Associate Clinical Development Medical Director

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 3 months ago

Job Description:

The Associate Clinical Development Medical Director (Assoc. CDMD) is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity.
1)Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations 2)Provides medical and scientific input and contributes to clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities) 3)In collaboration with appropropriate Clinical Trial Team (CTT) members: a)Ensures direct medical support of trials as needed and may act as medical monitor b)Conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s) c)Manages patient safety and reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) d)Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations 4)Under the direction of the (Sr.) GPCH or (Sr.) CDMD, contributes to ensuring overall safety of the compound for assigned trial(s) in collaboration with Patient Safety 5)Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs 6)Supports development of TA strategies, as needed 7)May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities 8)Contributes to talent and career development of CD associates through on- boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members 9)Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training 10)Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

Evidence of quality medical and scientific strategic input as well as timely delivery of high quality CTPs and other clinical deliverables Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases Evidence of quality medical and scientific review of clinical trial data, development of CSRs Supports TA through high quality contributions to IDP and protocol reviews Supports timely development of quality disease/program clinical standards, publications, and internal/external presentations Evidence of quality contributions to clinical sections of regulatory documents, Investigator's Brouchures, briefing books, safety udpates and submission dossiers Clearly demonstrates Novartis Values and Behaviors

Employment Type

Regular


upload resume icon
See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Development Medical Director Ophthalmology

Novartis Pharmaceuticals

Posted 2 weeks ago

VIEW JOBS 1/4/2019 12:00:00 AM 2019-04-04T00:00 Job Description Clinical Development Medical Director Ophthalmology 38 Million! 38 million Americans over age 40 currently have low vision, an age-related eye disease, or are blind—this is expected to increase to 50 million by 2020. At Novartis, we strive to develop therapies that will halt - or even reverse – the ocular damage and degeneration that eventually leads to blindness. Be part of a team that brings life changing medicine to patients affected by eye disease. The Clinical Development Medical Director Ophthalmology will provide medical leadership and expertise to ophthalmology clinical trials executed in US. Novartis is currently recruiting for a Clinical Development Medical Director Ophthalmology to provide medical affairs, clinical drug development and strategic, cross-functional leadership to effectively shape, influence, develop and drive strategies and medical plans that ensure maximal regulatory, reimbursement and commercial success of early development compounds (proof of concept – Phase 3b) in the US. This position will be located in East Hanover, NJ and will be filled at a level commensurate with experience. A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. It is a pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of this makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage. The Clinical Development Medical Director Ophthalmology will partner proactively and effectively with leaders across commercial, US Medical Affairs, global (Clinical development, Global Medical Affairs, and Global Clinical and Brand Teams) and Novartis Institute for Biomedical Research (NIBR), leveraging strong technical/medical expertise, business/market acumen and a comprehensive understanding of business strategy, to develop strategies and medical plans that ensure maximal regulatory, reimbursement and commercial success of compounds in the US. Additional responsibilities include the following: * Provide strategic US Medical input to Global Development on clinical development programs (Phase POC-Phase 3b) * Partner with global and US clinical, medical and commercial teams to ensure that registration programs are rigorous and that outputs meet specific US needs * Ensure program strategy, value story and value proposition are evidence-based and consistent with US treatment practices * Lead the generation of early development strategies and tactical plans that support US commercial, reimbursement and regulatory success * Provide scientifically and clinically sound guidance for BD&L evaluations * Identify gaps in registration programs and lead the design and execution of Phase 3b studies to address US-specific gaps * Develop and enhance relationships with diverse external stakeholders through congress participation and leadership of scientific/medical exchanges * Rapidly develop/enhance credibility with NIBR with a focus on enhancing LPT understanding of pipeline * Manage work across a matrix organization and influence without authority * Ensure customer perspective is fully integrated into all LPT deliverables * Brief all levels of management on key topics and leverage their support for LPT success Employment Type Regular Novartis Pharmaceuticals East Hanover NJ

Associate Clinical Development Medical Director

Novartis Pharmaceuticals