Sr. Scientist, Toxicology

Research Waltham, Massachusetts


Description

Our Research team is growing and we have a need for an experienced Scientist, Toxicology to help us grow our Non Clinical development programs.

Apellis is looking to hire a highly analytical and knowledgeable toxicologist to join the Nonclinical Development team. Reporting into the Sr Director, Toxicology, this individual will be uniquely positioned to contribute to a multitude of projects in early discovery through late-phase development. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a collaborative environment in Waltham, MA.  Candidates should have in-depth working knowledge of toxicology and safety assessment and demonstrate the ability to succeed in a fast-paced environment.

Key Responsibilities

  • Provide expert support and guidance on nonclinical safety assessments to the project teams. Serve as a key resource for toxicology, providing scientific knowledge and expertise to cross-functional project teams;
  • Design & execute investigative toxicology studies, based upon off & on-target safety profiles of the candidate drugs;
  • Develop nonclinical safety assessment strategies for lead candidates with respect to clinical development plans for Ph I to Ph III;
  • Oversee nonclinical toxicology studies at various external Contract Research Organizations (CRO). Initiate appropriate processes for contract implementation, protocol development, and timeline optimization for toxicology studies;
  • Monitor toxicology studies for appropriate conduct, accuracy and timely execution; audit raw data for accuracy, review draft reports and finalize as submission-ready documents for regulatory authorities;
  • Proactively respond to study issues and facilitate timely resolutions with CROs and consultants;
  • Prepare verbal and written summaries for internal discussions;
  • Liase with cross-functional teams (e.g. Research and Translational Medicine, Clinical, Regulatory, CMC) to develop optimal strategies to address specific safety issues;
  • Review and/or author relevant pharmtox sections of various regulatory documents (e.g., pre-IND briefing documents, INDs, IBs) and ensure their compliance with various regulatory agencies/guidelines;
  • Other duties as assigned.


Education, Registration & Certification:

  • M.S. with 8 -12 years or Ph.D. with 5 -7 years industry or CRO experience in safety assessment of large and small molecules, biologics, and gene therapy products;
  • Board Certification in Toxicology (DABT) preferred;
  • Extensive experience with outsourcing and vendor selection and management covering all aspects of non-GLP and GLP outsourced studies;
  • Familiarity with US, EU, and Japan regulatory requirements;
  • Ability to work independently in a fast-paced environment with frequent course correction;
  • Excellent communication (verbal and written) and presentation skills;
  • Ability to travel to manage CRO/vendor collaborations (up to 20%).

Experience, skills, knowledge and abilities:

  • Extensive experience with outsourcing and vendor selection and management covering all aspects of non-GLP and GLP outsourced studies
  • Familiarity with US, EU, and Japan regulatory requirements and GLP/ICH guidelines
  • Ability to work independently in a fast-paced environment with frequent course corrections
  • Excellent communication (verbal and written) and presentation skills
  • Ability to travel to manage CRO/vendor collaborations (up to 20%)

Physical Demands and Work Environment:

This is largely focused on Lab work and requires standing for prolonged periods of time. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and/or laboratory one and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

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EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.