Clinical Scientist, Director; m​/f​/d

Location:

Berlin (Germany) or Madrid (Spain)

Department:
Medical Evidence Science & Operations

We are looking for an experienced Clinical Scientist to provide scientific and operational leadership across observational and epidemiological research programs. In this role, you will lead the execution of multiple epidemiological, non-interventional, pragmatic, and low-interventional studies and research collaborations. You will work across a global matrix and partner closely with Medical Evidence Development, Medical Affairs, Statistics, Clinical Data Sciences, Statistical Data Sciences & Analytics, and external study partners.

Key responsibilities Lead the end-to-end execution of multiple studies across applicable standard operating procedures. Co‑lead study core teams and provide direction through a matrix organization. Oversee protocols, study training, operational planning, vendor delivery, data review, regulatory documentation, study reports, and publications. Maintain a consistent focus on study quality, data integrity, safety, and alignment with company processes. Represent the function in program-level discussions and governance forums.

Provide matrix oversight for other Clinical Scientists where required, including work review, development support, and ongoing feedback. Serve as a subject‑matter expert for Clinical Scientist decisions affecting studies or programs. Lead or support preparation for regulatory submissions, regulatory questions, inspections, and audits. Present and discuss data with internal teams, governance bodies, external consultants, key opinion leaders, and potentially regulatory stakeholders.

Champion research and development initiatives and process improvements.

• Lead the end-to-end execution of multiple studies across applicable standard operating procedures.
• Co‑lead study core teams and provide direction through a matrix organization.
• Oversee protocols, study training, operational planning, vendor delivery, data review, regulatory documentation, study reports, and publications.
• Maintain a consistent focus on study quality, data integrity, safety, and alignment with company processes.
• Represent the function in program-level discussions and governance forums.
• Provide matrix oversight for other Clinical Scientists where required, including work review, development support, and ongoing feedback.
• Serve as a subject‑matter expert for Clinical Scientist decisions affecting studies or programs.
• Lead or support preparation for regulatory submissions, regulatory questions, inspections, and audits.
• Present and discuss data with internal teams, governance bodies, external consultants, key opinion leaders, and potentially regulatory stakeholders.
• Champion research and development initiatives and process improvements.

• Bachelor’s degree in life sciences or a health‑related field plus at least 10 years of relevant experience; or Master’s degree/MBA plus at least 8 years; or PharmD/PhD plus at least 6 years; or MD/DO plus at least 3 years of relevant experience.
• Hands‑on experience in study design, conduct, and analysis.
• Experience leading global, operational, or strategic study teams.
• Extensive knowledge of clinical research, Good Clinical Practice, monitoring, and regulatory operations.
• Independent authorship of study protocols and related study documents.
• Working knowledge of statistics, data analysis, and interpretation.
  
  Experience managing external vendors or research partners.
• Strong communication, collaboration, influencing, negotiation, and problem‑solving skills.

• Global study and program scope.
• Approximate travel requirement: 10% domestic and international.
• Occasional evening and weekend…