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Director/Sr. Director, Bioanalytical Sciences (Small Molecule Experience Preferred)

Boston, MA

Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.

Job Summary

The successful candidate will have a proven track record of working in the nonclinical DMPK and clinical PK/clinical pharmacology area supporting R&D programs. They will have experience with working in a highly collaborative team environment, interfacing with multiple departments across the organization and developing strategic relationships with preferred vendors. They will work closely with other clinical and nonclinical disciplines and ensure that objectives for programs are achieved. 

Key Responsibilities

  • Contribute to the design of bioanalytical studies to understand the pharmacokinetics of molecules
  • Represent bioanalytical sciences in multifunctional research and development project teams and in nonclinical and clinical study teams
  • Collaborate with other functions, but particularly clinical pharmacology and DMPK/Toxicology to interpret nonclinical and clinical data
  • Ensure that appropriate bioanalytical support of DMPK/clinical PK/pharmacology studies are included in program plans and timelines
  • Ensure the quality of bioanalytical data and communicate results to internal and external stakeholders
  • Ensure that bioanalytical methods are developed and validated to required standards
  • Contribute to the cross-functional preparation and review of technical reports
  • Serve as a subject matter expert in composing responses to regulatory queries
  • Identify, qualify, engage, and manage external providers of bioanalytical PK services
  • Provide in-depth scientific expertise and technical leadership as well as resource and relationship management of external networks
  • Deliver and communicate results to project teams and other stakeholders to enable decision making
  • Recommend, initiate, lead and champion new bioanalytical innovations from external, global and local sources to ensure cutting-edge science is applied to drug project issues
  • Provide scientific input into regulatory submissions, including clinical study reports, briefing documents, and responses to regulatory queries

Professional Experience and Qualifications

  • BS or higher in a relevant scientific discipline
  • A minimum of 10+ years in pharmaceutical/biotech R&D supporting nonclinical DMPK and the clinical PK pharmacology area
  • Experience conducting or supervising conduct of bioanalytical studies in support of nonclinical DMPK/Toxicology and clinical studies; contributing to nonclinical and clinical reports including relevant sections for regulatory submissions
  • Strong knowledge of bioanalytical sciences, including method development and validation and nonclinical and clinical study requirements
  • Strong analytical and problem-solving skills, with attention to detail
  • Hands on experience with bioanalytical studies and an in-depth understanding of design and execution for support of research and development
  • Experience working with external vendors to provide bioanalytical support for programs
  • Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge
  • Up to date knowledge on regulatory guidance related to bioanalytical support of clinical trials
  • Team player with strong negotiation, problem-solving, and strategic influencing skills
  • Strong customer focus with the ability to have robust discussions with other stakeholders to ensure that project, scientific and resource demands are aligned
  • Track record of successful problem solving, high quality science and influencing of stakeholders, particularly in a drug project context
  • Clear and open communication skills, and experience communicating across cross functional partners

 

Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. 

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