Associate Clinical Development Director – Neurology at Novartis, Apply Now!
Looking to make a global impact in clinical research? Novartis is hiring an Associate Clinical Development Director (Neurology) to lead and shape groundbreaking clinical trials. This role offers the opportunity to drive strategy, contribute to regulatory documents, and collaborate with cross-functional teams—all while advancing treatments in the neuroscience domain. Discover how your clinical expertise can contribute to life-changing therapies at one of the world’s top pharmaceutical companies.
About the Role
Major Accountabilities:
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Provides input to the development of clinical development strategy and contributes to trial-related documents (e.g., CTPs, informed consent forms, case report forms, data monitoring committee charters, data analysis plans, reports, and publications) for assigned clinical trial(s), aligned with the Clinical Development Plan (CDP). Develops materials for advisory boards, data monitoring committees, investigator meetings, and training meetings for Novartis’ local clinical development teams.
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Offers clinical and scientific input and contributes to clinical sections of regulatory documents, including Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and Health Authority responses.
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In collaboration with Clinical Trial Team (CTT) members:
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Ensures development oversight and trial support.
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Conducts scientific reviews of trial data with Clinical Scientific Expert(s) under Medical Lead/CDMD/CSL supervision.
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Manages patient safety reporting to safety and clinical boards (SMT, GCT, GPT) with appropriate oversight.
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Provides input on final analyses and interpretation, supporting Clinical Study Reports (CSRs), publications, and presentations.
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Contributes to global initiatives such as process improvements, training, SOP development, and other Clinical Development line function initiatives.
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May lead clinical trial(s) as a Clinical Scientific Lead, offering leadership and guidance across clinical aspects in collaboration with medical monitors and/or CDMD.
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Responsible for planning, execution, and implementation of operational strategy.
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Develops materials for advisory boards, committees, and training meetings.
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Supports medical input into IDP and CTP reviews, and contributes to disease clinical standards.
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Contributes to talent development through onboarding, mentoring, and coaching.
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Ensures timely reporting of technical complaints/adverse events within 24 hours and manages marketing sample distribution as needed.
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Key Performance Indicators:
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Delivers high-quality clinical and strategic input with timely, high-standard CTPs and deliverables.
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Applies advanced research methodology for trial design, efficacy endpoints, and safety assessments.
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Contributes to CDP and protocol reviews with impactful support.
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Supports development of clinical standards, publications, and presentations.
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Provides quality input for regulatory documents, Investigator’s Brochures, safety updates, and dossiers.
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Ensures efficient trial execution within budget and quality standards, with effective risk and contingency planning.
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Demonstrates cost-effective resource and budget management.
For CSE Group Heads:
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Strong leadership to build team capabilities and lead global initiatives.
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Timely delivery of program activities with proactive risk communication.
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Demonstrates Novartis Values: Innovation, Quality, Collaboration, Performance, Courage, and Integrity.
Experience:
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≥3 years in clinical research or drug development (Phases I–IV).
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≥2 years in clinical trial execution and reporting in a matrixed, global pharmaceutical environment.
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Working knowledge of neurology or related disease areas preferred.
Education:
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Advanced degree in life sciences or healthcare is required.
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PharmD or PhD strongly preferred.
Skills & Competencies:
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Clinical trial design, ICH, GCP knowledge.
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Strong data analysis and communication skills.
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Team leadership, stakeholder engagement, conflict resolution.
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Experience in budget and risk management.
Languages:
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English (required)
Keywords: Associate Clinical Development Director, Neurology, Novartis, Clinical Research, Clinical Trial Protocol, Pharmaceutical Industry