Job Purpose
The Senior Medical Director will report directly to the Chief Medical Officer. The Senior Medical Director has the responsibility for driving the medical content of the development plan.
The Senior Medical Director provides medical oversight across the sonelokimab clinical development plan. The Senior Medical Director is a medical advisor to all internal functions regarding clinical development related matters and may deputise for the Chief Medical Officer when asked.
Major Accountabilities:
The Senior Medical Director provides medical oversight across the sonelokimab clinical development plan. The Senior Medical Director is a medical advisor to all internal functions regarding clinical development related matters and may deputise for the Chief Medical Officer when asked.
Major Accountabilities:
- Become a content expert for the molecule and disease area with the organisation and externally.
- Provide clinical, medical and scientific leadership within the medical and broader multifunctional clinical development group.
- Assures GCP, Clinical Operating Guidelines and Standard Operating Procedures are carefully followed.
- Is a core member of the Drug Safety Committee and Clinical Development cross functional leadership teams.
- Deputises on behalf of the Chief Medical Officer when required.
- Represents the main interface between the Medical function with Clinical Operations/Development for project related activities in delivering the overall plan.
- Works with the study Medical Directors and PV Director in ensuring Medical related study responsibilities are met.
- Provides support/guidance to the study Medical team and PV Director as required.
- Inputs into the design and development of protocols.
- Directly contribute to regulatory documentation and attend meetings with the various HA as appropriate.
- Provides clinical oversight across all relevant studies and programs working closely with the appointed CRO.
- Works with the CRO appointed medial monitors to ensure that agreed plans, processes and reporting are achieved and escalates in line with the agreed process in the event issues arise.
- Selects suitable clinical consultants and experts in conjunction with Medical Affairs.
- Plans, schedules and performs, on an ongoing basis, an evaluation of project related clinical data and sets up and reviews with the team the safety data to detect safety signals.
- Ensures correct data interpretation and reporting, including interim analysis and Clinical Study Reports (CSR).
- Has overall accountability for the Benefit: Risk ratio of the program [co-responsibility with PV Director and Regulatory]. Makes recommendations to the Drug Safety Committee.
- Supports the Safety/ Pharmacovigilance group in developing the risk management plan.
- Provides expert input to the medical affairs and commercial team as needed.
- Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
- Where applicable accountable for performance management and the career development plans of his/her reports and actively ensures that they receive appropriate management and technical support and training, including required training in SOPs.
- Selects, interviews and makes hiring recommendations to the Chief Medical Officer in the reporting area.