Head of Pharmacovigilance

Location
Gaithersburg, MD
Posted
Jun 02, 2021
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies.  The company is in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development.  Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

 

Primary Objective:

The Head of Pharmacovigilance is responsible for the PV of all Arcellx products throughout the product lifecycle. Reporting to the Chief Medical Officer, the incumbent is accountable for the development, implementation, and maintenance of corporate policies, procedures and practices ensuring the safety of our products in development and post marketing. The Head of Pharmacovigilance ensures medical input to the monitoring and assessment of the safety profile for all products.

Main Accountabilities:

  •  Advance and maintain the safety governance oversight for all Arcellx products
  • Build and manage a high-growth pharmacovigilance team, including recruitment, training, assessment, monitoring and development. Communicate company/departmental information effectively to team.
  • Provide global strategic leadership by setting clear expectations & providing hands-on leadership for PV, promoting collaboration and team cohesiveness.
  • Oversee all PV-related activities performed by external suppliers/consultant, ensuring appropriate documentation and governance frameworks are in place
  • Interact with internal and external staff to develop programs and processes to meet regulatory reporting requirements.
  • Lead process improvement within global pharmacovigilance – including technology assessment and implementation.
  • Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including review of clinical study protocols, development plans, INDs/CTAs and serious adverse event handling and all other PV issues, as appropriate.
  • Oversee aggregate reporting, management of risk-benefit profiles, signal detection and risk management and mitigation plans for clinical and post-marketing compounds.
  • Directly oversees the PV staff and operations (including external resources) globally to ensure high quality case processing and aggregate reporting consistent with quality performance metrics.
  • Successfully plan and forecast for global resources and PV budget and partner with other groups on resource needs (e.g., medical organization for writing and statistical staffing; medical affairs for epidemiology project needs).
  • Implement global process standardization and improvement.
  • Provide safety expertise to other departments and functions.
  • Ensure PV staff are able to meet safety monitoring needs based on regulatory requirements and company standards for pharmacovigilance and are audit-ready.
  • Represent PV in audits with health authorities and development partners.
  • Oversee development of training modules and provide training in Pharmacovigilance across the Company.
  • Oversee aggregate medical review and signal detection/analysis activities for the  product portfolio
  • Ensure compliance of operations with governing regulatory requirements
  • It is imperative that Arcellx employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

Preferred Qualifications:

  • MD, degree or equivalent
  • At least 12 years of pharmaceutical industry experience, including at least 5 years in pharmacovigilance management roles
  • 2 – 3 years of clinical practice experience preferred

 

Competencies:

• Commitment to ethical scientific investigations and rigorous experimental methods.
• Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
• Sense of urgency in performance of duties.
• Interpersonal skills that promote a collaborative and productive lab environment.
• Effective and efficient written and oral communication skills.

 

 

Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.