Associate Clinical Development Director

Associate Clinical Development Director (VHB) – Novartis Ireland

Location: London, United Kingdom or Dublin, Ireland

Overview

The Associate Clinical Development Director (Assoc. CDD) in Neurosciences provides input to the development of protocols for assigned global clinical trials, scientific monitoring, and reporting of quality data. May be assigned to support the development of the clinical and scientific strategy of assigned sections of a clinical development program, depending on size and complexity.

Responsibilities

• Provides input to the development of clinical development strategy and contributes to trial-related documents (e.g., Clinical Trial Protocols, informed consent forms, case report forms, data monitoring committee charters, data analysis plans, reports, publications) for assigned clinical trials, consistent with the Clinical Development Plan (CDP); develops materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings for Novartis local clinical development teams.
• Provides clinical 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).
• Collaborates with appropriate Clinical Trial Team (CTT) members to ensure clinical development oversight and support of trials as needed.
• Conducts ongoing scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead/CDMD/CSL.
• Manages patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team, GCT, GPT) with appropriate oversight from Medical Lead/CDMD/CSL in collaboration with patient safety.
• Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations, with appropriate oversight from Medical Lead/CDMD/CSL.
• Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development initiatives).
• May be assigned to lead a clinical trial as Clinical Scientific Lead and provide leadership and guidance for all clinical aspects of a clinical trial in close collaboration with the assigned medical monitor and/or CDMD.
• Evidence of quality clinical and scientific strategic input as well as timely delivery of high-quality CDP documents and other clinical deliverables.
• Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease areas and development phases.
• Supports therapeutic area through high-quality contributions to CDP 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 Brochures, briefing books, safety updates and submission dossiers.
• Clearly demonstrates Novartis Values and Behaviors.

Minimum Requirements

• Education (minimum/desirable): Advanced degree in life sciences/healthcare (or clinically relevant degree) required. PharmD or PhD strongly preferred. Neurology, Cell & Gene, Rare or Neuromuscular diseases, Neuroinflammation, Neurodegeneration; experience in MS or related areas strongly preferred.
• Languages: Fluent written and spoken English.
• Experience/Professional Requirement: ≥ 3 years of involvement in clinical research or drug development in an academic or industry environment spanning Phases I–IV; ≥ 2 years of contribution to all aspects of conducting clinical trials (planning, execution, reporting, and publishing) in a global/matrix pharmaceutical setting.
• Working knowledge of the assigned disease area with the ability to interpret, discuss, and present efficacy and safety data.
• Proven ability to establish effective working relationships with stakeholders.
• Working knowledge of ICH, GCP, trial design/methodology, statistics, and regulatory and clinical development processes.
• Strong written and oral communication skills and strong interpersonal skills.
• Strong negotiation and conflict resolution skills.
• People management experience is preferred.

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Benefits And Rewards

Read our handbook to learn about all the ways we'll help you thrive personally and professionally.

Position Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analyst, and Information Technology
• Industries: Pharmaceutical Manufacturing

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