Head of Medical Safety - Mechelen (BE), Leiden (NL) or Basel (CH)

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.

We are looking for a Head of Medical Safety in Mechelen (Belgium), Leiden (The Netherlands) or Basel (Switzerland).

Scope of the job
The Head of Medical Safety will be the responsible strategic leader for the clinical safety and pharmacovigilance activities of Galapagos. You will serve as a member of the GLPG leadership team and function in a global matrix organization interacting with key stakeholders both internally and externally. This is a highly visible role that will interface across all levels and functional areas and will need to partner closely with the clinical development and commercial teams. The exceptional candidate we seek will have a proactive,innovative approach and a flexible, hands-on nature,who works with a high sense of urgency.

Your role

• You will provide guidance, expertise, and strategic direction on all aspects of clinical safety throughout the life-cycle for multiple products/programs in development.
• Ideally ,your safety experience will be centred on the areas of haematology,oncology and immunology. An understanding on the challenges of cell therapy would also be valuable
• You will build and lead a team of safety physicians to support the ongoing evaluation of safety information during clinical development and to provide state-of-the-art proactive risk management.
• You will lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of medicinal products.
• You will build the post-marketing pharmacovigilance operations for the detection and management of safety signals.
• You will guide the clinical development teams regarding all aspects of clinical safety, including trial design, appropriateness of safety endpoints, analysis and interpretation of safety data.
• You will be the accountable content owner for all safety relevant content or safety relevant documents during clinical development (e.g. DSUR, Development Risk Management Plans, Safety Analysis Plans) and post approval (e.g. PSUR, RMPs, medical expert statements and answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters and company statements.
• You will serve as the safety expert providing strategic input to key stakeholders in relation to product safety, understand the business strategy for the product and be knowledgeable about the (medical) context of the respective product class. Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external bodies.

Who are you?

• You have an MD degree combined with minimum 10 years in pharmacovigilance and/or clinical research/clinical safety experience in the pharmaceutical industry.
• You have strong leadership experience in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management
• You have experience interfacing with regulatory and health agencies on a global basis
• You have strong communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
• You have excellent networking and relationship building skills for successful cooperation with internal and external customers.
• You have expertise in international regulations governing drug safety. Experience in managing compliance or audits. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
• You have excellent people management and decision making skills.
• You have strong influencing skills with the ability to quickly earn credibility across other functional areas.
  

What’s in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

We are Galapagos : together we can make it happen…!