Scientist – Developmental Toxicology

Akebia Therapeutics, Inc.

Toxicology

July 11, 2014

Scientist – Developmental Toxicology

Location: Cambridge, MA

 

Akebia Therapeutics is looking for Toxicologist to work with an  integrated individual group responsible for developing our understanding of the biological fate of candidate drug molecules from pre-clinical studies through clinical investigation., This person will provide the execution of the strategy for generating the Toxicology and ADME data required to support all phases of global development including: studies to support drug candidate optimization and selection, generation of Toxicology data packages to support regulatory submissions (i.e. IND, NDA, MAA) as well as the data required for us to understand the performance of our products in the clinical setting.  He or she will provide strong, hands-on leadership to the group, setting specific measurable milestones and monitoring progress against these goals.

 

Responsibilities

 

  • Develop and drive non-clinical ADME and toxicology drug development plans for small molecule compounds
  • Identify and resolve non-clinical study operational issues and maintain project timelines
  • Develop and execute safety-related issue mitigation or resolution plans
  • Maintain a robust network of CRO and consultant relationships to ensure scalable, flexible support capacity to respond to program needs at all stages of development
  • Interact with CROs to coordinate, design and monitor GLP and non-GLP pharmacokinetic, safety pharmacology, and toxicology studies
  • Critically assess the analysis and interpretation of study outcomes and review and edit study reports.
  • Coordinate cross-functional activities necessary for the effective conduct of pharmacokinetic and safety assessment studies
  • Communicate study findings, relevance, and interpretation to project teams
  • Prepare and edit non-clinical documents for regulatory submission (e.g. INDs, IBs, and regulatory briefing documents)
  • May interact with regulatory agencies on non-clinical matters
  • Maintain a current understanding of toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects
  • Maintain a current understanding of regulatory requirements and guidances

Desired Skills and Experience

•    BS/MS in toxicology, pharmacology or related field; PhD an advantage
•    DABT certification desirable but not required
•    A minimum of 5 years’ experience working in industrial pharmaceutical toxicology/safety assessment drug development
•    Experience with small molecules
•    Experience with pharmacokinetic assessments preferred
•    Experience with assessments for metabolism and drug-drug interaction is an advantage
•    Experience in oncology or ocular development and diabetic research is an advantage
•    Ability to synthesize and interpret diverse, multidisciplinary data sets
•    Experience participating on drug development teams and IND submissions
•    Experience in designing, monitoring and interpreting non-clinical safety studies
•    Excellent communication, multitasking, and collaboration skills
•    Extensive knowledge of FDA and ICH guidance documents including GLP regulations


Interested candidates should apply to careers@akebia.com
About Us:


We are a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor (HIF) biology and the commercialization of these products for patients with anemia secondary to chronic kidney disease and other indications.  Our lead product candidate, AKB-6548, has successfully completed a Phase 2a proof of concept study and is currently completing Phase 2b.  Following its IPO in March 2014, the company is preparing for expansion to support global phase 3 programs and commercialization.
www.akebia.com

Apply Now

  • Company Akebia Therapeutics, Inc.
  • Contact Name HR
  • Position Location Cambridge, MA
  • Minimum Preferred Education Ph.D.
  • Career Level Experienced Non-manager
« Back to list

StratAcuity


 

Fresenius Medical Care