Job Description

Position Overview:

The Senior Director, Medical Monitoring (MM) and Pharmacovigilance (PV) will serve as a thought leader, with a high level of experience as a medical professional with a strong ability and broad knowledge of MM, global drug safety, and post-marketing safety surveillance. This role will lead all medical activities including, but not be limited to, interaction with clinical research sites and CROs, MM of the clinical studies, initial safety review of adverse events, medical review of clinical data, management of drug safety vendors, review of source documents, preparation of documents for submission to regulatory authorities, medical monitoring support to clinical trial sites for questions related to clinical trial, and emergency unblinding. This individual will apply deep medical and clinical expertise to ensure high-quality decision-making and will work collaboratively across the enterprise to align drug development programs with leadership goals and ensure efficient, end-to-end execution of clinical development plans. This role is pivotal in shaping leading-edge clinical science applied to CNS drug development. The individual will build and lead the MM and PV group in this role.

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 SVP, Clinical Research and Development.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

• Provide medical leadership to the Clinical group and multi-disciplinary study teams.
• Manage and lead the MM & PV group, manage resources, and budget pertinent to the PV activities.
• Serve as a medical monitor/advisor of ongoing clinical trials.
• Ensure compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory requirements, for the processing and reporting of adverse events in coordination with regulatory affairs.
• Responsible for the overall clinical risk management and safety surveillance of all future investigational products.
• Provide medical review and advice of post marketing safety data.
• Prepare/oversee medical monitoring plans and present the study protocol's safety in the IM meetings and site initiation activities.
• Act as 24/7 available medical contact person for questions related to clinical trial and for emergency unblinding.
• Medical review of coding, ensure accuracy of MedDRA coding of adverse events' terms, medical history, and WHO Drug coding of concomitant medications.
• Medical review of eCRF related to clinical and safety data.
• Medical review of individual case safety report (ICSR): adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), adverse drug reactions (ADR), causality assessment, signal detection, case narrative, aggregate reports, medical review of listings of safety data.
• Write/review the relevant safety sections of the NDA and different types of regulatory meeting packages.
• Provide medical input and review of annual reports, PADER, PSUR, DSUR, other benefit risk assessment reports, updates of package insert/label, summary of product characteristics, and investigator's brochure.
• Prepare and review the answers to questions from Health Authorities, medical input in Risk Management Plan (RMP).
• Participate in DSMB preparation and activities.
• Collaborate with clinical operations and clinical research to optimize study designs for operational efficiency, ensuring timely and cost-effective delivery.
• Oversee the design and execution of clinical research studies and review key clinical documents (e.g., protocols, clinical study reports, regulatory submissions).
• Maintain current knowledge of all applicable drug safety guidelines and regulations (FDA, ICH, IRB, EMA).
• Establish the necessary MM &PV SOPs and work guidance.

Qualifications:

• MD or DO, with relevant post-graduate clinical training.
• US board-certified physician (preference in psychiatry) with 10+ years of relevant work experience in pharmaceutical/biotech industries.
• Experience in NDA and IND submissions is preferred.
• Knowledge of medical and therapeutic terminology.
• Deep understanding of the drug development process (preferred in CNS therapeutic areas).
• Strong knowledge of regulatory requirements (GCP, ICH guidelines) and worldwide safety regulations.
• Experience in managing MM &PV budgets and financial risk in clinical research.
• Ability to review emerging data and proactively ensure the delivery of high-quality study results.
• Skilled communicator and leader, able to articulate ideas clearly and integrate team feedback.
• Excellent writing skills, and ability to convey moderately complex technical information clearly to others.
• Ability to work independently in a dynamic and fast-moving environment.
• Proficient in meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.

Compensation and Benefits

What we offer:

• Industry-competitive compensation
• Performance-based 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 HAS
• Basic Life Insurance 2x Earnings and 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 $285,000-$330,00 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. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as 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.

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)

OVERVIEW OF THE COMPANY

Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at .

Job Tags

Full time, Work experience placement, Casual work, Local area, Remote work, Worldwide, Flexible hours, Weekend work, Afternoon shift,

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