VP, Clinical Pharmacology
Seaport Therapeutics is seeking someone to lead Clinical Pharmacology. The VP, Clinical Pharmacology leads strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments for any study needs.
The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary GlyphTM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit www.seaporttx.com
Responsibilities
- Leads Clinical Pharmacology/PK/PD activities and multiple major projects. Assists R&D senior management in the selection of action plans that best meets drug development business objectives.
- Identifies issues and helps with issue resolution. Conducts risk assessments and assists in the development of contingency plans. Assures project remains in alignment with strategic objectives.
- Provides overall timelines to assess portfolio opportunities. Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/performance).
- Provides scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
- Responsible for evaluating technical, scientific aspects of all projects along with Clinical Pharmacology management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions.
- Leads Clinical Pharmacology regulatory documents writing, submission and response to Regulatory agency comments.
- Independently conducts due diligence assessments, summarizes results and represents Clinical Pharmacology on business development teams.
- Influences strategic PK/PD decisions for the department.
- Performs functions and responsibilities with the highest regard for quality and timeliness. Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software.
Qualifications
- PhD with 10+ years of experience or Pharm D with typically 9+ years of experience in a relevant field, MS or equivalent education with typically 15+ years of Relevant experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
- Strong competency in building mathematical models is required (in commonly used languages such as MATLAB, NONMEM, Phoenix, Python, or R)
- Excellent interpersonal skills
- Knowledge and experience in multiple therapeutic and/or functional areas
- Experience across range of development phases
- Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects
- Scientific project leadership or related experience
- Project management skills such as scope management, progress tracking/driving as well as time management
