Medical Director

Purpose of the position

• Coordinate and manage all scientific supporting documentation related to IPSEN products and therapeutic areas where is company involved
• To coordinate in collaboration with Group Medical department the local performance of clinical trials
• Responsibility for regulatory affairs and pharmacovigilance

Main responsibilities and tasks

Clinical trials and development:

• To facilitate and coordinate the participation of Ipsen in clinical trials developed by IPSEN Group
• To ensure Ipsen provides trial feasibility evaluation to global team via dedicated medical advisor.
• To establish, implement, advise and coordinate local clinical study protocols, reports and publications viz. feasibilities.
• Ensure full support for Pharmacovigilance including compliance with Adverse Event reporting and ensure risk management plan implementation
• Ensures providing support and consulting advisory to local group of clinical monitors
• Assist in resolving country specific issues in clinical trial preparation/execution
• To ensure contact with local HCP regarding international as well as local research projects

Business support:

• To manage and mentor medical advisors and MSLs and conduct their performance appraisal for medical affairs and lead medical organization to deliver effective teamwork
• Sets medical affairs strategy for the portfolio in cooperation with other departments and aligns the medical strategy with regional strategies and plans
• To deploy medical affairs team members including MSLs
• Ensures execution of medical affairs activities in the country with highest standards of quality and compliance
• Leads the medical scientific communication, medical education and medical expert/KOL interactions
• Develops and manages long-term relationship with external stakeholders/KOLs
• Whenever requested, provide expert clinical opinion/information to external and internal customers – ensures medical product training for Ipsen sales force staff
• To support Marketing department in the supervise, review, and approval of promotional materials from medical point of view ensuring that all local legal requirements and other applicable (e.g. Ethical codes) as well as those established by the Ipsen Group are met, ensure highest quality of scientific non-promotional materials prepared by medical department as well
• Maintaining a "library" of relevant articles, presentations provided by experts to IPSEN
• To participate at brand teams, work and campaigns preparation
• Participate at preparation of Budget and Strategic plan with focus on medical activities and their budget management

Regulatory and pharmacovigilance:

• To ensure that clinical studies, regulatory requirements and medical pharmacovigilance system is provided in compliance with Ipsen SOPs and national regulations for all actual and future Ipsen products
• To ensure that clinical studies, regulatory requirements and medical pharmacovigilance system is provided in compliance with Ipsen SOPs and national regulations for all actual and future Ipsen products
• In an area of regulatory affairs ensure timely and quality submissions to relevant regulatory authorities
• To ensure the required medical support to pharmacovigilance responsible person in all matters related to this area
• Cooperation on pricing and reimbursement issues
• On time reports spontaneous adverse events and technical complaints for all Ipsen products

Qualification and Experience:

• Education: Medical doctor – University degree in Medicine
• Experience: Minimum 5 years of experience in Medical department of multinational company, experience with a management of clinical trials, regulatory and pharmacovigilance activities
• Fluent English – written and spoken
• General knowledge of local regulatory and pharmacovigilance rules
• Project Management
• Excellent communication and organizational skills