Director, Safety Science

About Allogene:

Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.

At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

About the role:

Allogene Therapeutics is seeking a highly motivated Director, Safety Science in the Drug Safety group to support the serves as the lead safety expert, accountable for the global safety strategy and overall safety profile of an allogenic CAR T therapy in phase II development. This includes all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. You will provide scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, ongoing clinical studies, literature and other information sources. You will focus on the pro-active identification, evaluation, and risk management of safety risks to patients.

The position will report to the Vice President of Pharmacovigilance, and will interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. You will need to be self-motivated, have strong communication and teamwork skills along with a robust ability to work independently, problem solve, manage work priorities, build collaborative team relationships at all levels, and remain flexible to the needs of the teams and projects. You will need to be someone who can roll up their sleeves and get the job done. The role will be located at 210 E. Grand Ave, South San Francisco, CA 94080 and may be remote up to 2 days per week. The ideal candidate is an individual who is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges.

We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.

Responsibilities include, but are not limited to:

• Manage all pre- and post-marketing safety surveillance activities for a CD19 allogenic CAR T therapy in phase II development, in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP)
• Develop global safety strategy ensuring review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for Allogenic CAR T therapy in collaboration with essential stakeholders
• Collaborate with other functional areas, including but not limited to Biostatistics, Clinical, Translational Sciences, Research and Regulatory Affairs to identify, evaluate, understand and risk manage safety signals
• Prepare for and present at Pharmacovigilance Committee meetings, such as Safety Review Board and meetings with clinical development team
• Provide safety science support and input for clinical development programs
• Author relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans, study reports and other clinical study-related documents to ensure alignment with the safety strategy and risk communication
• Review and edit aggregate reports e.g. (DSUR) in collaboration with the aggregate report writers
• Participate in the development of safety-related data collection standards for clinical studies to ensure consistency in safety data collection
• Collaborate on the strategy and authoring of health authority and other safety related query responses
• Collaborate in the planning for and creation of an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection
• Medical review of individual case safety reports (ICSRs) in a timely manner to ensure on time submission to regulatory authority
• Demonstrate knowledge and ensure compliance with current and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH)
• Work collaborative with PV VP and Safety operations team to help build the PV department
• Other duties as assigned

Position Requirements & Experience:

• MD or Pharm D with a minimum of 3 years’ of clinical practice and 3+ years’ industry experience
• Experience working on oncology trials, ideally cellular therapies
• Experience supporting Phase II studies
• Expertise in US and international regulations governing drug safety
• Experience in signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials
• Excellent interpersonal, team management, and leadership skills
• Excellent communication skills, both written and verbal
• Expertise in PowerPoint and Excel
• Knowledge of Pharmaceutical dictionaries and understanding of MedDRA coding
• Experience using analytics tools (Spotfire, Tableau, etc.)
• Ability to analyze, interpret, and summarize complex clinical and medical literature data
• Experience in the principles and techniques of data analysis, proficient in data analysis and data presentation; interpretation and clinical relevance
• Working knowledge of industry standard safety databases (ARGUS and ARISg), Regulatory databases, and other electronic data capture systems
• Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance
• Ability to effectively work in a fast-paced, biotech environment, while dealing with ambiguity
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Ability to work independently and as part of a team
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $200,000 to $240,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers

#LI-MT1