ProPharma Group
This listing was posted on ProPharma Group (via Broadbean).
Vice President, Nonclinical Emerging Therapies
Location:
Washington
Description:
The Vice President, Nonclinical Emerging Therapies is responsible for the conduct of regulatory activities associated with the nonclinical development of therapeutic drug, biologic, and device products. This role will serve as the point person interfacing with clients on nonclinical matters pertaining to the above therapeutic areas, especially those considered to be new/emerging therapeutic modalities from discovery through clinical development and approval.Essential Functions * Coordinate and balance priorities of various stakeholders (corporate, scientific, clinical) in the context of regulatory requirements, through active participation in Product Development Teams. * Provide critical review of relevant documentation supporting regulatory applications. * Ensure timely preparation of cogent, organized, and scientifically valid submissions to FDA. * Prepare for and participate in meetings and teleconferences with regulatory agencies; leading nonclinical discussions interactions with the FDA, if requested. * Develop and implement effective strategies to assist in obtaining regulatory approval of products with optimum cost effectiveness and compliance. * Provide expertise in translating regulatory requirements into effective plans. * Support new product development efforts, including interfacing with client development team(s) and/or contract organizations. * Assist with business development to win new business.Necessary Skills and Abilities * Ability to engage with regulatory agencies in addressing scientific and regulatory nonclinical issues, including preparation and submission of successful briefing packages and investigational and marketing applications. * Solid understanding of multiple routes to clearance or approval of drugs, biologics, and medical device combination products. * Excellent working knowledge and application of testing and regulatory standards. * Demonstrated ability to manage multiple and diverse projects concurrently. * Demonstrated ability to develop positive relationships and collaborations. * Excellent oral and written communication with cross-functional collaboration skills. * Strong analytical skills; a strategic thinker, planner and implementer.Experience Requirements * 10+ years in positions of leadership in Regulatory Sciences within consulting and/or regulated drug/biologic development organizations. * Experience leading teams of technical professionals.Educational Requirements * Master's degree in Life Sciences * PhD preferred
Company:
Propharma Group
Posted:
May 16 on Broadbean
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to ProPharma Group (via Broadbean)
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.
More About this Listing: Vice President, Nonclinical Emerging Therapies
Vice President, Nonclinical Emerging Therapies is a Executive VP Job at Propharma Group located in Washington, DC DC. Find other listings like Vice President, Nonclinical Emerging Therapies by searching Oodle for Executive VP Jobs.
Vice President, Nonclinical Emerging Therapies is a Executive VP Job at Propharma Group located in Washington, DC DC. Find other listings like Vice President, Nonclinical Emerging Therapies by searching Oodle for Executive VP Jobs.