We are currently seeking an experienced Global Clinical Supply Professional at Vistagen who will work closely with numerous core team members to ensure clinical supplies are packaged, labeled and distributed for multiple ongoing clinical trials. This role will work closely with our Clinical Operations team to develop pharmacy manuals and relevant sections in clinical trial protocols that serve as the key piece for clinical trial sites and ultimately patients to ensure correct drug attributes, dose formulation and proper administration are available. This position will serve as a core member of multidisciplinary project teams and will directly impact strategy, timing, and execution of all planned or ongoing clinical trials. This position will closely interface with internal and/or external departments such as Quality, Chemistry Manufacturing and Controls (CMC), Regulatory Affairs, Clinical Operations. It is expected that all packaging, labeling and distribution will occur through Contract Development Manufacturing Organizations (CDMOs) to ensure dosing plans as well as inventory are made available to support clinical trial strategy and timelines globally. This person will be responsible for actively managing all clinical supply investigations, deviations, Corrective Actions and Preventative Actions (CAPA’s), and any required Change Control documentation associated with clinical supplies, when required. The incumbent will ensure all activities occur in compliance with the appropriate SOPs and regulations.
This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report directly to the Senior Vice President, Head of CMC.
KEY DUTIES & RESPONSIBILITIES
Key responsibilities of this role include, but are not limited to:
- Contract packaging, labeling, and international shipping/distribution operations for IP (Investigational Product) ensuring on time delivery to support clinical trials at Vistagen.
- Leads the planning, creation, and maintenance of IP supply project plans, based on study forecasts from Clinical Operations.
- Assists Quality Assurance (QA) activities related to opening and closing of deviations, investigations, CAPA’s, change controls, label and product specifications, and others as required.
- Direct and monitor clinical supply contractor set up, progress and implements corrective actions when issues arise.
- Manages development and implementation of IVRS supply and drug return strategy with contractors and sites.
- Manages clinical supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date, and that final product reconciliation is accurately completed.
- Interacts with clinical study CROs and clinical sites regarding supply needs, site-facing documentation/education and storage and return of clinical supplies.
- Develop and or maintain Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials.
- Ensures that key supply project milestones are met; negotiates and communicates supply plan details and timelines to internal and external customers and partners.
- Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects.
- Participates as SME, working closely with Quality, for clinical regulatory audits related to supply chain.
- Represents Clinical Supplies on global clinical project teams.
- Assist with forecast planning and real time inventory management of clinical and ancillary supply, identify process improvement opportunities, recommends pathways for solutions, and drives idea generation, proposals, and implementation.
- Reviews clinical supply-related CDMO quotes/scopes of work and reconciles corresponding invoices in collaboration with other internal and external partners
- Manages IP-related activities involving temperature excursions and expiry extensions, including communication of those activities to all applicable parties.
- Acts as unblinded Sponsor contact for all clinical study and supply interactions.
EDUCATION, EXPERIENCE AND SKILLS:
- BS/BA degree, Master’s degree or PharmD with prior clinical supply, hospital, or investigational drug service experience preferably in a bio-tech environment.
- Minimum 7+ years of related pharmaceutical industry experience.
- A successful track record in investigational drug services (preferably in the pharma/biotech space).
- Demonstrated experience in global inventory management and forecasting.
- Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance documents as they relate to packaging, labeling and distribution of pharmaceutical products.
- Ability to effectively prioritize and deliver on tight timelines.
- Outstanding problem-solving abilities.
- Detail-oriented, with good organizational and project management skills.
- Strong oral and written communications skills.
- Proficient with MS Word, PowerPoint, Excel.
- Strong leadership, project planning, negotiation and presentation skills.
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to forge cross-functional working relationships with internal and external project partners.
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
- Unlimited paid time off
- Flexible work schedule
- Remote work option
- Paid Holidays
- Mental Health Days & Observance of World Mental Health Day
- 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 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.
The anticipated salary range for candidates who will work remotely is $125,000 to $185,000 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 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.
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.
Vistagen Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.