The Senior Global Clinical Safety Physician Early Development is a key role within Clinical Safety and Pharmacovigilance driving the safety risk management strategy for early development and promoting it across thecompany.
The Senior Global Clinical Safety Physician Early Development is a key role within Clinical Safety and Pharmacovigilance driving the safety risk management strategy for early development and promoting it across the company.
- Integration of all relevant aspects into a cohesive safety strategy for phase I and beyond that includes the pharmacovigilance perspective on life-cycle management
- Scientific guidance to product strategy teams and senior management
Development of expertise for a group of clinical safety physicians to ensure the proper development and implementation of the safety strategy for a medicinal product.
- The company response concerning evolving safety regulations for early development
The early assets are being developed out of CSL sites in Melbourne Australia, where the main presence of him/her is expected.
Main Responsibilities and Accountabilities:
- Be the lead / go to person in GCSP for safety in early development phases both internally by leading a group of clinical safety physicians in and across Therapeutic Area/s (TA) and externally in relevant team and governance meetings. This will include operational- and performance management.
- Guide the clinical development team(s) of the early clinical development projects and liaise closely with the TA heads and teams of Clinical Strategy and Development regarding all aspects of clinical safety and risk management aspects, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data.
- Define the strategy for cooperation with KOLs, Advisory Boards and Drug Safety Monitoring Boards.
- Oversee and be accountable for timely delivery of all safety deliverables for early clinical development projects across TAs towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
- Oversee and guide the active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature at the start, and during early clinical development and all phases of the life-cycle of a defined portfolio of medicinal products
- Actively and cooperatively manage the multiple interfaces eg. with research, toxicology, pharmacology or translational science, global regulatory affairs
- Have the oversight over the early development portfolio, the business context and guide clinical safety physicians accordingly. Act as safety expert providing strategic input to key stake holders in relation to product safety, understand the business strategy for the product and be knowledgeable about the (medical) context of the respective product class
Position Qualifications and Experience Requirements
- Physician (MD or equivalent)
- Minimum 5 years pharmacovigilance and / or clinical research / clinical safety experience in the pharmaceutical environment (industry, CRO) with special focus in early clinical development /Phase 1 studies. Proven capability to translate preclinical data into a risk management strategy for early clinical development.
- Medical practice of at least 2 years, preferred is a specialization in a relevant medical area including medical practice
- Should have leadership experience
- Proven ability to understand and translate preclinical data into safety risk management strategy for conduct of Phase 1 studies-preferably in biologics.
- Understanding of the international regulatory environment governing early clinical development in biologics
- Sound understanding and early clinical research methodology
- Ability to synthesize and analyze safety data from various sources
- Proficiency in problem-solving within a highly complex environment
- Strong communicator with excellent English language skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
- Convincing argumentation and negotiating skills
- Good networking and team skills for successful cooperation with internal and external customers Of advantage:
- Expertise in international regulations governing drug safety
- Knowledge of clinical research methodology, clinical epidemiology/biostatistics pharmacovigilance tools and processes and relevant regulatory framework
- Experience in managing compliance, audits, and inspections