Program Manager

Location

Delaware, OH | United States

Job description

at WuXi AppTec in Middletown, Delaware, United States

Overview

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions.

At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life.

We are seeking a Program Manager for our US PM Group. The position will be home-based and remotely work with BD team in US and Operation team in China. Due to the needs of deep engagements, fluency in Mandarin would be helpful, but not necessary.

Responsibilities

The Program Manager will mainly support and manage clients’ IND (Investigational New Drug) and follow the molecule programs in the US. He or she will closely work with the project teams and scientists of relevant business units in China (Shanghai, Suzhou, Chengdu, and Qidong etc.).

Essential Job Functions:

+ Work with or without supervision in a highly motivated project management team and very dynamic environment.

+ Provide technical support during 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 indications, 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.

Qualifications

Experience/Education

+ PhD, MS, or BS in toxicology, pharmacology, DMPK or other related fields

+ Minimum of 3 years working experience after PhD degree or 5+ years after master’s or bachelor’s degree

+ Experience in vitro or in vivo studies in drug discovery and development desired. Experience in toxicology and/or DMPK are strongly preferred

+ Project manager experience in managing nonclinical programs preferred

+ Excellent English communication skills in verbal and writing, and nice to have with Mandarin.

+ 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 and flexibility to work across different time zones

+ Familiarity with and adherence to regulatory guidelines consistent with company requirements

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability (

Job Locations US

Job ID 2023-12491

Job tags

Salary