Location: London, United Kingdom or Dublin, Ireland
Role Purpose:
The Associate Clinical Development Director (Assoc. CDD) in Neurosciences provides input to development of protocols for assigned global clinical trials, scientific monitoring, and reporting of quality data. May be assigned to provide support to development of the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity
About the Role
Major accountabilities:
Provides input to the development of clinical development strategy , 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 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)
In collaboration with appropriate Clinical Trial Team (CTT) members:
a)Ensures clinical development oversight and support of trials as needed
b)Conducts ongoing scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead/CDMD/CSL
c)Manages 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/CDMD/CSL in collaboration with patient safety
d)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 line function initiatives)
May be assigned to lead clinical trial(s) 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 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
Supports TA 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) is required. PharmD, or PhD strongly preferred
Neurology, Experience in Cell & Gene, Rare or Neuromuscular diseases, Neuroinflammation, Neurodegeneration, Experience in MS or related (strongly preferred)
Languages: Fluent oral and written English
Experience/Professional requirement:
+ 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 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
Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
Demonstrated ability to establish effective working relationship with stakeholders
Working knowledge of ICH, GCP, clinical trial design and methodology, statistics, and regulatory and clinical development processes
Strong communication skills, written and oral
Strong interpersonal skills
Strong negotiation and conflict resolution skills
People management 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:
https://www.novartis.com/careers/benefits-rewards
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards:
Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Universal Hierarchy Node
Location
United Kingdom
Site
London (The Westworks)
Company / Legal Entity
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
Alternative Location 1
Dublin (Country President Office (CPO)), Ireland
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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