Principal Scientist, Toxicology

  • location: Cambridge, MA
  • type: Permanent
  • salary: $80,000 - $120,000 per year
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job description

Principal Scientist, Toxicology

job summary:
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location: Cambridge, Massachusetts
job type: Permanent
salary: $80,000 - 120,000 per year
work hours: 9 to 5
education: Doctorate
The Principal Scientist will lead all aspects of toxicology work for select nonclinical programs to enable drug candidates from research through development and IND enabling studies. The principal scientist will design, execute, and interpret nonclinical safety studies conducted in multiple species, and will be heavily involved in regulatory submissions and interactions with various health authorities as well as the internal clinical team. The successful candidate must have the ability to multitask and to function effectively in a fast-paced environment. Be capable of conducting work independently, but also capable of pulling in subject matter experts when necessary to lead the conversation. Will maintain extensive scientific awareness and presence in toxicology, publishes manuscripts and posters, presents at scientific conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.

  • In conjunction with program teams and the nonclinical sciences team, develop toxicology strategies and provide expert support to research and development projects
  • Collaborate on the design of non-GLP investigative and pharmacology studies to support development compounds, as needed
  • Review, summarize and integrate complex data sets across multiple disciplines
  • Manage the preparation and presentation of nonclinical safety data for project teams, portfolio management, internal /external partners and/or scientific groups
  • Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
  • Lead finalization of toxicology reports and manage the tabular presentation of data in accordance with CTD format
  • Support the preparation of national and international regulatory submissions and interactions with health authorities and be capable of effective communications with regulatory authorities
  • Interact cross functionally with Research, Regulatory, Clinical and Manufacturing
  • Work closely with clinical to ensure toxicology support for clinical trial designs
  • Mentor junior members of the team by providing scientific input and leading by example
  • The qualified candidate will serve as a resource for the department and project teams, proactively keeping colleagues/leadership updated with industry trends.
  • Doctorate degree & 5-10 years of scientific experience OR Master's degree & 8-10 years of scientific experience OR Bachelor's degree & 10-15 years of scientific experience in preclinical toxicology and drug development in the pharmaceutical/biotechnology sector
  • Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
  • Experience working with Contract Research Organizations
  • Ability to develop and deliver clear and concise presentations for both internal and external meetings
  • Outstanding written and verbal communication skills
  • Ability to multi-task and change quickly change priorities

  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter
  • Adoption assistance and discounts to local childcare centers, as well as access to
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
skills: IND, FDA, GLP (Good Laboratory Practice), CTD Structure, Regulatory Affairs Operations, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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