Clinical Portfolio Strategy – HR046

Location: Bridgewater, NJ

Company Description
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.

Position Summary

  • Identifying potential product concepts for pipeline in the clinical unmet space that aligns with Nevakar’s strategy. This will require systematic exploration and evaluation of repositioning existing drugs for new indications.  This effort may also require building cross functional collaboration within as well as outside Nevakar.
  • Lead and provide a high level of business decision and analytical support for commercial Development through effective data driven decision making, ensure market relevance & finalized TPP.
  • Develop forecast models based on key assumptions and in collaboration with other cross functional teams who input data and/or assumptions into the forecast.
  • Prioritization of pipeline and potential pipeline products based on value proposition from clinical innovation perspective.
  • Interact with therapeutic area specific KOL’s for in-depth assessment on specific concept and therapeutic area.
  • Clinical literature assessment and in-depth analysis to provide thorough clinical justification for the concept development.
  • Work with cross functional teams to understand the development, operational and clinical study needed for the concept that can be in cooperated into the business case.
  • Synthesize and integrate various data, research, and analysis to generate holistic and impactful insights.
  • Lead market research and analytics for potential in-licensing & internal pipeline products.
  • Lead the Competitive Intelligence directive at Nevakar and monitor activities of the pharmaceutical industry with the objective of identifying potential threats for Nevakar pipeline assets.
  • Identify timely and relevant market and competitive insights, assesses market trends and develop deep insights into opportunities and threats.
  • Provide analysis & support and make well-informed recommendations to optimize Nevakar’s positioning with investors community.
  • Assist with budget for all activities for the business unit.
  • Assist in creating business plan and development of presentations for investors.
  • Provides strategic intelligence to support decision making by utilizing personal professional (scientific and commercial) acumen with primary (professional networks; contract resources) and secondary (publications, electronic databases) sources of information.

Qualifications

  • Required: PharmD, PhD
  • Preferred: MD

Technical Skills

  • Sold proficiency and knowledge of commonly used pharmaceutical industry databases like IMS data, Symphony, etc.
  • Patent database search
  • PowerPoint and excel
  • Use of various CI portals

Experience

  • 10 plus years working in pharmaceutical or medical space in injectable and ophthalmic space and experience in leading portfolio strategy, specifically in drug repositioning
  • Understanding of the 505B2 regulatory pathway for injectable and ophthalmic drug products
  • Clinical and therapeutic area assessment
  • Demonstrated analytical skills—should understand the advantages and limits of different analytical approaches and studies and their findings
  • Lead and execute clinical market research activities
  • Deep understanding of marketing and business analysis concepts
  • Excellent oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences
  • Demonstrated ability to think strategically to support key business decisions
  • Ability to work collaboratively in team-based environment
  • Strong ability to quickly understand the latest developments in the pharmaceutical industry, and unmet medical needs and opportunities
  • Proficient facilitation, problem-solving and conflict resolution skills
  • Previous experience with product launches (preparation and tracking) preferred