Experienced DMPK/Clinical Pharmacology Scientist: Senior Consultant
Aclairo Pharmaceutical Development Group, Inc. is an independent drug development consultancy with a mission to deliver independent and objective clinical pharmacology, preclinical ADME and toxicology, and regulatory advice to the biopharmaceutical industry. Aclairo’s staff comprises seasoned consultants with decades of industry, FDA, and CRO experience. We assist our clients in development of pharmaceutical, biologic, device, and gene therapy products.
Aclairo is seeking an experienced, independent, and proactive technical expert in DMPK/Clinical Pharmacology to join our staff of highly trained professionals. This is not an entry-level position. The successful applicant will be able to contribute scientific knowledge, analytical skills, experience, and insight to the analysis of data, development strategies, the preparation of reports, and the production of regulatory documents. The successful applicant will also be able to independently write, without supervision, clinical/clinical pharmacology study reports, nonclinical TK reports, and regulatory PK and ADME sections of FDA submissions (e.g., background packages, INDs, NDAs, CTDs, and BLAs) according to applicable guidelines and company policies.
Major Duties & Responsibilities:
- Work independently and with project teams to 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.
- 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.
- Formal Education & Experience: BS/MS degree required; advanced degree (PhD, PharmD) a plus.
- In-depth understanding of, and demonstrated ability to effectively apply, the principles of PK and PK/PD theory, including analysis and modeling of PK and PK/PD data.
- Substantial experience (minimum of 5 years) writing nonclinical and clinical regulatory submission documents, including human and animal ADME.
- 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.
- Proven excellent spoken and written English.
- Proficiency in Microsoft Office and WinNonlin. Expertise in population and/or PBPK modeling/analysis a plus.
Aclairo is a wholly owned subsidiary of EPL, Inc., an employee-owned company.
Aclairo employees work in our office in Vienna, VA or virtually from their homes. No subcontractor work is available. This is a salary position with full benefits and promotion potential. Salary commensurate with experience and education.
Senior Consultant in Toxicology
This position requires prior recent experience within FDA
Aclairo PDG, Inc. consults to 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.
Senior consultants in toxicology have more than 15 years of experience and a doctorate level degree. They are expected to have intimate knowledge of toxicological science, regulatory nonclinical knowledge, as well as extensive knowledge of drug/biologic development.
Aclairo is seeking specifically a senior consultant with FDA CDER experience. The successful applicant may be a seasoned reviewer, supervisor, or at the office level in the areas of pharmacology, toxicology, or pathology. Experience with other FDA Centers and worldwide health authorities a plus.
- Provides scientific and innovative advice with an advanced level of technical skill and insight.
- Provides regulatory insights across CDER divisions
- Demonstrates and clearly articulates an understanding of client needs
- Produces a high-quality work product that is acceptable, on time and within budget
- Effectively manages deadlines, multi-tasks and works well and remains calm under pressure
- Participates in business development activities
- Effectively communicates with clients and manages the client relationship where appropriate
- Engages directly or assists in the publication of relevant articles
- Demonstrates excellent communication skills, written and oral
- Manages assigned projects/tasks providing coordination and thought leadership
- May be responsible to help in the preparation of project plans and determination of task assignment
- Participates in the training and development of junior staff
- Models, promotes and demonstrates collegiality with all company employees
Personal Growth and Development
- Maintains current scientific and regulatory knowledge by initiating the appropriate internal or external educational/learning pursuits
- Ensures personal development goals are in place and carried out in agreed timeframe
Required Education and Skills
- Advanced degree in a life science or related field of study (PhD and/or DVM)
Susan Wilson (Swilson@Aclairo.com) or
Hilary Sheevers (Hsheevers@Aclairo.com)
Please include your CV and a cover letter.