Responsible for providing support with regard to all aspects of Clinical Pharmacology including study planning, Pharmacokinetic (PK) analysis, and reporting for early and late stage clinical development plans in accordance to appropriate regulatory guidelines. Work with the regulatory team, project managers, data managers, biostatisticians, and other clinical research specialists to ensure accurate execution of research protocols in agreement with good scientific and clinical research practices, and in compliance with Noven standard operating procedures (SOPs) and other company procedures. Review methodologies and data collection, perform analyses, interpret findings, and write reports for submission to the U.S. Food and Drug Administration (FDA).
Assignment to the various levels is approved by Corporate Compensation and is based on the required knowledge in the field of work, years of experience, on-going responsibility for highly complex assignments, significance of the scope of responsibility, and the job function's considerable impact within the department and the company, as well as the reporting relationship and required supervisory responsibility.
Interact closely with internal team members, Contract Research Organization’s (CROs), partner organization scientists, and Noven management.
Design clinical pharmacology studies across stages of development. Perform non-compartmental and compartmental analysis of clinical data, as appropriate, and provide interpretation of PK and PK/PD results. Experience with WinNonlin is required.
Apply and interpret modeling and simulation approaches, including clinical trial simulations that will support study design and dose selection. Maximize the use of predictive tools for a more efficient and leaner clinical drug development. Experience with NONMEM/R and Monolix/SimCyp is preferred but not required.
Make major contributions to the clinical pharmacology and pharmacometrics strategy to meet corporate, scientific and regulatory needs as a member of appropriate project teams
Consistently mine scientific literature and information from scientific meetings to bring innovation into clinical trial study design and gather insights for life cycle management indications of existing molecules.
Prepare regulatory documents, including reports, protocols, investigator brochures, FDA communications, presentations, abstracts and other scientific documents. Provide clinical pharmacology support in response to regulatory agencies questions as needed.
Assist in the evaluation of compounds proposed for incorporation into transdermal systems. Experience in developing transdermal formulations is preferred but not required.
Able to effectively communicate (written and verbal) complex ClinPharm-related concepts and topics to fellow SMEs and other functions.
Proactive in problem-solving and in finding creative solutions
Enjoy team work in a collaborative and fast-paced environment
Education & Experience:
PhD in pharmaceutical sciences / pharmacokinetics or related field (M.D. a plus) and
8 or more years of professional experience in the pharmaceutical industry in a clinical R & D organization
2 years management experience. Knowledge of the Code of Federal Regulations (CFR), International Conference on Harmonisation (ICH), and Food and Drug Administration (FDA) regulations and guidance is a must.
Internal Number: 0014
About Noven Pharmaceuticals
Noven Pharmaceuticals, Inc. is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. We are committed to developing and offering pharmaceutical products that meaningfully benefit patients, with a commitment to advancing patient care through transdermal drug delivery.Over 325 Noven colleagues are working to advance our business and benefit patients at locations in Miami, FL and Jersey City, NJ. We are a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., the world’s largest manufacturer of transdermal patches, and we serve as Hisamitsu's platform for U.S. prescription pharmaceuticals, helping Hisamitsu bring the benefits of patch therapy to the world.Noven CoaterNoven maintains state-of-the art, FDA-approved transdermal manufacturing facilities in Miami with capacity to produce several hundred million patches per year. These facilities are also approved by the U.S. DEA (Drug Enforcement Agency) for the production of controlled substances.Noven’s commercialized transdermal products include Minivelle® (estradiol transdermal system), the planet’s smallest estrogen patch; Combi...Patch® (estradiol/norethindrone acetate transdermal system), the first approved combination (two-drug) patch; Daytrana® (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD. Noven's commercialized products are marketed through Noven Therapeutics, LLC. Noven's authorized generic division, Grove Pharmaceuticals, offers our products to the generic marketplace as Authorized Generics.Minivelle PatchNoven’s product development pipeline includes a range of prescription transdermal products that utilize Noven’s advanced transdermal delivery technology.