We consult the pharmaceutical and biologic product industry in nonclinical (pharmacology and toxicology) clinical pharmacology and related regulatory areas. Our nonclinical consultation consists of strategic advice, overall program design, study placement and monitoring, regulatory document preparation, and position papers. Our consultants are located throughout the US and work virtually from their home offices. Our main office is in the Washington D.C. metro area, although this is a permanent remote position.

Provide strategic and operational consultation to the pharmaceutical, device, and biologics industries. Serve as internal project team leader and are encouraged to take on that role with client companies where appropriate. This role requires an experienced, independent, and proactive technical expert in DMPK/Clinical Pharmacology. Contribute scientific expertise, analytical skills, experience, and insight to study design and analysis/interpretation of study data, development strategies, the preparation of reports, and the production of regulatory documents. Independently write, without supervision, clinical PK/clinical pharmacology study reports, nonclinical PK/TK reports, and nonclinical PK, bioanalytical, biopharmaceutics, and Clinical Pharmacology regulatory sections of FDA submissions (e.g., background packages, INDs, NDAs, CTDs, and BLAs) according to applicable guidelines and company policies. The Sr. Consultant is expected to bring in new clients as well as new projects that provide work for other consultants/operational staff and to efficiently utilize company resources to provide operational and cost-efficient solutions to clients.

Major Duties & Responsibilities:

• Support our business development activities by bringing in new clients and projects, and developing opportunities to create new business.
• Work independently and with project teams to conceive, develop, and execute nonclinical and clinical DMPK/Clinical Pharmacology development programs, including translational PK and/or PK/PD modeling.
• Design scientifically and strategically sound DMPK/Clinical Pharmacology studies. Analyze and summarize data and/or integrate study results into the ongoing development strategy. Write protocols and reports for nonclinical ADME and Clinical Pharmacology studies.
• Design complete plans to support eCTD/NDA/BLA filings.
• Make decisions on the scientific and regulatory content and format of documents and decide on steps needed to complete high-quality documents according to timelines.
• Work independently and with project teams to prepare written documents under strict timelines.
• Work effectively with company employees and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
• Review technical and regulatory documents for accuracy, content, and strategy.
• Independently grow a consulting practice; cultivate established relationships with current clients via DMPK/Clinical Pharmacology support and acquire new clients.
• Consistently meet billable hour targets
• Engage directly or assist in the publication of relevant articles and presentations or symposia at professional meetings.
• Participate in the training and development of consultants and operational staff
• Model, promote and demonstrate collegiality
• Maintain current scientific knowledge by initiating the appropriate internal or external educational/learning pursuits
• Ensure personal development goals are in place and carried out in agree timeframe

Required Education and Skills:

• Advanced degree (e.g. PhD, PharmD) required
• Minimum of 15 years of relevant pharmaceutical research and development, and/or regulatory agency experience
• In-depth expertise in all facets of ADME, PK, and PK/PD theory, including analysis and modeling of PK and PK/PD data
• Demonstrated ability to effectively apply PK and PK/PD principles to the strategic design of nonclinical and clinical studies, and integration of these studies into research and development programs
• Substantial experience (minimum of 5 years) writing nonclinical and clinical regulatory submission documents, including human and animal ADME
• In-depth understanding of drug development and the regulatory environment
• Knowledge of contract laboratory functions, and ability to interact with laboratories to direct programs
• Accurate and detail oriented with excellent inter-personal skills
• Excellent written and oral communication skill in English
• Proficiency in Microsoft Office, and WinNonlin and/or equivalent PK/PD modeling and analysis program(s)
• Expertise in population and/or PBPK modeling/analysis a plus
• Ability to effectively meet deadlines
• Ability to function effectively alone or as part of a team