A small, growing pharmaceutical company is seeking a GCP/GLP Quality Director to join them at their office in Bridgewater, New Jersey. The company is a specialty injectable pharma company that strives to develop innovative therapies to tackle unmet medical need in the world.
- Identifying potential product concepts for pipeline that aligns with the company's strategy.
- 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.
- 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 the company and monitor activities of the pharmaceutical industry with the objective of identifying potential threats for the company 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 company positioning with investors community.
- Assist with budget for all Commercial activities.
- Lead efforts on the vendor selection and secondary data purchases for the commercial group.
- Assist to create 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.
Education and Experience:
- Science educational background like Pharm D or in medicine preferred.
- 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
- 8 plus years working in pharmaceutical space in injectable and ophthalmic space in areas of portfolio management and marketing
- Understands the 505B2 injectable space
- Demonstrated analytical skills-understands the advantages and limits of different analytical approaches and studies and their findings
- Lead and executed 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
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please send your CV to Hannah Cihlar on [click here] or upload on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.