Clinical Development Director (MS/MG)
Clinical Development Director (MS/MG)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description Summary
The Clinical Development Director (CDD) Neuroscience and Gene Therapy is the clinical/scientific and clinical development expert and provides leadership and support to clinical development deliverables and activities within a defined global clinical development program and/or global clinical trial (e.g. clinical development plan clinical trial protocol) under the leadership of the GPCH.Job Description
Major accountabilities:
Supports and if assigned leads delivery of all assigned clinical deliverables in the assignedsection of a clinical program. Clinical deliverables may include the clinical development strategyfor assigned program section(s) clinical sections of individual protocols consistent with theIntegrated Development Plans (IDP) clinical data review and program specific standardsclinical components of regulatory documents/registration dossiers and publications
Provides input into final analyses and interpretation including the development of the ClinicalStudy Report(s) (CSRs) publications and internal/external presentations.
Leads development of clinical sections of trial and program level regulatory documents ( Brochures briefing books safety updates submission dossiers and responses toHealth Authorities)
Oversees/conducts ongoing clinical and scientific review of clinical trial data with medicalmonitor Clinical Scientific Expert(s) with appropriate oversight from Medical Lead. Work in closecollaboration with the data management and statistics teams to ensure proper data quality andanalysis of clinical trial results.
Inspection Readiness and interaction with QA - risk assessments audit preparation mockinterviews storyboard and presentation prep; Author and/or review abstracts presentations andmanuscripts for accuracy of clinical data and content
Provides support to Sr CDMD and/or GPCH in monitoring and safety data and signals the moleculefor the assigned section of the clinical trial may be a member of the Safety Management Team(SMT) and supports overall program safety reporting (e.g. Periodic Safety Update Reports (PSURs)Drug Safety Update Reports (DSURs) and other safety related documents) in collaboration with themedical monitor CDMD and Patient Safety
As a clinical development expert may support the GPCH or CDH in interactions with externalstakeholders (e.g. regulatory authorities key opinion leaders data monitoring boards advisoryboards patient advocacy groups) internal stakeholders (e.g. CTT Research TranslationalMedicine Global Medical Affairs Marketing HE&OR) and internal decision boards
May work with Biomedical Research/Translational Medical Sciences) to drive transition of pre-PoC(Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development& Licensing) including target identification and due diligences together with other medicalmatters as assigned
Ensures career development of Program reports and other clinical colleagues through activeparticipation in the performance management and talent planning processes. Provides on-boardingtraining & mentoring support
Contributes to medical/scientific training of relevant Novartis stakeholders on the diseasearea and compound/molecule. May serve as speaker for franchise medical/scientific training
May serve on or lead global initiatives (e.g. process improvement training SOP developmentother Clinical Development line function initiatives)
May be assigned to lead clinical trial(s) as Clinical Scientific Lead and provide leadershipand guidance for all clinical aspects of a clinical trial in close collaboration with the assignedmedical monitor and/or CDMD.
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 Neurodegenerative or Movement Disorder diseases; Experience in RMS PMS or MG preferred.
Experience/Professional requirement:
- 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 3 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
- Advanced knowledge of assigned therapeutic area
- demonstrated ability to establish strong scientific partnership with key stakeholders
- Thorough knowledge of GCP clinical trial design and methodology statistical analysis methodology and regulatory/clinical development process
- >1 year of People management experience preferred this may include management in a matrix environment. Global people management experience desirable
- Excellent communication skills written and oral
- Excellent interpersonal skills
- Excellent negotiation and conflict resolution skills
Why Novartis Our purpose is to reimagine medicine to improve and extend peoples 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: receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. 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: Desired
Required Experience:
Director
Employment Type
Full-Time
