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.
Project Manager – Aclairo Pharmaceutical Development Group
Aclairo® Pharmaceutical Development Group, Inc., is seeking a Project Manager to oversee large projects and contribute to the smooth flow of billable operations among Aclairo employees working in the office and at remote locations. The ideal candidate should have a bachelor’s degree (preferably in a scientific discipline), a minimum of 3 years as a project manager supporting the completion of large projects for interdisciplinary teams, and experience in the pharmaceutical industry or FDA, including general knowledge of eCTD documents. Excellent people skills, written and oral communication skills, and organizational skills are expected. Experience in developing budgets and working in a virtual team environment is a plus.
Major Duties and Responsibilities:
- Prepare project plans and help define assignment of tasks; attend/organize project kickoff and progress meetings
- Function as the primary project leader for certain projects; oversee the quality of work delegated to others
- Demonstrate the ability to work as part of a virtual team, as well as to function independently; model, promote, and demonstrate collegiality
- Develop, with management, a smooth and consistent proposal process for large projects; participate in management of project budgets, including review of monthly invoices
- Work with Aclairo professionals to balance workload and client projects, and give input on strategies for completing tasks with a quality product
- Effectively manage deadlines, multi-task and demonstrate the ability to work well under pressure
- Update and develop written procedures pertaining to project management and process efficiency appropriate for a semi-virtual team
- Identify and utilize software to support project management
- Effectively communicate with clients directly and manage the relationship where appropriate; demonstrate and clearly articulate an understanding of the needs of each client; exhibit professional conduct at all times when interacting with clients and fellow employees; hold the highest ethical standards
- As needed, co-author INDs, NDAs, CTDs, position papers, etc., and other scientific services; produce a high quality work product, on time and within budget
- As the PM group grows, hire, train and manage new staff; Participate in the training and development of junior staff
Requirements: Bachelor’s degree (preferably in a scientific discipline), a minimum of 3 years as a project manager, and some experience in the pharmaceutical industry or at FDA. Excellent people skills, written and oral communication skills, and organizational skills.
Experience in developing budgets a plus.
Aclairo® Pharmaceutical Development Group, Inc. is committed to delivering independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Every member of Aclairo’s staff strives to provide our clients with superior advice, analysis, work product and program assistance.
Unparalleled Industry Experience
Aclairo’s unique experience and capabilities help our clients’ development programs succeed. Our senior consultants are experienced ex-FDA or industry specialists and can provide expert guidance in the areas of toxicology, regulatory, ADME and clinical pharmacology drug development. In addition, we can provide full program management, study monitoring and support the gamut of regulatory document preparations including:
- Final Study Reports
- GLP Toxicokinetic Reports
- Regulatory Applications (e.g., INDs, NDAs, BLAs, MAAs, PIPs, PSPs)
- Investigator Brochures
- Expert Reports
- FDA Response Documents
To apply, please email a cover letter, your CV, and salary expectations to email@example.com and put in the subject line Project Manager Job.
Principals only. Recruiters, please don’t contact this job poster. Do not contact us with unsolicited services or offers.