milestones. In addition, this individual will be responsible for operating within budget and in accordance with established timelines and quality standards. The ideal individual will have hands-on operational experience with a diverse work ethic to adapt to 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 reports to the Sr. Director, Clinical Operations.

Responsibilities:

• Study Planning and Management. Coordinate and actively participate in the development and updating of study-related documents (investigator brochure, clinical protocols, informed consent forms, case report forms, clinical study reports, amendments, adverse event reporting, site training manuals) and analysis plans (including data collection and management); Monitor study progress and maintain timeline from initiation through publication of study results; work very closely with the clinical lead to advance the studies.

• Quality control. Responsible for development, training, implementation and compliance of Standard Operating Procedures; Develop quality control processes and monitoring plans to ensure that all clinical activities are compliant with Good Clinical Practices and regulatory guidelines. (Oversight of the CROs)

• Clinical Trial Budgeting. Work with the finance department on the development and negotiation of trial site budget and clinical trial agreements; Forecast and manage clinical trial budgets and FTE costs; Ensure accurate accruing of study costs; Review vendor invoices against contract and work completed; Oversee reconciliation of site payments against patient visits to ensure accurate payments; Identify and communicate variances

• Trial Site Management. Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; Lead effective communications with trial sites for specimen tracking, study conduct, and timely data review to identify trends and discrepancies; Contributes to the development of abstracts, presentations, and manuscripts for studies

• Vendor Management. Responsible for collection and preparation of all information needed to facilitate selection, on-boarding and management of CRO and vendors for outsourced activities; develop statements of work, budgets and timelines; Responsible for gap analysis, performance management, risk management and issue resolution.

Qualifications:

• BA/BS required in a scientific/medical field, or equivalent work experience. CNS study experience is highly desirable.

• At least 8+ years of experience in managing global clinical trials at all stages of development within the biopharma industry.

• Demonstrated ability to successfully lead and manage clinical trials from start-up through close-out, including all financial tracking and reporting activities.

• Deep understanding of clinical trial design, protocol development and review.

• Significant experience with cross-functional leadership and clinical teams, including leading data review, database lock, regulatory, clinical research, and study reporting activities.

• Strong vendor management experience required given many accomplishments will come from external resources.

• Experience in maintenance of a submission-ready eTMF is required.

• Quality Assurance, SOP and study plan writing, CAPA preparation and closure is highly desirable.

• Strong team management skills, ability to lead, and train teams at a cross-functional level.

• Experience with Inspection readiness for various Health Authority inspections, including FDA and EMA highly desired.

• Ability to wear multiple hats, including focusing on detailed day-to-day tasks without losing sight of the big picture.

• Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations.

• Knowledge of GDPR and how to apply appropriate practices to clinical trials.

• Strong leadership ability and character to build relationships in a matrix environment, ability to multi-task in a dynamic and fast-paced environment.

• Excellent interpersonal, written, and verbal skills required.

• Working experience/knowledge of timeline management tools (e.g., Smartsheet).

• Willing to travel domestically and internationally occasionally.

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 & Observances

• Winter shut-down

• 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 $160,000 to $190,000 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.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as a general description of benefits and other compensation, and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

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.

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.

About Us:

Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen's pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on neurons in the brain.

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

At Vistagen, we emphasize that mental health is foundational to living vibrant and healthy lives. We believe that healthy minds create healthy communities, and our core goal at Vistagen is to radically improve mental health and well-being worldwide - One Mind at a Time. We are change-makers committed to improving lives by developing innovative, science-based mental health care medicines with the potential to make the impossible, possible - to empower and support patients and their caregivers to achieve faster-acting efficacy without the side effects and safety concerns associated with current treatment options for anxiety and depression.