Associate Clinical Development Medical Director

Novartis Pharmaceuticals East Hanover , NJ 07936

Posted 7 days 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


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.
Download the
LiveCareer app and find
your dream job anywhere
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
Associate Director Oncology Medical Affairs Compliance & Governance
New!

Novartis Pharmaceuticals

Posted Today

VIEW JOBS 11/16/2018 12:00:00 AM 2019-02-14T00:00 Job Description The OMA Compliance & Governance GxP Senior Manager / Associate Director is responsible for driving and implementing an integrated Global, Regional and Local Compliance strategy to ensure adequate oversight and monitoring of Oncology Medical Affairs clinical trials including Pharmacovigilance activities as applicable (GxPs). Within this role, he/she will ensure leadership, on-going support and guidance to the Global clinical operations franchise team, Regional and Country compliance champions within the organization to drive compliance with applicable regulatory requirements, the Novartis Quality Management System, policies & written procedures as well as implementation of Industry Best Practices, in collaboration with Global Governance and Pharma Medical Affairs as appropriate. The position holder will contribute to the OMA organization as a member of the Compliance & Governance team to ensure consistency and deliver key strategic priorities, objectives and goals within their respective area of responsibility at Global, Regional and Local level. He / she will also be a member of the Compliance Governance Forum by leading oversight and monitoring of GxP landscape. Key Accountabilities 1.Responsible for an effective global, regional and local implementation and improvement of the Novartis Quality Management System for Clinical Trials including Pharmacovigilance activities as applicable. 2.Provides leadership and direction to the Compliance team (global clinical operations franchise team, region and countries) for an adequate oversight and monitoring of clinical trials activities. 3.Provides input to the global clinical operations franchise team, the region and countries decision-making, prioritization of initiatives and drive consistent rollout of global initiatives related to oncology medical affairs compliance. 4.Defines and monitors global franchise clinical operations team, regional and local quality objectives in alignment with Oncology Medical Affairs global strategy and Novartis Global Quality Plan. 5.Provides expert advice and operational support and guidance to the global franchise clinical operations team, region and CPOs, performs regular country visits and runs regular one to one interactions with global, region and local champions. 6.Drives and executes change management to promote a sustainable culture and mindset of high ethical standards and compliance through quality across the global franchise clinical operations, region and CPOs and embed it into daily work. 7.Identifies opportunities to foster alignment and ownership / accountability of compliance at global, regional and local level. 8.Builds at global, regional and across countries compliance networks that allows knowledge sharing and knowledge transfer as a basis for improving compliance performance. 9.Provides actionable data to the Global Head Compliance & Governance on the state of medical compliance for his / her global franchise clinical operations team, region and countries to minimize compliance risk. 10.Oversees the management of the compliance dashboard framework & its business process for the global, regional CPOs organization, and reports areas for improvement to the Compliance & Governance Forum. 11.Ensures regular review and assessment of key performance / quality indicators at the global, regional and local level and across GxP processes. 12.Ensures that global regulated processes are adequately rolled out, trained and implemented in the global franchise team, the region and countries. 13.Serves a member of the Compliance & Governance Forum chaired by the Global Head Compliance and Governance. 14.Ensures that global, regional and country GxP medical compliance gaps and risks are addressed and mitigated. 15.Maintains global, regional and local quality oversight and monitoring of the Deviation & CAPA Management process for GXP processes & related activities at global, regional and local level. 16.Supports global franchise clinical operations team, regional and local champions in the development of robust CAPAs arising from self-identified deviations, affiliate audits and inspections. 17.Maintains oversight that CAPAs are appropriately documented, tracked, monitored and followed up to timely and effective closure. 18.Ensures that action is taken for CAPAs at risk of becoming overdue or ineffective. Employment Type Regular Novartis Pharmaceuticals East Hanover NJ

Associate Clinical Development Medical Director

Novartis Pharmaceuticals