Clinical Development Medical Director Ophthalmology
Vor 3 Tagen
12,000 This is the number of global drug development associates Novartis has worldwide. We are courageous in developing transformational medicines to address the unmet needs of patients. As an Associate/Clinical Development Medical Director (a/CDMD or CDMD**), you will join the ophthalmology team, who are committed to helping patients.
You will be responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data and clinical development programs, depending on the size and complexity.
Your responsibilities will include:
- Clinical leadership, medical and scientific input, and contribution to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) consistent with Integrated Development Plan (IDP). Developing materials for advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis medical organizations
- Contribution 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 members, ensure direct medical support of trials as needed and may act as medical monitor. Conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s), lead patient safety and report on trial data to safety boards (e.g., Safety Management Team, GCT, GPT) and provide input into analyses and interpretation including the development of the Clinical Study Report(s), publications and presentations
- Under the direction of the (Sr.) GPCH or (Sr.) CDMD contribute to ensuring overall safety of the compound for assigned trial(s) with Patient Safety
Participate in developing talent and careers of Clinical Development associates through on-boarding, coaching, and/or mentoring support; develop and champion Clinical Development culture; and may contribute to the performance evaluation Team members
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
What you’ll bring to the role:
- MD or equivalent medical degree required. Sophisticated knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) preferred
- Solid understanding of the disease area (Ophthalmology) with validated ability to interpret, discuss and present efficacy and safety data relating to trial(s) at program level
- Previous experience of clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. (Associate CDMD 3 years, CDMD >7 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
- Proven ability to establish effective working relationship with partners
- Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Proficient oral and written English skills
**Division**
Global Drug Development
**Business Unit**
CD&A GDD
**Country**
Switzerland
**Work Location**
Basel
**Company/Legal Entity**
Novartis Pharma AG
**Alternative Country 1**
USA
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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