Remote Senior Project Manager - Toxicologist
Jobot Jeffersonville, IN
- Expired: over a month ago. Applications are no longer accepted.
This Jobot Job is hosted by: Brendan Thomas
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A bit about us:
We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.
Why join us?
We offer well-defined career development path, inspiring incentive mechanism and diversified talent development programs to enable your fast growth. Join our award-winning team.
Employee assistance program
Flexible spending account
Health savings account
Paid time off
Essential Job Functions:
Work with or without supervision in a highly motivated project management team and very dynamic environment.
Provide technical support during new business development phase, including but not limited to, understanding various regulations and requirement for IND submissions in US, China, EMA and elsewhere, making assessment of clients’ program(s), preparing program proposals and preliminary study designs based on compound’s nature, clinical indication, intended clinical trial regime, data from previous studies, and the jurisdiction(s) the sponsor intends to submit, etc.
Lead and manage nonclinical part of IND-enabling program: developing program execution plan (Gantt Chart), monitoring program execution starting from a drug candidate, through conducting various required studies for Pharmacology, DMPK/ADME, Toxicology, Bioanalysis, to regulatory submissions, hosting regular project meetings to update/discuss program status, study results/issues and resolutions. Also coordinate with other divisions of the company for extended IND programs when needed.
During the program execution phase, staying on the top of project with continued scientific and technical support, proactively identify potential issues and provide constructive suggestions.
Timely communication with clients and to key project contributors from functions/business units within the company to facilitate the project execution through email, tele-conference, zoom meeting and/or visiting, etc.
Monitor relevant scientific advancement by searching and reviewing scientific literature and provide update to the group and business units.
PhD or MS in toxicology, pharmacology, DMPK or other related fields
Minimum of 3 years working experience after PhD degree or 5 years after Master degree
Experience in vitro or in vivo studies in drug discovery and development desired. Experience in toxicology and/or DMPK are preferred
Project manager experience in managing nonclinical programs preferred
Excellent English and Chinese communication skills in verbal and writing
Good interpersonal skill and teamwork spirit
Highly independent person with accountability
Capability to conduct research and literature search
Knowledge / Skills / Abilities:
Strong interpersonal skills both oral and written
Computer proficiency in MS Word, Excel, Outlook, and PowerPoint, and other applicable software
Well organized, detail oriented, and adaptable to changes
Ability to work under pressure of multiple projects and deadlines
Ability to effectively prioritize workload and manage changes in direction
Ability to work in a team environment
Familiarity with and adherence to regulatory guidelines consistent with company requirements
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
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