SIGA Technologies, Inc. (www.siga.com) is seeking an experienced Director, Drug Metabolism and Pharmacokinetics (DMPK) to join our R&D team in Corvallis, Oregon. This position oversees the scientific, technical and administrative activities related to drug metabolism and pharmacokinetics. As a leader of this functional area, the Director is both an individual contributor and a strategic partner influencing pre-clinical strategy. This position requires an advanced degree in a relevant field (Ph.D. or equivalent) with at least 12-15 years of demonstrated industry experience in DMPK and preclinical drug development. The successful candidate will be familiar with Food and Drug Administration (FDA) guidance in the areas of pharmacology and toxicology, clinical pharmacology and good laboratory practice principle. Regulatory interaction and government contracting experience in a pharmaceutical setting is required. The Director, Drug Metabolism and Pharmacokinetics is a direct report to the Chief Scientific Officer. This is a full time (40 hours/week) position eligible for SIGA’s full benefits package with compensation for relocation offered. Travel may be required less than 5% of the time.
Responsibilities for this position include:
Planning, developing, and overseeing ADME, PK/PD, PBPK, and toxicology projects
Collaborating with members from SIGA’s Chemistry Manufacturing and Control (CMC), Non-clinical, Clinical, Regulatory, and Quality teams as necessary
Identifying, selecting and qualifying Contract Research Organizations (CROs)
Managing the conduct of DMPK studies carried out by CROs, including review of protocols, reports and data presentations
Compiling and presenting data to internal and external audiences
Assisting in clinical study design and conduct, and analyzing the study data
Assisting in the preparation of regulatory filings including but not limited to Investigational New Drug applications (IND), New Drug Applications (NDA), New Drug Submissions (NDS), and Marketing Authorization Applications (MAA)
Working closely with SIGA’s Project Management Team in the reporting of data, study progression and next steps
Reviewing scientific literature to understand current trends in antiviral research, drug discovery, and vaccine development
Reviewing regulatory guidance (FDA, European Medicines Agency (EMA), Health Canada, etc.) as it is released to stay current in the expectations and requirements associated with regulatory filings
Attending regularly scheduled meetings with SIGA’s Customer(s), upper management and internal project teams
Attending meetings with the FDA, EMA, Health Canada, etc. as necessary to support submissions and regulator question responses
Minimum Qualifications include:
Advanced Degree (Ph.D. or equivalent) in a relevant field.
12-15 years of industry background in DMPK and preclinical drug development.
Familiarity with pharmacokinetic modeling software such as WinNonlin®
Experience in preparing relevant modules (e.g. Module 2.6.2, Module 2.7.1, Module 2.7.2, etc.) for NDA submission
Experience in preparing data for presentations and publications
Regulatory interaction and government contract experience.
Necessary Special Requirements:
Familiarity with government-funded projects
Ability to manage the output of CROs including the quality and completeness of data and timely receipt of deliverables according to a pre-determined schedule.
Working knowledge of commonly used bioanalytical assays
The successful candidate will possess the following knowledge and abilities:
Must be detail oriented and comfortable in a fast-paced, rapidly changing work environment requiring the ability to prioritize and multi-task.
Able to work independently as well as in groups, and must have excellent oral and written communication skills.
Must have a thorough understanding of good laboratory practices and their application.
Familiarity with FDA guidance in the areas of pharmacology and toxicology, clinical pharmacology and good laboratory principles.
Is a team player who can work flexibly and enthusiastically within a small business environment.
SIGA is a commercial-stage pharmaceutical company focused on designing and developing novel countermeasures to prevent and treat serious infectious diseases, with an emphasis on biological warfare defense. On July 13, 2018, the United States Food & Drug Administration (FDA) approved oral TPOXX for the treatment of smallpox. SIGA is considered a leading drug development company in the biodefense arena. Its portfolio of existing drug candidates and its platform for developing additional countermeasures against potential agents of biological warfare are intended to fill a critical need for safe and effective treatments.
SIGA offers a challenging, dynamic environment with growth opportunity, competitive compensation, and a full benefits program.
SIGA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity, sexual orientation, marital status, age, national origin, predisposing genetic characteristics, unemployment status or veteran’s status and will not be discriminated against on the basis of disability.