Senior Director, Toxicology

Constellation Pharmaceuticals

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 02/22/2021
  • Website: www.constellationpharma.com
  • Company Address: 215 First Street, Suite 200, Cambridge, MA , 02142

About Constellation Pharmaceuticals

Constellation Pharmaceuticals is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics that address serious unmet medical needs in patients with cancers associated with abnormal gene expression. Our integrated epigenetics platform enables us to validate targets and generate small molecules against these targets that selectively modulate gene expression in tumor and immune cells to drive anti-tumor activity. We are able to target a broad variety of epigenetic regulators using our platform and have generated development candidates acting against distinct classes of those regulators.

Job Description

The Sr. Director of Toxicology will be responsible for comprehensive toxicology assessment of all pre-clinical and clinical product candidates. You will be a core member of the program teams providing toxicology expertise, planning, executing and evaluating toxicology assessments and delivering on data that promote program progression and de-risk our product candidates. CNST is currently focused on small molecules as the therapeutic modality and oncology as the priority disease area of interest and in this role you will devise, drive, and implement (with internal collaborations and working with consultants/external partners) strategies and analyses necessary to evaluate the performance of our development candidates, enable IND and NDA filings of product candidates and further contribute to the optimization of our development programs. We are looking for a Board-certified toxicologist with extensive experience in the development of new molecular entities with leadership qualities.  We are #BrighterTogether

 

In this role you will:

  • Responsible for Preclinical Safety Assessment of CNST development candidates.
  • Designs, implements, drives, and monitors toxicology strategies for portfolio assets.
  • Works with internal teams and external partners to execute on development program team objectives.
  • Contributes to development program strategy, study execution, data review/analysis, study reports, protocol preparation and regulatory document preparation; write and review non-clinical toxicology summary documents.
  • Oversees vendors and consultants as appropriate to execute on toxicology studies.
  • Leads toxicology contributions for all regulatory documents. Leads the resolution of toxicology-related queries from drug regulatory agencies, writing and reviewing responses to regulatory on toxicology-related queries.

 

Key things about you:

  • PhD in Toxicology, Pharmaceutical Sciences, or related field is required.
  • A minimum of 10 years’ experience in the biopharma industry in a Toxicology role and proven ability to represent toxicology perspectives on project teams and with external partners.
  • Proficiency in the development of new molecular entities, especially with small molecules.
  • Track record of toxicology leadership on multiple Oncology development programs.
  • Experience with IND and NDA Oncology submissions and regulatory interactions.
  • Experience partnering with DMPK, Regulatory Affairs, Clinical, CMC and Translational Science colleagues to ensure comprehensive Toxicology approaches are developed as part of the program strategy.
  • Experience working cross-functionally and working with external partners.
  • Ability to perform in fast-paced, dynamic, constantly evolving environment.
  • Excellent communication and organizational skills and attention to detail.
  • Strong time management skills; ability to prioritize multiple tasks efficiently.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.