Director/Senior Director Global Program Safety Physican (US/EU/IL)

About Prilenia

Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is seeking a Global Program Safety Physician to join its team in the US, Europe, or Israel [KM1] [YN2] .

Prilenia is a flexible, fast-moving team that is advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. The European Medicines Agency (EMA) has accepted Prilenia’s European Marketing Authorisation Application (MAA) for pridopidine for the treatment of adults with HD, and we are continuing discussions with the FDA on the path forward for pridopidine in the U.S. Meanwhile, we are preparing for a global Phase 3 clinical trial in ALS.

Pridopidine has the potential to be the first treatment to have an impact on measures of HD disease progression. Prilenia believes pridopidine’s novel mechanism of action as a sigma-1 receptor agonist also gives it potential in numerous other neurological diseases.

Prilenia has offices in the U.S., Israel and The Netherlands. We are a highly virtual and flexible organization that is mostly remote and encourages team members to work in the ways that make them most effective, with a focus on our common goals and getting the job done.

To learn more about our story and company culture, visit us at https://Prilenia.com

About The Role

We seek a highly qualified and experienced professional to join our team as Director/Senior Director, Global Program Safety Physician (GPSP). This position assists in the successful development, execution and maintenance of safety-related strategies that conform to industry standards and compliance with global regulations. The ideal candidate will have profound experience in Drug Safety & Pharmacovigilance and Risk Management in pharmaceutical company in both clinical and post-marketing.

Roles And Responsibilities

• Provide strategic Patient Safety input to drug development and post-marketing programs of the given product.
• Compile safety information for clinical overviews, post-marketing safety assessment, risk management plans, labeling justifications, CCSI development and written summaries of clinical safety of common technical documents.
• Undertake and prepare high-quality evaluation documents to describe safety findings in collaboration with external vendors (when applicable).
• Leads and reviews PV aggregate safety reports for assigned product(s) (e.g., DSUR, PBRER/PSUR), including safety database requests, working with the report's authors, and ensuring effective planning in accordance with the regulatory timelines.
• Responsible for preparation and maintenance of core safety information as used for Investigator's brochures and labeling.
• Lead the signal detection activities including safety surveillance activities, medical review and benefit-risk assessment of assigned product(s).
• Support the development of risk management strategies for investigational compounds.
• Address safety questions from Regulatory Authorities.
• Chair the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues.
• Provide leadership to support project discussions with governance boards, including interactions with Medical Safety Review Council and leads the safety strategy for regulatory communication.
• Provide regular updates on safety data trending, signaling and other safety related issues to the Medical Safety Review Council (MSRC) and recommend pharmacovigilance / risk management actions on behalf of the Medical Safety Team.
• Support PV audits and inspections by participating in audit readiness activities and serving as subject matter expert during regulatory inspections.
  
  

• A Medical degree with clinical experience[KM1] [YN2] is required.
• Must have 7+ years of profound experience in Drug Safety & Pharmacovigilance and Risk Management in pharmaceutical companies in both clinical and post-marketing. Experience in non-clinical is desirable.
• Experience in rare diseases and neurology preferred.
• Experience in signal detection with demonstrated experience in analysis, and interpretation of medical and scientific data.
• Experience in safety data analysis and writing product-related aggregate reports and safety assessments.
• Experience in the design, implementation, tracking and follow up of risk management plans.
• Experience in MedDRA coding and search strategies.
• Knowledge of regulations and guidance (EU, US and global).
• Direct experience in interacting with Health Authorities preferred.
• New product launch experience desired.
  
  

• Ability to apply clinical judgment to interpret case information.
• Ability to synthesize large amounts of medical data and draw medical conclusions.
• Excellent interpersonal and communication skills (both written and oral) required.
• Demonstrated ability to work effectively in a cross-functional team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as independently.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong knowledge of international regulatory requirements including ICH, European Pharmacovigilance legislation, FDA and CIOMS.
• Project management skills preferred.
  
  

• This is a full-time remote position with occasional in-person/face-to-face meetings.
• Flexible schedule with interactions across Israel, North America and Europe time zones.
• Occasional international travel is required