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.
Post : Sr. Clinical Research Scientist
Job Description
Job Summary/Objective
The Clinical Scientist will functionally report to Clinical Lead, and help drive the development of one or more molecules from pre-phase 1 through global registration. In this role the Clinical Scientist, in conjunction with the Clinical Lead, will provide guidance and leadership to the broader project teams.
Essential Functions
• Contribute to the compound’s development strategy and assisting with Protocol design. As such, contributing to the writing of clinical development plan, clinical studies, etc., as appropriate
• Provide scientific and clinical expertise in the development and writing of Clinical Protocols and clinical development plans that strive to achieve the target product profile. This may include identifying and reaching out to KOLs, as well as organizing and leading meetings with external experts to obtain guidance on study designs, as appropriate
• Contribute to the clinical and scientific background sections of various documents, including Protocols (as described above), Investigator’s Brochures, INDs, CTAs, Study Reports, Clinical Summaries, Clinical Overviews, and other documents, as appropriate
• The Clinical Research Scientist will review SAE reports, AE and SAE listings, AE coding, concomitant medication coding, medical history coding, tables and listings of safety and efficacy data, and other output from clinical studies. The Clinical Research Scientist may perform data assessment and take on a leadership role in this area, as appropriate
• Participate as a Clinical Trial Team (CTT) member, as appropriate. Function as Project Clinician in the CTT setting with medical/clinical support from a Clinical Lead. In this role the Clinical Research Scientist will work closely across functions (e.g., Preclinical, CMC, Clinical Operations, Biostatistics, Regulatory, Clinical Pharmacology, Data Management, Safety/Pharmacovigilance etc.…) to ensure the effective and efficient conduct of clinical studies to milestones, quality and budgets.
• Participate in the Clinical Sub-team meetings, and assist the Clinical Lead in carrying out their role as leader of the Clinical Sub-team, including delegation by the Clinical Lead to lead the meeting when appropriate
• Participate in Pharmacovigilance Signaling Meetings and Safety Working Group meetings, as appropriate
• Participate in or lead regularly scheduled and ad hoc teleconferences and meetings with clinical investigators, as appropriate. Participate in and contribute clinical insights and interpretations on routine calls for Phase 1, 2, 3 studies where study design, data review (safety and efficacy) are reviewed.
• As appropriate, work closely with Investigators and other site personnel, in partnership with other Development functions, such as Clinical Operations and Pharmacovigilance, in order to facilitate the efficient startup, conduct and close-out of clinical trials, and to answer questions from investigators and other site personnel regarding clinical and study conduct questions. In this capacity the Clinical Scientist will help ensure patient safety, maintain appropriate adherence to the Protocol, and evaluate Protocol exception requests. For Investigator Meetings and startup of individual studies, the Clinical Scientist may independently develop Protocol-specific materials and lead internal or external training, as appropriate
• In conjunction with business development and clinical staff, review external co-development and in-licensing opportunities. The Clinical Scientist may participate in and present analyses from these reviews, as appropriate
• Support the Clinical Lead in responding to requests from Regulatory Authorities
• When appropriate, identify, promote, and lead improvement initiatives
• Assists in a seamless transition from preclinical to exploratory development or from exploratory development to late-stage development Competencies
Candidate Profile
- PhD, PharmD, BS, MS or comparable degree, may be sufficient in the setting of significant experience performing a similar Clinical Research Scientist role in a clinical research group
- Minimum 4 years clinical research experience in an industry setting, with experience in clinical research, particularly in the areas of Protocol development, study conduct, and data review
- Track record of achievement and innovation in pharmaceutical medicine
- Understanding of issues related to the design and performance of technologically demanding trials.
- Confident discussing scientific/mechanistic aspects of drug development
- Track record of partnering with clinical leaders in designing excellent clinical studies and demonstrated potential to design
- Development plans that produce both timely and good quality data
Additional Information :
Experience : 4 years
Qualification : PhD, PharmD, BS, MS
Location : Jersey City, NJ 07310 US (Primary)
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Research/Regulatory Affairs
End Date : 15th April, 2018
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