Clinical Development Medical Director - Dermatology Job ID REQ-10038916
Feb 13, 2025
Ireland
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.
About the Role The Clinical Development Medical Director (CDMD) for Dermatology 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.
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 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 and internal partners.
Work with NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences to drive transition of pre-PoC projects to DDP.
Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes.
Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule.
May serve on or lead global 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 is required.
5+ years' experience in clinical research or drug development from the pharma/biotech industry.
3+ years of contribution to and accomplishment in all aspects of conducting clinical trials.
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.
Exhibit excellent business communication and presentation skills.
Possess strong interpersonal skills.
Adept with excellent negotiation and conflict resolution skills.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's 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!
#J-18808-Ljbffr