Associate Clinical Development Director

London - UK

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

LOCATION: London Dublin Barcelona
ROLE TYPE: Hybrid Working #LI-Hybrid

The Associate Clinical Development Director (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:

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. Investigators Brochures Health Authority briefing books safety updates submission dossiers and responses to Health Authorities)
In collaboration with appropriate Clinical Trial Team (CTT) members:
Ensures 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 (SMT) 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 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.

Education

Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. PharmD or PhD 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 and Inclusion:

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

#LI-hybrid

Skills Desired

Budget Management Clinical Research Clinical Trial Protocol Clinical Trials Coaching Data Analysis Data Integrity Learning Design Lifesciences Risk Monitoring Trends Analysis

Required Experience:

Director

Job Description SummaryLOCATION: London Dublin Barcelona ROLE TYPE: Hybrid Working #LI-HybridThe Associate Clinical Development Director (Assoc. CDD) provides input to development of protocols for assigned global clinical trials scientific monitoring and reporting of quality data. May be assigned to...