Remote Clinical Pharmacology Consultant
Posted on: June 19, 2022
Remote opportunity with competitive base and lucrative bonus
This Jobot Job is hosted by Brendan Thomas
Are you a fit? Easy Apply now by clicking the "Apply" button and
sending us your resume.
A Bit About Us
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.
Why join us?
- Competitive base salary + lucrative bonus structure
- Comprehensive health, dental and vision (75% paid by
- Life/AD&D, Short & Long Term Disability Insurance
- 401(k) + 3% match
- Generous PTO
- Strong business pipeline w/ job security
- Award-winning team
- Great company culture & atmosphere
- Work from home
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
- 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
- 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
- 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
- Participate in the training and development of consultants and
- 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
- Substantial experience (minimum of 5 years) writing nonclinical
and clinical regulatory submission documents, including human and
- In-depth understanding of drug development and the regulatory
- Knowledge of contract laboratory functions, and ability to
interact with laboratories to direct programs
- Accurate and detail oriented with excellent inter-personal
- 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
- Ability to effectively meet deadlines
- Ability to function effectively alone or as part of a team
Interested in hearing more? Easy Apply now by clicking the "Apply"
Keywords: Jobot, Rockville , Remote Clinical Pharmacology Consultant, Professions , Rockville, Maryland
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