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Novartis · 3 months ago

(Associate) Clinical Development Director

East Hanover

Full-time

Hybrid

Senior Level

$153K/yr - $283K/yr

5+ years exp

Novartis Pharmaceuticals Corporation is seeking a Clinical Development Director in Cardiology to oversee the scientific and clinical strategy of assigned clinical trials. This role involves providing clinical leadership, contributing to trial-related documents, and ensuring regulatory compliance while supporting the development of talent within the team.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Responsibilities

Provide clinical leadership, medical and scientific strategic input, and contribute 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); develop materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations

Provide clinical and scientific input and contribute 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)

In collaboration with appropriate Clinical Trial Team (CTT) members: Ensure clinical support of trials as needed; conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead; manage patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead; provide input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations

Support Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs, and support development of TA strategies, as needed

May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities

Contribute to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develop and foster CD culture; and may contribute to the performance evaluation of CTT members

Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training

Contribute to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

Qualification

Clinical ResearchClinical TrialsData AnalysisClinical Trial ProtocolGCPDrug DevelopmentCoachingLearning DesignLifesciencesRisk ManagementRisk MonitoringCross-Functional Teams

Required

Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required

5+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV; 2 or more years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g. planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry

Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level

Working knowledge of the disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level

Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes