Arcellx
Director of Pharmacovigilance
Arcellx, Redwood City, California, United States, 94061
Who We Are
Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
Character : Committed to always doing what’s right.
Audacity : Willing to challenge convention and share candid feedback with others.
Determination : Curious and self-motivated. Always looking to improve and learn.
Collaboration : "No job is too small" mentality. Humble and willing to help others.
Originality : Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
The “Fine Print” – What You’ll Do
Advance and maintain safety governance oversight for all Arcellx products.
Provide strategic leadership for the function.
Oversee all PV-related activities performed by external vendors, ensuring appropriate documentation and governance frameworks are in place.
Lead development of departmental SOPs.
Collaborate with cross-functional partners, providing input and oversight for safety and PV.
Ensure the timely assessment and reporting of individual case safety reports (ICSRs) by the PV vendor.
Oversee aggregate reporting, management of benefit-risk profiles, signal detection and risk management and mitigation plans for Arcellx products.
Represent PV in audits with health authorities and development partners.
Skills and Experience We Look For
RN/BSN, MS, MPH, PharmD or equivalent degree.
8+ years of combined experience in biotech/pharma drug safety and pharmacovigilance, including at least 5 years in PV management roles.
Immuno-oncology therapeutic area experience or equivalent required.
Advanced working knowledge of safety & pharmacovigilance regulations and guidelines.
Experience with safety databases such as Argus or ARISg and MedDRA coding.
Strong vendor management, leadership, and communication skills.
Rewards at Arcellx
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The base salary range for this position is $250,000 - $280,000 per year. Where a candidate falls within that range is determined by factors such as years of experience and education. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to
www.arcellx.com
.
#J-18808-Ljbffr
Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California. At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us
Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values
Character : Committed to always doing what’s right.
Audacity : Willing to challenge convention and share candid feedback with others.
Determination : Curious and self-motivated. Always looking to improve and learn.
Collaboration : "No job is too small" mentality. Humble and willing to help others.
Originality : Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
The “Fine Print” – What You’ll Do
Advance and maintain safety governance oversight for all Arcellx products.
Provide strategic leadership for the function.
Oversee all PV-related activities performed by external vendors, ensuring appropriate documentation and governance frameworks are in place.
Lead development of departmental SOPs.
Collaborate with cross-functional partners, providing input and oversight for safety and PV.
Ensure the timely assessment and reporting of individual case safety reports (ICSRs) by the PV vendor.
Oversee aggregate reporting, management of benefit-risk profiles, signal detection and risk management and mitigation plans for Arcellx products.
Represent PV in audits with health authorities and development partners.
Skills and Experience We Look For
RN/BSN, MS, MPH, PharmD or equivalent degree.
8+ years of combined experience in biotech/pharma drug safety and pharmacovigilance, including at least 5 years in PV management roles.
Immuno-oncology therapeutic area experience or equivalent required.
Advanced working knowledge of safety & pharmacovigilance regulations and guidelines.
Experience with safety databases such as Argus or ARISg and MedDRA coding.
Strong vendor management, leadership, and communication skills.
Rewards at Arcellx
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
The base salary range for this position is $250,000 - $280,000 per year. Where a candidate falls within that range is determined by factors such as years of experience and education. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant. We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to
www.arcellx.com
.
#J-18808-Ljbffr