Clinical Project Physician – HR051
Location: Bridgewater, NJ
Nevakar is a privately-held, specialty pharmaceutical company committed to developing innovative products in the injectable and ophthalmic space. The company is dedicated to the development of enhanced products that address unmet clinical and/or commercial needs of current FDA approved molecules, through intensive R&D and clinical efforts.
Nevakar’s drug repositioning efforts are focused on the design and development of 1) improved formulation, 2) functional packaging, 3) novel drug delivery approaches, and 4) regulatory and clinical strategies. Resulting new and repositioned products are expected to provide patient-centric benefits while ensuring incremental value proposition for the healthcare system. These new products with proprietary enhancements are filed with the FDA, primarily under the 505(b)(2) regulatory pathway.
The Clinical Project Physician provides direction and input for the clinical/medical aspects of clinical drug development program. Responsible for design, development and execution of clinical trials and protocols and other clinical development activities in accordance with applicable GCP regulations. May be asked for medical input/participation (e.g., study cross coverage) on other programs as well on an as needed basis. May contribute to, the documentation analysis and dissemination of study results. Assesses the extent to which the study (ies) has achieved clinical, regulatory and commercial objectives. The incumbent works cross functionally with internal departments and external resources on Clinical related issues.
- Represents the clinical study team at cross-functional, integrated team meetings as the medical expert
- Contributes to, reviews and approves study protocols, protocol amendments, study manuals, and other clinical documents as required for the conduct of clinical trials and in compliance with GCP.
- Provides medical oversight including medical monitoring responsibilities of clinical trials.
- In collaboration with the clinical operations, develops and manages budgets, negotiates and monitors contracts and oversees expenditures to ensure the timely and cost-effective implementation of clinical trials.
- Approves, monitors and adheres to clinical study timelines.
- Leads and/or contributes to the vendor selection process; manages relationship with external vendors, partners, investigators and key opinion leaders. Serves as a primary point of contact for PI site and Pi’s of clinical trials.
- Approves investigator sites for inclusion in study(ies); helps plan and facilitate investigator meetings and presents selected sections of the agenda/content.
- Ensures adherence to appropriate regulations, SOPs and company policies and practices.
- Provides clinical/medical input to commercial functions as requested.
- Interacts with Health Authorities including, but not limited to, the FDA, and EMA, as needed.
- An MD degree and a minimum of 4 years of clinical trial experience with experience in pediatrics and/or ophthalmology (at least 2 of which are within a clinical development team) in an academic, pharmaceutical, biotechnology or related environment.
- Ideal candidate would demonstrate experience managing one or more global clinical programs within mid to late phase regulatory processes.
- Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
- Previous experience with regulatory submissions is ideal.
- Ability to influence without direct authority in a matrixed environment
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent written, verbal, and interpersonal communication skills
- Equal Opportunity Employer Minorities/Women/Veterans/Disabled