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What if you could join a rapidly growing company and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way?
What this position is all about: The Contract Toxicologist will be critical in executing the preclinical toxicology effort at Cellarity. The successful candidate will work cross-functionally to execute studies to advance drug candidates from discovery into the clinic, with a particular focus on exploratory, pilot, and pivotal studies. Additionally, they will be responsible for collaboration, communication, and alignment within the company and regulatory bodies. This is a 6-9 month contract position and will be based out of our Somerville, MA location.
What you would be responsible for:
- Execute on our toxicology efforts to support our preclinical programs.
- Ability to communicate and execute studies with CRO organization overseas.
- Provide toxicology expertise and strategic guidance to cross-functional project teams and senior management, including toxicology study results and potential impact of toxicology findings on programs.
- Serve as a member of program teams and collaborate with internal and external research partners including preclinical pharmacology, DMPK, and translational sciences to advance drug candidates from discovery to the clinic.
- Provide internal expertise to understand the mechanisms of toxicity, propose solutions for mitigation and back-up strategies.
- Design and direct nonclinical safety studies, including the evaluation and interpretation of safety pharmacology, toxicology, and toxicokinetic information.
- Develop optimal CRO network for toxicology studies, build and maintain effective vendor relationships.
- Serve as study monitor and sponsor representative for outsourced studies.
- Draft, review, and provide feedback on study protocols, reports, and other documentation as needed.
- Represent Cellarity in Regulatory Agency interactions for toxicology-related issues.
What experiences will you need:
- DVM or PhD in a relevant field (Toxicology, Pharmacology) with at least 5+ years of post-graduate drug development experience.
- Experience in developing and overseeing toxicology programs to support early and later stage drug development.
- Ability to oversee and advance development candidates in multiple programs simultaneously.
- Knowledge of relevant ICH & FDA guidance and regulations that are relevant for the strategic planning and conduct of safety studies to support first-in-human (FIH) testing.
- Demonstrated ability to apply critical thinking to solve complex problems to craft customized preclinical strategies for small molecule discovery programs.
- Experience in authoring of preclinical safety section in regulatory filings such as INDs/CTAs.
- Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation.
- Ability to oversee CRO interface, as appropriate, to deliver high quality, cost-effective, and timely safety assessment.
- Outstanding interpersonal skills and oral and written communication skills.
- Ability and experience in managing a team in a different time zone.
What sets you apart:
- Board certification in toxicology is highly desirable.
What it’s like to work at Cellarity
At Cellarity, we
- Push Boundaries: We create a legacy with breakthrough science in service of patients.
- Inject Energy: We build strengths from different perspectives and tell it like it is
- Own it: We transcend our job descriptions and relentlessly follow through on our commitments.
- Go all out: We work quickly and with conviction.
Company Summary: Cellarity’s mission is to fundamentally redesign the way drugs are created for the sake of bringing new hope to patients. By shifting the focus from a single target to the underlying cellular dysfunction, we unravel the complexity of disease biology and create medicines that were never before possible. The company has developed unique capabilities that link biology and chemistry with high dimensional -omic data from which we design medicines against the cellular signature of disease. The Cellarity platform allows us to uncover new biology in diseases even in the absence of known causal targets. The company has drug discovery programs underway in several disease areas, including metabolic disease, hematology, and immunology.
Cellarity is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Cellarity does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Cellarity or its employees is strictly prohibited unless contacted directly by Cellarity’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Cellarity, and Cellarity will not owe any referral or other fees with respect thereto.