Assistant Dean of Students Residential

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.

Our tenacious, passionate employees’ challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

The Medical Director is responsible for safety strategy and major safety deliverables to support developmental and/or marketed programs, including both early and late-stage development, as assigned. He/she is accountable for safety and risk management activities and will manage cross‑functional assessment of benefit‑risk profile and communication of safety information. The individual will be an integral part of a group of safety staff and other professionals within Akebia and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners.

He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk‑management practices.

• Analyzes, reviews, and interprets clinical and post‑marketing safety data
• Lead, oversee and perform medical review of ICs and other drug safety information from various sources
• In collaboration with other functions, conducts signaling and safety surveillance process, including the identification, prompt assessment of safety observations, emergent safety concerns and new safety signals, and communication of confirmed safety signals
• Contributes and delivers key messages to the aggregate safety reports including development safety update reports, periodic benefit risk evaluation reports, and provide medical input and be able to author new or existing safety documents to ensure compliance with relevant regulatory requirements
• Provides medical safety expertise and strategy to author and review appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, CCSI and other labeling documents, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, RSI, PASS, RMPs, REMS, RTDs, PASS, INDs, NDAs, BLAs, and CTAs)
• Provides medical safety and Pharmacovigilance expertise in-house and by consultation with outside vendors for all development programs
• Contributes to the development of Standard Operating Procedures, Working Instructions, and other guidance documents
• Contributes to safety and pharmacovigilance training programs
• May provide safety training to internal staff and at investigator meetings
• Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
• Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services
• Training and mentoring of Pharmacovigilance Physicians and Safety Scientists
• Demonstrates knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, FDA, PMDA, EMA, ICH, etc.)

• 6+ years’ experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
• Medical Doctor (MD) or internationally recognized equivalent MD

• Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• Proficiency with medical review of ICs, including coding and use of SMQs, expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements
• At least 3 years of experience with authoring and reviewing aggregate reporting, safety surveillance, signal management and/or risk management.
• Experience with safety data collection and interpretation originating from clinical trials…