Novartis

Clinical Development Director – Cardiovascular, Metabolic

Novartis

full-time

Posted on:

Location Type: Office

Location: Dublin • Ireland

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program.
  • Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
  • Leading development of clinical sections of trial and program level regulatory documents
  • Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable
  • Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
  • Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety
  • As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
  • Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training and may be the Program Manager of other associates.

Requirements

  • Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred
  • Fluent oral and written English
  • Minimum 5 for CDD and 7 years experience for Snr CDD experience in clinical research or drug development
  • Working knowledge of the assigned disease area (Cardiovascular/Metabolic) 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 key investigators
  • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
  • Strong communication skills with the ability to work in a cross functional and global organization.
Benefits
  • Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchdrug developmentclinical trial designGCPstatisticsregulatory processesclinical data reviewsafety reportingscientific trainingprotocol development
Soft Skills
leadershipcommunicationinterpersonal skillscollaborationrelationship buildingstrategic thinkingpresentation skillscross-functional teamworkstakeholder engagementscientific expertise
Certifications
PharmDPhD