Toxicology Scientific Lead

Job Title: Toxicology Scientific Lead

Job Location: Cambridge, MA, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

“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 Gates and Melinda French-Gates
  
  
  

The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute. Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration. The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions. The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.

The Institute is based on five core “mantras” that are embedded within the organization and its people:

• 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 are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.

As a wholly owned subsidiary and separate legal entity of the Bill & Melinda Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.

The Institute is currently composed of 160 employees and leverages dedicated vendor partnerships and consultant staff to assure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.

A competitive relocation package for those looking to move to the Cambridge, MA area is available though remote work may be available for those from currently approved states.

THE POSITION

Reporting to the head of Nonclinical Development, the Toxicology Scientific Lead will be required to have a flexible mindset and broad capabilities to support programs across our Global Health Portfolio in a dynamic biotech-like environment. The position will require the ability to multi-task and manage diverse responsibilities with minimal supervision. As the Nonclinical representative on appropriate Product Development Teams (PDT), you will communicate nonclinical strategies and issues/mitigation plans to teams and management and execute with a with a high level of autonomy and independence while effectively managing function/cross functional relationships. The position requires comfort with ambiguity in a dynamic environment, and the ability to succeed in a matrixed environment

Key Responsibilities

• Represent nonclinical safety with a high level of independence in multidisciplinary development teams
• Provide scientific and technical oversight for nonclinical studies conducted at contract labs in support of programs for which you have primary responsibility. This will include input on study designs, management of any issues, and effective communication with study monitor/director to ensure successful study execution and reporting.
• Develop and implement nonclinical plans that are aligned with clinical development strategies to meet regulatory requirements.
• Apply your drug development expertise to effectively communicate nonclinical information (strategies, study outcomes, issues, risks & mitigation, regulatory responses) to teams, external collaborators, and regulatory authorities, as appropriate.
• Collaborate with study monitor/director to generate high quality integrated nonclinical reports for inclusion in regulatory submissions
• Have in-depth and up to date understanding of key regulatory guidelines to support drug development
• Accountable for authoring nonclinical contributions to global regulatory submissions and responses to regulatory authorities.
• Lead resolution of any emerging nonclinical safety issues for your programs in collaboration with other functions or external collaborators, as appropriate.
• Develop hypotheses and propose mechanistic approaches to understand and mitigate issues that enable decision making
• Provide subject matter expertise to Gates MRI collaborators, as appropriate.
• Contribute to due diligence activities and other internal Gates MRI documents required for in-licensing of potential assets.
• Build effective internal and external collaborations through effective communication and relationship building
  
  
  

Qualifications

The successful candidate will have

• A doctoral degree (PhD, DVM, or equivalent) with a focus in toxicology, pharmacology, or related field and a minimum of 8-12 years of experience in pharmaceutical/biotech is required
• Toxicology Board Certification is required
• Experience as a project representative on drug development teams is required
• Experience in design, reporting, and interpreting exploratory or GLP safety studies is required
• Experience conducting or monitoring GLP safety studies is preferred
• Prior experience authoring regulatory submissions is required
• A broad understanding of the drug discovery and development process is required
• Drug development experience in any of small molecules, large molecules, vaccines, or other modalities is required
• Ability to integrate data from multiple sources and across disciplines to form risk assessment for a drug candidate is required
• Strong interpersonal skills, and excellent verbal and technical writing skills is required
  
  
  

In recognition of high-wage market differences such as the Cambridge, MA area where this position is located, the salary range for this role is $340,000 to $380,000 USD. Candidates hired in areas not considered local (Seattle, WA or Cambridge, MA) will be subject to a lower range. As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate’s job-related skills, experience, and expertise, as evaluated during the interview process.

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Hiring Requirements

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

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.

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