Senior Scientist, Nonclinical Safety (56937)

Senior Scientist, Nonclinical Safety

Reports to: Head of Nonclinical Safety, Translational & Bioanalytics

Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary

Preclinical Safety Assessment has a significant role in the drug development process beginning in the early drug discovery phase and continuing through the entire drug development value chain resulting in successful registration and marketing approval. The incumbent (“Toxicologist”) will report directly to the Head of Nonclinical Safety, Translational & Bioanalytics and will be responsible for contributing to the design and conduct of nonclinical safety assessment programs, with emphasis on discovery/early and GLP toxicology study support, to enable progression of novel therapeutic agents through the drug development process, regulatory approval and post-marketing activities. Experience in study directing/study monitoring, including extensive knowledge and understanding of Good Laboratory Practices, and knowledge of applicable regulatory guidelines is required.

Primary Responsibilities

• Design and oversee the conduct, monitoring, interpretation, and reporting of discovery, exploratory and regulatory toxicity studies (non-GLP and GLP compliant)
• Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with affiliated nonclinical, clinical and regulatory development functions as necessary.
• Coordinate toxicological/nonclinical safety evaluations of development candidates locally and internationally with external contract laboratories (CROs) and development partners (external consultants).
• Responsible for contributing to authorship of pertinent sections of internal and external regulatory documents (IBs, CTAs, INDs, DSURs, etc.)
• Address and resolve toxicological issues arising in early drug development programs, and adequately assess the relevance of any toxicological findings to human safety
• Communicate critical and significant project information to various bodies including representing the nonclinical safety group in project and leadership teams
• Build strong scientific collaborations with external groups within both the academic and industrial sectors
• Collaborate on design of investigative toxicity studies in support of development compounds as needed
  
  

Qualifications And Key Success Factors

• Master’s or Ph.D. (preferred) in Toxicology or relevant field (pharmacology, pharmacy, biology, etc.); DABT Board certification is desirable.
• Minimum of 5 years of experience in the Biotech/Pharmaceutical Industry with a strong background in study directing at a pharmaceutical company, CRO or study monitoring in an industrial setting
• Proficient knowledge of general toxicology is required. Knowledge of reproductive toxicology, genetic toxicology, and safety pharmacology desired.
• Working knowledge of regulatory toxicology and ICH, US and international regulatory guidelines
• In depth understanding of Good Laboratory Practices (GLPs) and OECD regulations
• Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
• Excellent interpersonal and communication skills (proficient in the use of Outlook, Teams, Zoom, etc.), with the ability to develop important relationships that include trust and encourage diversity in all its forms.
• Highly organized and detail-oriented with a passion to deliver quality results.
• Familiarity with the Agile Way of Working (Workboard) desired
• REQUIRED: The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.
  
  

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)
  
  

To round out this world-class total rewards package, we provide base salary compensation in the range of $120,000 to $175,000 annualized. Final salary range may be modified commensurate with job level, education, and experience.

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE ® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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