Vice President, Head of Safety and Pharmacovigilance

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

We currently have ongoing trials in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) with our lead clinical candidate, cemacabtagene ansegedleucel (cema-cel), an off-the-shelf, allogeneic anti-CD19 CAR T cell product candidate. The focal point of this program is the ALPHA3 trial. ALPHA3 is a registrational, randomized trial of cema-cel in patients who are at very high risk of disease relapse following front-line treatment for large B-cell lymphoma (LBCL). The trial, which is currently enrolling and is expected to support a biologics licensing application (BLA) submission in 2027, is designed to test cema-cel vs the current standard of care, close clinical observation following completion of therapy, as consolidation therapy in patients who achieve a remission but remain positive for circulating tumor DNA (ctDNA) measurable by an ultrasensitive minimal residual disease (MRD) test. An additional phase 1 program with another CAR T product, ALLO-316, which targets CD70, is ongoing in patients with advanced or metastatic, relapsed or treatment-refractory renal cell carcinoma.

Early in 2024, we also announced our intention to study the first dual targeting, anti-CD19/anti-CD70 CAR T product in patients with treatment-resistant autoimmune disorders. This patient- and rheumatologist-focused product, ALLO-329, was designed specifically for use in autoimmunity. As an off-the-shelf therapy with the potential to reduce or even eliminate the requirement of chemotherapy-based conditioning regimens, ALLO-329 is poised to build on the early proof-of-concept established by autologous CAR T products in autoimmunity and potentially revolutionize the care of these patients.

As the leader in allogenic cell therapy, Allogene is pushing scientific boundaries across multiple indications in cancer and autoimmune disease and has a sole, unifying focus on bringing off-the-shelf cell therapy to millions of patients worldwide.

About the role:

Reporting directly to the Head of R&D/CMO, this leader will work across functions including Clinical Development, Clinical Operations, Regulatory Affairs, Translational Science, Quality and others in supporting our efforts in this exciting new area of cancer immunotherapy. Remote candidates will be considered according to fitness for the role; frequency of on-site presence at our headquarters in South San Francisco, CA will be negotiated. 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:

• Leadership of the safety team, provide necessary training and ongoing coaching and recognition of direct staff, including performing annual performance reviews
• Ensure the performance of employees is proactively managed and they are coached, trained and developed in order to maximize their contribution
• It is expected that the Head of PV will serve as the in-house drug safety and pharmacovigilance subject matter expert for product candidates
• Oversight of clinical trial safety including safety monitoring plan and data analysis
• Assess emerging safety data, ensure appropriate risk communication, and development of risk management/minimization strategies
• Cross-functional leadership in in managing interactions with Health Agencies around product candidate safety
• Leadership of Safety Review Committee meetings and participation in DSMB meetings as appropriate
• Pharmacovigilance strategy and implementation
• Oversight of authorship of aggregate safety reports, including DSURs, Health Authority SAE reporting, Investigators’ Brochures and other safety aspects of regulatory filings
• Oversight of safety vendors
• Identification and communication around opportunities for change and alignment and leadership toward change when necessary
• Influence and/or develop broad-based programs and initiatives to meet executive level vision and mission
• Collaborate with functional leaders to set strategy and shared objectives
• Accomplish results through the management of a team of managers, professional employees and/or other leaders as well as individual contributors
• Represent Allogene as the Safety representative at meetings with regulatory authorities and third parties such as licensing or co-development partners, consultants, etc.
• Other duties as assigned

Position Requirements & Experience:

• MD or equivalent degree; completion of residency with industry experience in safety and pharmacovigilance; oncology and/or autoimmune development experience required; cell therapy experience is additionally desirable
• Global experience in clinical trial as well as post-marketing setting (oncology/cell therapy experience highly preferred but not required)
• Experience with global regulatory filings
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the 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
• Ability to communicate with internal and external physicians to evaluate specific safety events
• Strong knowledge and understanding of US, EU and Asian pharmacovigilance regulatory requirements and general regulatory expectations
• Ability to evaluate CROs and other vendors that may assist Allogene in fulfilling safety oversight and reporting obligations
• 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 $320,000 to $380,000. 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.

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Last updated on Sep 26, 2024