Global Director Clinical Strategy
About the Company:
This medium sized pharmaceutical company already has three commercialised products, with more coming in the pipeline.
The company has focused their efforts on providing products first-of-its-kind products to address previously unmet medical needs. Every member of the team is driven by the knowledge their efforts are providing highly needed solutions for the patients. As an organisation they value internal collaboration and enabling their employees to have an impact on the company.
Candidate can be based anywhere in Europe
Understanding that life and work needs to be balanced, this roles offers hybrid working options that can be tailored to suit the needs of their employees.
The average is 5 days a month fin the office for those in live in the same country as the offices, less for those European citizen outside of target countries.
As Global Director Clinical Strategy your input will be invaluable for the continued development of key pipeline assets to provide vital solutions to the patient population. You’ll be a leader in this organisation, helping to shape the role of yourself and the role of your direct reports.
- Implement strategic goals and objectives, leading clinical development projects of strategic importance.
- Create and lead clinical development strategies, ensuring compliance with regulations (ICH-GCP, FDA/EMA).
- Supervise study protocol generation, data analysis, and safety aspects for development programs.
- Interact with regulatory agencies and key opinion leaders in the therapeutic area of expertise.
- Contribute to scenario planning, support regulatory time-lines, and assist in budget development.
- Provide leadership to cross-functional development project teams, mentoring and training direct reports.
- Drive creation of clinical development plans, ensuring goal attainment and compliance with objectives.
- Oversee clinical strategy deliverables, escalate deviations, and provide regular reviews and reports.
- Contribute to risk management, ensuring adequate team resources and addressing performance issues.
- Accountable for key study documents, safety oversight, and delivery of clinical trial results.
- Maintain up-to-date knowledge of medical and competitive landscapes, escalating competitive intelligence.
- Lead clinical discussions with regulatory authorities, build connections with key opinion leaders.
- Provide clinical expertise for corporate functions, publish relevant clinical data, and contribute to quality assurance activities.
We are looking for:
- MD Educated, or a high level degree within Pharmacy/Life Sciences
- Significant experience within Drug Development across multiple phases – ideally around 10 years
- Strong knowledge on ICH-GCP and regulatory guidelines
- If you have experience in vaccines, this is a significant bonus
- Fluent English
- A strong communicator with leadership qualities
I look forward to receiving your application.