This company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
Nature and Scope
The position of Manager within Clinical Research and Development is primarily responsible for clinical development programs related to generic products and the expansion of the pipeline. We have several unapproved Multisource Generic products that require prioritized clinical strategic plans aligned with regulatory activities for approval of use in targeted populations. Additionally, we seek pipeline expansion for Multisource Generic products via an expanding Business Development program.
Essential Duties and Responsibilities
- Strategic planning for pharmaceutical product development inclusive of
o Target indication evaluation, clinical development program design, protocol design, target patient population, current standard therapy, competitor identification, and regulatory agency interaction.
o Contribute scientific and clinical perspective to matrix teams including Research and Development (R&D), Regulatory and Medical Affairs, Manufacturing and Quality Controls, Commercial and Business Development during product development and regulatory strategy development and implementation.
- Oversee all aspects of multiple contemporaneous project(s) including RFP development, proposal review and evaluation, budget development and management, vendor selection and oversight.
- Identify and quantify program and project risks such as budgetary, timing, deliverables.
- Assist in the preparation and review of documents for regulatory submissions. Contribute to the development of ICH Common Technical Documents (CTDs).
- Develop and continuously improve on an understanding of the FDA NDA and ANDA processes.
- Business Development
o Provide scientific and clinical perspective to matrix teams in the development and execution of business development
opportunities which support overall strategic and business objectives.
o Provision of education to potential project teams regarding clinical or scientific background for proposed projects.
o Participation in administrative activities as required by the Vice President/Chief Medical Officer in order to maintain
business standards in compliance with SOPs and local guidelines.
Education Requirements and Qualifications
- Bachelor’s degree in clinical, scientific or related field required
- Pharmaceutical industry experience, a plus.
- Excellent oral and written English communication skills.
- Experience as direct clinical or scientific liaison with the US Food and Drug Administration is desired but not required.
- Ability to work well in a matrix environment, particularly with Project Management, Regulatory Affairs, CMC, Business Development and Medical Affairs.
- Software: MS Office with emphasis on Word, Excel, Power Point, project management software (e.g. MS Project).
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.