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Vice President, Analytical Development

2 months ago

Reston, Virginia, United States The Higgins Group, Inc. Full time

About The Higgins Group, Inc.

The Higgins Group, Inc. is a leading biotech company dedicated to discovering and developing new drugs that translate frontier cancer targets through exceptional drug discovery, delivering revolutionary medicines on behalf of cancer patients. Our innovative science draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms, and therapeutic approaches.

To deliver our vision, we work relentlessly in pursuit of cutting-edge therapeutic approaches to some of the toughest cancers. Our current focus is RAS-addicted cancers, which account for 30 percent of all new human cancer diagnoses. As a new member of our team, you will join other outstanding scientists who are helping lead our efforts in the discovery and development of new medicines for unmet needs in cancer.

The Position

We are seeking a highly experienced and skilled Vice President, Analytical Development & QC to play a senior leadership role within our Pharmaceutical Development and Manufacturing (PDM) organization. The successful candidate will be accountable for analytical development and operations in support of clinical development and commercialization of our pipeline compounds. The individual will provide technical, organizational, and strategic leadership, and work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are executed seamlessly and in alignment with our integrated development plan and program timelines.

Key Responsibilities:

  • Lead analytical development and operations from early to late development through commercialization
  • Be accountable for analytical related development strategies, overseeing execution of functional activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization
  • Author/review/approve the relevant CMC sections to enable global regulatory filings
  • Lead cross-functional CMC team for the project(s) assigned to ensure adequate development and execution of CMC plan/strategies as needed
  • Serve as a project core team member and communicate CMC strategy and project status to the key stakeholder cross-functionally and assist in driving decision-making
  • Collaborate with cross-functional teams (drug substance, drug product, supply chain, quality, CMC regulatory, CMC PM, Clinical, DMPK, and tox, as well as program management) to ensure CMC and program goals are met
  • Lead the efforts to assess/identify potential suppliers for analytical development and QC activities in support of drug substance and drug product development and manufacturing with adequate risk assessment
  • Travel to CDMOs and/or CTLs for the vendor assessment and qualification, as well as analytical activities oversight as needed

Requirements:

  • Preferably a PhD (minimum MSc degree) in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field is desirable
  • Substantial experience in the pharmaceutical/biotech industry with a sound track record of technical expertise and organizational leadership, early and late phase analytical development and operations experience of small molecules with commercial experience a plus
  • Extensive experience in late phase innovative drug development and commercial launch with global CMC regulatory filings (IND/NDA/MAA, etc.)
  • Proven track record of strategic leadership and management with at least 10 years on the management role
  • Demonstrated strong project and cross-functional team leadership, as well as people management skills
  • Thorough understanding and working experience of innovative drug development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
  • Extensive working experience with management and oversight of the analytical activities at CDMOs and/or CTLs
  • Strong problem-solving skills with strategic and sound technically driven decision-making ability
  • Effective written and verbal communication skills and interpersonal skills
  • Innovative team-player with high energy for our dynamic company environment