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 area for this hybrid on-site role.The Position
Reporting to the Head of Bioassay Development and Operations, the Bioassay Development Lead (BDL)
will work in partnership with the Gates-MRI development functions, CROs, academic collaborators and consultants to implement and drive clinical biospecimen strategies for life saving vaccines and therapeutics targeting those most in need living in low- and middle-income countries.
Responsibilities include the following:
- Scientific leadership of bioassay strategies including vaccine immunogenicity and neutralization, biomarkers, regulated bioanalysis (PK/ADA), and diagnostics
- Oversee method development and fit-for-purpose validation at CROs to meet the program team needs and authorize methods for in-study use
- Collaborate with the Exploratory Biomarker Leads, Discovery staff and others on feasibility to transfer research assays, identify additional assay needs for clinical development, and propose opportunities to include additional preclinical experiments to facilitate clinical biomarker programs
- Collaborate with Bioassay Operations Leads, Clinical Trial Leads, and project teams to develop bioassay outsourcing strategies
- Work with Bioassay Operations Leads, CRO partners, academic collaborators, and consultants to develop bioassay timelines, budgets, and milestones
- Proactively identify clinical trial implementation challenges and risks relating to biospecimen collection, shipment, storage, and analysis and propose plans to mitigate those risks
- Work with Bioassay Operations Lead, Procurement, and Legal to develop SOWs, MSAs, NDAs, and manage contracts
- Represent the Bioassay Team on Clinical Development Teams, relevant project subteams, and at external meetings
- Collaborate with Bioassay Operation Leads to oversee contractors and vendors
- Be able to travel, including internationally, up to 10%
The successful candidate will be an innovative and collaborative individual who thrives in a "get it done" type of environment with a strong track record of hands-on experience in a regulated environment supporting the outsourcing of bioassays with the following mix of personal and professional characteristics:
- PhD, MS or BS in an appropriate scientific discipline
- 10+ years in the CRO/biopharmaceutical industry with direct experience in vaccine or therapeutic immunogenicity and functional neutralization assays required
- Experience in overseeing other bioassay platforms and sample types preferred, including regulated bioanalysis of PK/ADA for therapeutics, biomarkers, and diagnostics
- Strong understanding of clinical trial conduct and regulatory interactions
- Flexible mindset to identify alternate approaches in resource-constrained settings
- Experience supporting clinical trials in low- and middle-income countries a plus
- Must be able to work both independently and in a matrixed team environment
- Ability to work on several projects simultaneously with minimal supervision
- Ability to work well with a wide range of stakeholders to build strong partnerships and alliances inside and outside the organization
- Clear and effective communication skills with strong interpersonal skills
- Strong ability to prioritize and operate with a sense of urgency
- Demonstrated passion for the Gates MRI's values with a commitment to deliver results against our mission
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.Accommodations
If you require assistance due to a disability in the application or recruitment process, please submit a request to [ Email address blocked ] - Click here to apply to Bioassay Development Lead
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.
- Clinical Trials
- Clinical Works
- Diagnostic Skills