Senior Director, Clinical Safety Science - ALX Oncology Inc.

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

Under the general direction of the Head of Pharmacovigilance/Drug Safety, the Senior Director, Clinical Safety Science is responsible for overall clinical risk management and safety surveillance of assigned investigational and marketed drugs. The individual in this role will provide program-specific scientific direction and guidance regarding the implementation of an asset safety profile for a matrix team who are typically assigned to support the program. They will lead their team members and work with contract employees to define long term safety related objectives for all ALX programs, acting as the main point of contact for safety for wider cross-functional leads; being responsible for the high-level safety program design/plan; guiding the scientific approach to the acquisition, monitoring, analysis/evaluation and communication/reporting of program-specific safety information.

The individual will articulate the overall design and the requirements of the defined safety strategy, in the context of development programs and medical value narratives. This individual is accountable for ensuring that program-specific safety communications and patient risk management approaches are implemented and can be demonstrated to be effective in achieving their defined aims. This position reports to the Head of Pharmacovigilance/Drug Safety and will oversee teams in safety related and benefit-risk decision making activities across ALX programs. The individual will effectively engage cross-functional leads as the safety point of contact.

Key Responsibilities

• Leads proactive pharmacovigilance signal detection and risk management planning for designated ALX Oncology products, including signal identification, evaluation, interpretation of safety signals and trends and communication (written and verbal) of safety risks.
• Collaborates with interdepartmental stakeholders from Clinical Development, Regulatory Affairs, Biostatistics and Data Management, as well as with Contract Research Organizations (CROs), business partners to manage and evaluate safety signals across ALX products.
• Support product development activities via internal and contracted Risk Management/Safety Teams and Product Development Teams and other related sub- team participation, including participation in project teams relevant to the development of new compounds and the further study of future marketed compounds.
• Work closely with a cross-functional group of experts in epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation.
• Lead and/or participates in the preparation and review of safety risk section(s) of Investigator brochures (IBs), protocols, informed consent/assent forms, clinical study reports/synopses, Integrated Summary of Safety)/Common Technical Document (CTD) submissions and other documents as needed; ensure risk-reduction strategies are implemented timely and appropriately in relevant documents.
• Lead and/or participate in preparation of aggregate safety reports (e.g.; DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans (RMPs) under the guidance of the Head of Pharmacovigilance/Drug Safety.
• Perform medical review of ICSR
• Responsible for all aspects of safety data evaluation, including assessing safety from multiple sources, e.g. clinical trials, literature and post-approval use and ensuring completeness of safety information in worldwide package reports.
• Support risk management activities such as contributing to recommendations for pharmacovigilance actions and making recommendations for labeling.
• Ensure the safety sections of company product reports are medically and scientifically appropriate.
• Analyze and summarize the findings from available safety data to support decisions.
• Supervise the activities of others in the execution of safety data analysis and medical writing as needed.
• Responsible for the development of future worldwide post-market risk management plans, pharmacovigilance strategies and risk minimizations activities as warranted.

   Education, Skills and Experience

• MD degree or equivalent (e.g., DO, MB), PharmD, or PhD with knowledge in malignant hematology and oncology.
• An equivalent combination of education and experience may be considered.
• Preferably have experience in clinical medical practice and will typically possess at least 8 years of experience in clinical drug safety-related role.
• Principled and strong written and verbal communications and analytical skills.
• Drug safety, pharmacovigilance and/or risk management industry experience in both the investigational and post-approval environments.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies.
• Experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI.
• Proficiency in Microsoft Office; Argus Safety Database experience is a plus.
• Efficient in time management and multi-tasking.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision.

Salary: $260,000-$290,000

$325,000-$350,000 for MD candidates  

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.