Clinical Development Medical Director - Rheumatology
Clinical Development Medical Director - Rheumatology
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Job Description
Job Description Summary
As our Clinical Development Medical Director in our Immunology Development Unit you will be responsible for the scientific and clinical strategy of assigned clinical trials scientific monitoring and reporting of quality data.Job Description
The Clinical Development Medical Director (CDMD) for Rheumatology is the clinical leader of defined program level activities (e.g. submission activities briefing books etc.) or a large complex trial under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g. an indication a new formulation or a specific development phase)
Your responsibilities include but are not limited to:
Provide clinical leadership and medical strategic input for deliverables in the assigned project/program. Deliverables may include sections of individual protocols consistent with the IDP data review program specific standards clinical components of regulatory documents/registration dossiers and publications (e.g. IBs Brochures briefing books safety updates submission dossiers and responses to Health Authorities)
Drive execution of the section of the program in partnership with global line functions assigned Global Trial Directors (GTDs) and regional/country medical associates
Oversee/conduct medical and scientific review of trial data with Clinical Scientific Expert(s). May be the Program Manager of other associates (e.g.. CSE). May function as study medical monitor
Support SR/GPCH in ensuring overall safety of the molecule. May be a core member of the Safety Management Team (SMT) and supports program safety reporting (e.g. PSURs DSURs and safety related documents) in collaboration with Patient Safety
Support the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for disease areas.
Provide support to the (Sr.) GPCH or TAH in interactions with external partners (e.g. regulatory authorities KOLs data monitoring boards AD Boards patient advocacy groups) internal partners (e.g. CTT Research Translational Medicine GMA Marketing HE&OR) and decision boards)
Work with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with additional matters
Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding training & mentoring support
Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise.
May serve on or lead global initiatives (e.g. process improvement training SOP development other Clinical Development line function initiatives)
Minimal Requirements:
MD (or equivalent medical degree) is required.
Medical Board certification preferred. 4 years Clinical practice experience (including residency) is preferred
Possess advanced knowledge and clinical training in a medical/scientific area (e.g. internal medicine or sub-specialty) is required.
5 years experience in clinical research or drug development from the pharma/biotech industry 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
Showcase advanced knowledge of assigned therapeutic area
Demonstrate ability to establish strong scientific partnership with key partners
Need thorough knowledge of GCP trial design statistical analysis methodology and regulatory/ clinical development process
Have people management experience preferred this may include management in a matrix environment. Global people management is preferred.
Exhibit excellent business communication and presentation skills
Possess strong interpersonal skills
Adept with excellent negotiation and conflict resolution skills
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
This hybrid role can be based in Basel London Barcelona Madrid or Dublin.
Read our handbook to learn about all the ways well help you thrive personally and professionally:Novartis Life Handbook
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process or in order to receive more detailed information about the essential functions of a position please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Skills Desired
Clinical Trials Cross-Functional Teams Data Analysis Data Monitoring Drug Development Drug Discovery Medical Research Medical Strategy People ManagementRequired Experience:
Director
Employment Type
Full-Time
