Agenus

Director, Medical Safety Evaluation, MD

Job Locations US-MA-Lexington
Job ID
2018-1347
Category
Regulatory

Overview

This is an outstanding opportunity for an experienced professional in drug development and medical safety evaluation in the biotech arena to join motivated and newly formed Regulatory Science & Pharmacovigilance (RSP) business unit aiming at brining regulatory innovation in drug development and commercialization.

 

The RSP aims to maximize opportunities for product approval, its safe use and further development by:

 

  • Leading global regulatory strategies that allow drug and CMC development efforts to achieve a faster regulatory approval, optimal product label and support commercial success
  • Delivering regulatory milestones and timely registration throughout the product lifecycle
  • Ensuring patient safety by early identification of safety signals, building robust PhV systems and preparing for post-marketing commitments
  • Proactively influencing and engaging with healthcare environment and regulatory policy framework to facilitating approval and market penetration

 

The Company is seeking an experienced physician with medical safety evaluation in oncology field with over 10+ years in the international pharmaceutical industry or hospital. Management experience of cross-functional team over 5 years is a prerequisite. The position is highly visible to internal and external stakeholders and requires political savvy and agility in building consensus and complying with applicable law and regulations.

 

The position reports to the Vice President of Regulatory Science & Pharmaco-vigilance business unit.

 

 

 

 

Responsibilities

 

 

  • Develop and maintain processes for drug safety surveillance and ensures safety of drug development activities in compliance with state and federal regulations and company standard operating procedures
  • Conduct evaluation and analysis and ensure timely reporting of adverse events in compliance with global safety regulations
  • Contribute to regulatory dossier preparation and FDA meetings in line with global regulatory strategy
  • Collaborate with internal and external partners (CRO, experts) and ensure adherence to project timelines

Qualifications

 

 

  • MD degree with 10+ years experience in drug safety surveillance during development and LCM for Oncology or Immunology products
  • Experience in interaction with FDA and development of REMs to support regulatory approvals
  • Knowledge of ICH, FDA and EMA guidelines relative to Pharmacovigilance
  • Experience with development of strategic priorities, processes and operating procedures to ensure compliance with appropriate regulations and Pharmacovigilance quality standards

 

Core Competencies

 

  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Attention to details and sense of urgency to ensure timely reporting of SAEs and follow up to health authorities in compliance with regulations
  • Ability to influence and lead cross-functional team toward successful negotiation with agency
  • Ability to influence and interact effectively with internal and external customers
  • Ability to work effectively across functions in drug development and commercial organizations
  • Team player with good interpersonal skills
  • Strong oral and written communication skills
  • Good presentation, organization and planning skills
  • Able to undertake significant travel (approx. 30% a year)
  • Fluency in English, written and spoken - knowledge of other languages valuable

 

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