• Job Description

  Req#: B018366

  We are focused on results. Those that can be measured. And those measured in ways beyond numbers.

  We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.

  -Bill and Melinda Gates

  The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biotech dedicated to accelerating the product development timeline for diseases that disproportionately affect the world’s poorest populations, including malaria, tuberculosis, and diarrheal diseases—diseases that combined cause five deaths every minute- and a range of challenges in maternal and newborn health. Headquartered in Cambridge, MA and led by CEO Emilio Emini, Ph.D. our focus is on advancing novel drug and vaccine candidates against the aforementioned diseases from the laboratory into human studies and beyond. At the Gates MRI, we work across multiple interventions and disease areas to increase the identification, selection, and optimization of novel drug and vaccine candidates, with the intention to develop viable candidates through late-stage development and registration both in house and with partners across the global health ecosystem. We will seek to publish our learnings, so that they will be available to all research and development communities through our commitment to open access.

  To enable a fast-to-decision mindset, the institute operates using small teams and a flat structure with the understanding that it is essential to break out of silos and embrace unconventional approaches across modalities. The five core mantras that permeate across the organization and drive progress at every level are:

  • Urgency : Execute with excellence to maximize impact.

  • Collaboration : Establish empowered teams to drive our bottom line: lives saved.
  • Innovation : Build on the known, uncover the new, achieve the unprecedented.
  • Rigor: Drive the science, focus on the details, and execute with the highest quality.
  • Courage : Dare to confront the world’s most significant global health challenges.

  Though the Institute is a diverse group of passionate change-makers, creative fixers and relentless advocates, these five core values will be universally adopted by all who join it and strive to improve the health and wellness of the world’s most vulnerable populations.

  The Gates MRI offers flexible work arrangements for local candidates (50% on site) and a competitive relocation package for those looking to move to the Cambridge, MA.

  THE POSITION

  Reporting to the Pharmacovigilance Operational Leader (or Chief Medical Officer-depending on level), the Pharmacovigilance Medical Lead(er) will be responsible for providing scientific and medical support to Clinical Development to ensure participant safety and the successful operational execution of clinical trials across our portfolio at the Gates MRI. The successful candidate will be an experienced hands-on leader that will serve as a medical lead and a subject matter pharmacovigilance expert.

  The Pharmacovigilance Medical Lead(er) will be responsible to ensure safety oversight for clinical studies in all phases is conducted in accordance with the protocol, in compliance with ethical and regulatory requirements, within timelines and budget and in accordance with company SOPs, GCP, and ICH guidelines.

  The Pharmacovigilance Medical Lead(er) may have line management responsibilities for both Gates MRI FTEs and temporary staff, including the development, training, and management of assigned pharmacovigilance team members, and will be a mentor for pharmacovigilance and clinical development staff.

  In addition, the Pharmacovigilance Medical Lead(er) will work collaboratively with other leaders within the Gates MRI organization to improve the effectiveness and efficiency of processes and procedures supporting clinical trials.

  SUMMARY OF RESPONSIBILITIES

  • Provide pharmacovigilance medical support for the Clinical Development portfolio
  • Provide medical review of clinical ICSRs and clinical study coding
  • Collaborate with cross functional team on regulatory submission of safety documents such as DSURs, 6 monthly SAHPRA reports, and other required aggregate study reports to support regulatory compliance in the study regions
  • Provide company approval for external safety reporting to health authorities, investigators, and partners as required
  • Collaborate with global partnerships (academic, nonprofit, large pharma, and biotech companies) in complex combination product development
  • Contribute to study protocols, investigator brochures, safety management and expedited reporting plans, clinical study reports with associated tables, listings and figures, and other study related documents from a clinical safety perspective
  • Support Safety Governance and signal detection, contributing to scheduled and ad hoc SRC/ESC meetings by reviewing and synthesizing clinical safety data with study team for committee members

  QUALIFICATIONS

  • Medical degree (MD/DO) required, with clinical medical experience preferred
  • Pharmaceutical industry experience with at least 10 years of pharmacovigilance experience, including developmental product pharmacovigilance required
  • Pre-clinical, Phase I to Ph III experience with a particular focus on Phase III (large scale global clinical trials) required
  • Global PV experience required. Previous experience with developing countries and target populations – e.g., Africa, South East Asia, a plus
  • Experience in Infectious Diseases or Vaccines experience a plus
  • Detailed knowledge of GCP, ICH Guidelines and US FDA regulations
  • Experience working in highly matrixed organization
  • Clear and effective communication & diplomacy skills
  • Excellent leadership and interpersonal skills; ability to collaborate across disciplines
  • Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission.
  • Local and international Travel ~20%

  #LI-TH1

  Hiring Requirements

  As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.

  Depending upon your work location, we may require proof of full vaccination against COVID-19 and any recommended booster doses. All employees based in the United States are to provide proof of full vaccination upon hire and any recommended boosters, subject to applicable laws.

  Candidate Accommodations

  If you require assistance due to a disability in the application or recruitment process, please submit a request here.

  Inclusion Statement

  We are dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.

  All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.

• About the company

  The Bill & Melinda Gates Medical Research Institute is a non-profit organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns.

Notice