Senior Director of Pharmacovigilance
MAPS Public Benefit Corporation
Sales & Business Development
Remote · United States
Posted on Friday, May 26, 2023
About Lykos Therapeutics
At Lykos Therapeutics, we are committed to making an impact on people’s lives. We envision a world where there are more tools available for the treatment of mental health and where conversations about mental health are destigmatized. We aspire to challenge the status quo through the development of novel therapies and therapeutic approaches to treat mental health conditions. Our initial focus is developing investigational MDMA-assisted therapy for adults living with PTSD. If approved by the FDA, MDMA-assisted therapy could be a potential new approach to treating PTSD, a condition that hasn’t had a new treatment option in decades.
MDMA-assisted therapy has been designated a Breakthrough Therapy by the FDA and the results of our two pivotal Phase 3 clinical trials were published in Nature Medicine. MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.
Lykos is a public benefit corporation (PBC), with a dual mandate to generate shareholder value and public benefit. As a PBC, we consider the impact of our decisions on society just as we think about financial implications. We balance the interests of our many stakeholders including our employees, healthcare providers, therapists, investors and others. This means that we look through a public benefit lens with all that we do.
Why work for Lykos Therapeutics?
With 30+ years of experience researching psychedelic-assisted therapies, we remain committed to the rigorous pursuit of evidence-based development of novel approaches. We value impact, integrity, care, and openness and hold public benefit at the center of everything we do. We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, arrest or conviction record, military and veteran status, religions, abilities, and perspectives and are committed to building a supportive, equitable, and accessible workplace.
Lykos has a distributed workforce that uses technology and periodic in-person gatherings to stay connected. We look for people who believe in our mission, are comfortable with and skilled at remote work and collaboration, and ready to step into a dynamic and fast-paced work environment.
Senior Director of Pharmacovigilance Executive Summary
The Senior Director of Pharmacovigilance will lead the development of MAPS PBC’s drug safety program and they will report directly to our Chief Scientific Officer. The Sr. Director of PV will bring significant experience in navigating FDA pre-approval inspections for new drug launches and will have strong working knowledge of PV regulatory requirements. The Sr. Director will optimize procedures and practices for programs to monitor and report on PV quality and compliance. This role will implement processes for the management of all PV controlled procedures, PV trainings, CAPAs, and inspection-related activities.
The successful candidate will work closely with cross-functional teams (ie. Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Commercial) to assure that PV activities are conducted in compliance with regulatory requirements, PV Quality Management Systems, and established internal procedures with a patient safety perspective first
- Lead the PV department and vendors in preparation for product launch in the U.S.
- Lead PV planning, implementation, and management of drug safety activities to support clinical development of company products and actively contribute to corporate risk management related to drug safety.
- Contribute to implementation and management of REMS and Risk Management Plans, ensuring that product benefits outweigh possible risks.
- Direct the development, preparation and review of; periodic and annual safety reports (e.g., DSUR, PADER), investigator communications, product labeling/package inserts and other reports as necessary that relate to product drug safety.
- Provide expert drug safety input into all critical documents for clinical development plans of products (e.g., clinical study, protocols and amendments, ICFs, IBs, IMPDs, INDs, CTAs)
- Manage PV budgets and contracts with outsourced vendors.
- Monitor industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global regulatory compliance.
- Mentoring team towards continuous improvement/enhancement of PV work procedures consistent with good pharmacovigilance practices for regulatory inspection readiness
- Lead development of PV compliance programs and quality tools to enhance global PV quality and adherence to SOPs and regulations.
- Design a global PV training program, including implementation, tracking, maintenance, and effectiveness checking of all PV training activities.
- Advanced degree required.
- 13+ years of experience in the pharmaceutical industry (CNS or psychiatry experience a plus) with preferably a minimum of 5+ years in leadership positions in drug safety and pharmacovigilance in the clinical trial and post-marketing environments
- Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU); European Economic Area (EEA); Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines.
- Experience interacting with global regulatory authorities, including but not limited to FDA, EMA, MHRA, and BfArM.
- Experience with managing and influencing cross-functional teams. Proven ability to develop internal relationships, as well as external relationships with clinical sites, Key Opinion Leaders, and outsourced vendors.
- A dynamic leader who is highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast and well-founded decision-making on a vast number of multidisciplinary issues.
- Skilled at working within an entrepreneurial environment that is mission-driven, results-focused, and research-oriented.
- Excellent communication and time management skills, including working efficiently in a dynamic environment subject to quickly changing priorities and potentially conflicting deadlines.
- Strong interpersonal skills and ability to work with all levels of the organization.
Competitive benefit package includes:
Paid Time Off (PTO)
Medical, dental, vision, and life insurance
Employer funded mental health HRA
Home Office Stipend
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.