Director of Pharmacovigilance

Posted 3 Days Ago
Be an Early Applicant
Redwood City, CA
Senior level
Biotech
The Role
The Director of Pharmacovigilance at Arcellx is responsible for overseeing safety governance and management for all products, leading departmental SOP development, and ensuring timely assessment of individual case safety reports. This role includes strategic leadership of pharmacovigilance functions and collaboration with cross-functional teams while representing PV in audits with health authorities.
Summary Generated by Built In

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.

 #LI-Onsite

Top Skills

Argus
Arisg
Bsn
Meddra
Mph
Ms
Pharmd
Rn
The Company
HQ: Gaithersburg, MD
93 Employees
On-site Workplace

What We Do

We are a clinical-stage biotechnology company reimagining cell therapy through the development of innovative immunotherapies.

Similar Jobs

Redwood City, CA, USA
300 Employees
Easy Apply
3 Locations
600 Employees

The Aerospace Corporation Logo The Aerospace Corporation

Missile Warning Ground Segment Leader

Aerospace • Artificial Intelligence • Cloud • Machine Learning • Cybersecurity • Defense
Hybrid
El Segundo, CA, USA
4600 Employees
156K-234K Annually

Rula Logo Rula

Director of Strategy & Operations (Remote)

Healthtech • Other • Social Impact • Software • Telehealth
Remote
Los Angeles, CA, USA
450 Employees

Similar Companies Hiring

Pfizer Thumbnail
Pharmaceutical • Natural Language Processing • Machine Learning • Healthtech • Biotech • Artificial Intelligence
New York, NY
121990 Employees
Takeda Thumbnail
Software • Pharmaceutical • Manufacturing • Healthtech • Biotech • Analytics
Cambridge, MA
50000 Employees
Asimov Thumbnail
Machine Learning • Design • Biotech • Artificial Intelligence
Boston, MA
95 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account