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NPS Pharmaceuticals 1 reviews– Bedminster, NJ
NPS Pharmaceuticals - 30+ days ago
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) is a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide. The companys lead product, Gattex® 0.05 mg/kg/d (Teduglutide [rDNA origin]) for Injection for subcutaneous use is FDA-approved for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. NPS is also developing Natpara® (rhPTH[1-84]) for the treatment of adult hypoparathyroidism and expects to submit its Biologic License Application (BLA) to the FDA in mid-2013. NPS's earlier stage pipeline includes two calcilytic compounds, NPSP790 and NPSP795, with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH). NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates.
The Director, Epidemiology will be responsible for developing, coordinating, and executing epidemiology research, including oversight for NPS registries and comparative safety databases, for product support from early development through full life cycle management. The Director, Epidemiology will provide guidance and direction to project teams, safety management team, the Executive Team, and other colleagues to ensure effective management of high-impact cross-functional project opportunities and risks. She/he will ensure scientific quality and timely, cost-effective project delivery while adhering to NPS core values and responding to business needs. The incumbent must be highly innovative, proactive and collaborative on teams across the organization. The Director, Epidemiology must have a broad view of the role of epidemiology and pharmacoepidemiology in industry from target identification through drug development. She/he must be able to provide reports on value demonstration, market access, and effectiveness and safety. Also, the Sr. Director Epidemiology will interact with a wide range of internal and external customers to ensure appropriate communication of epidemiological issues and study results. The incumbent will also be responsible for epidemiological support for interactions with regulatory authorities.
Ph.D. in epidemiology or a related field, or an MD with a Masters degree in epidemiology, minimum of 5 years experience as an epidemiologist in the biotech/pharmaceutical industry. Or a Masters degree or equivalent and at least 10 years experience as an epidemiologist in the biotech/pharmaceutical industry.
Deep technical knowledge, extensive industry experience, and an established professional network within the pharmacoepidemiology community
Proven results in epidemiological research with qualified results in successful design, execution, and publication of epidemiological research. Extensive collaboration experience with external investigators, as well as recognition by the external scientific communities as an expert in areas relevant to drug development, pharmacovigilance, and commercialization, from early development through life cycle management
Specialized knowledge, Licenses, etc.:
Experience with GI/Endocrine, orphan drugs, comparative effectiveness research, direct interaction with regulatory authorities, patient risk management program evaluation, business development due diligence, and/or international market access issues