Senior Director, Risk Management, DSPV

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell–mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary:

The Senior Director, Risk Management, Drug Safety & Pharmacovigilance (DSPV) will report to the Vice President, Drug Safety & Pharmacovigilance and will be responsible for our Risk Management strategy and Benefit Risk Office at Vera which strives for excellence and the creation of a best practice framework. As a Risk Management Lead, you will be empowered to work cross-functionally with colleagues to establish and manage the processes for Risk Management, benefit risk, RMPs, additional Risk Minimization Measures and REMS programs and other Benefit Risk deliverables. The overall goal of the Risk Management Lead is to optimize the proactive impact made by the PV department at Vera while maximizing patient safety and minimizing/preventing patient risk.

Responsibilities:

• Serves as Project manager of the PV Risk Management System to oversee, evaluate, characterize, strategize, implement, assess and track vera’s PV Risk Management obligations, commitments and proposed minimization measures to ensure patient safety is at the forefront of DSPV.
• Provide recommendations and guidance through subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide.
• Provide recommendations and guidance through subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment documentation.
• Work closely with cross-functional teams (e.g. Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, and Biostats) to ensure alignment of Vera’s global position for the PV risk management processes.
• Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.
• Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations.
• Remain up to date and well informed on all Regulatory intelligence as it relates to risk management and relay this to the Project team and the PV medical safety science team.
• Aide in the development and review risk minimization documents such as Developmental RMPs, RMPs, risk minimization measures and Risk Evaluation and Mitigation Strategy (REMS).
• Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments.
• Provide guidance on incorporation of the patient’s perspective into benefit-risk activities (e.g. Real-World Evidence studies with Medical Affairs).
• Collaborate with PV Physician Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross-functional teams on benefit risk assessment strategy.
• Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program.
• Provide guidance and drive the creation of tracking risk management commitments including utilization of a tracking spread sheet or platform and improvement assessments
• Monitor and report risk management metrics to ensure compliance.
• Provide centralized support, training, and leadership for safety and cross-functional members who work on risk management plans and risk minimization activities.
• Support inspections and audit activities internally and externally with regards to risk management processes.
• Perform other duties as defined in standard operation procedures or requested by supervisor.
• Work with PV Physician and PV Scientists to aide in the proper characterization and classification of Risk from initial signal to evaluation, validation, implementation in study documents, protocols, IBs, ICFs, and RMPs.
• Work with VP of DSPV, PV Physicians and PV Scientists on any Regulatory Submission/filing for BLA, SBLA, MAA, etc. to be sure that risks are reflected properly and carried through to support filing activities.
• Oversee risk components of Aggregate reports like DSUR, PBRER etc.
• Work with PV Physicians and PV Scientist in risk presentations at safety Governance meetings (MSRB & MSRC) to ensure proper communication of risk is achieved and proper course of action is followed.
• Manage and oversee any outsourced RMP related activities to external vendors.

Qualifications:

• PhD/Pharmacist/ PharmD/DO/MD with 12+ years of experience.
• Minimum 5-10 years in PV/safety OR clinical development preferred.
• Minimum 5-10 years of pharmaceutical industry/drug development experience.
• Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures, and/or REMS programs preferred.
• Strong track record of scientific and analytical thinking.
• Experience presenting at meetings is desirable.
• Work with integrity and work proactively in a fast-moving environment.
• Good Critical thinking skills. Ability to use good analytical/judgment skills to understand, analyze, and communicate.
• Project Management Skills with ability to manage both time and priority constraints and to manage multiple priorities simultaneously.
• Attention to detail, computer literacy, knowledge of safety databases.
• Good working knowledge of all the functions within PV from PV operations onto medical safety science and all processes in between.

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