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Associate Clinical Development Director (Oncology)

Novartis
Full time
2 days ago

Band

Level 5


 

Job Description Summary

LOCATION: Dublin. London, Basel or Barcelona
ROLE TYPE: Hybrid Working, #LI-Hybrid

The Associate Clinical Development Director (Oncology)  (Assoc. CDD) 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.


 

Job Description

Major accountabilities:

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 (ML)/ Clinical Development Medical Director (CDMD)/ Clinical Science Liaison (CSL)

c) Manages patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), Global Clinical Trials (GCT), Generative Pre-trained Transformer (GPT)) with appropriate oversight from ML/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 ML/CDMD/CSL

Key Performance Indicators:

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

Work Experience:

Why Novartis?:

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You’ll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion:

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

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network


 

Skills Desired

Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring
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