Full-Time

Director of Pharmacovigilance

Confirmed live in the last 24 hours

Arcellx

Arcellx

51-200 employees

Develops immunotherapies for cell therapy

Biotechnology
Healthcare

Compensation Overview

$250k - $280kAnnually

+ Bonus + Equity Grant

Senior

San Carlos, CA, USA

Relocation assistance offered if required.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • 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.
Responsibilities
  • 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.

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products focus on advanced techniques that enhance the effectiveness of treatments. The company collaborates with healthcare providers and research institutions to bring these therapies to patients. Unlike many competitors, Arcellx emphasizes proprietary products and partnerships to drive their research and development efforts. The goal is to meet unmet medical needs by providing safe and effective treatment options through their innovative approach to cell therapy.

Company Stage

IPO

Total Funding

$194.5M

Headquarters

Gaithersburg, Maryland

Founded

2014

Growth & Insights
Headcount

6 month growth

18%

1 year growth

24%

2 year growth

72%
Simplify Jobs

Simplify's Take

What believers are saying

  • The Phase 3 iMMagine-3 trial for anito-cel could significantly boost Arcellx's market position if successful.
  • Recent robust long-term responses from the Phase 1 expansion trial of anito-cel indicate promising efficacy and safety, potentially leading to FDA approval.
  • The $285M equity investment and upfront cash from Kite provide substantial financial backing for Arcellx's ongoing and future projects.

What critics are saying

  • The competitive landscape for CAR T therapies is intense, with established players like Abecma and Carvykti posing significant challenges.
  • Regulatory hurdles, such as the recent FDA partial hold, could delay product development and market entry.

What makes Arcellx unique

  • Arcellx's anitocabtagene autoleucel (anito-cel) is the first BCMA CAR T therapy for multiple myeloma utilizing a novel D-Domain binder, setting it apart from existing treatments.
  • The company's strategic partnership with Kite, a Gilead Company, enhances its research capabilities and market reach, distinguishing it from smaller biotech firms.
  • Arcellx's focus on innovative immunotherapies for cancer and other incurable diseases positions it uniquely in the biotech landscape.

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