The Study Director (SD) will be responsible for the leadership of all aspects of multiple Development Programs in Neurology including the bio-analysis, target finding, drug metabolism, pharmacokinetics, toxicology and clinical pharmacology support in regulatory filings, from the beginning of preclinical development stage through the clinical development. This individual will effectively coordinate and manage team activities tailored to address the specific needs of individual programs, and identify innovative approaches to both increase the speed with which therapies can get the IND approval and enhance the value of programs as assessed by alignment with Target Product Profiles and stakeholders in the ‘Circle of Value’. SD will organize CROs and individual employees in development programs and contribute to

• As an experienced preclinical development professional, take a hands-on role in establishing a detailed preclinical development plan, possibly working with a less experienced preclinical representative in the team.
• Manage department team in performing bio-analysis, target finding, drug metabolism, pharmacokinetics, toxicology and clinical pharmacology work toward supporting drug discovery, preclinical development and clinical development projects.
• Tracking progress against project goals and composing monthly reports for senior management and leadership teams outlining key strategic events for projects. These documents contain program milestones, strategic imperatives, and financial information regarding projects.
• Be the lead preclinical representative at key external business meetings (e.g. with regulatory authorities) and the lead presenter at regulatory Advisory Committee meetings.
• Accurate and effective budget management for Development Programs, addressing issues as they arise.
• Line management and/or mentorship of less experienced development program leaders and/or preclinical research staffs. Developing and maintaining professional liaison with all levels of the organization

• PhD Degree, preferably in Pharmacology, Drug Metabolism, Toxicology or related discipline.
• Knowledge and industry experience in pharmacokinetics, target finding, drug metabolism, bio-analysis, toxicology and clinical pharmacology.
• Experience in neurology field, especially neurodegenerative diseases (including Alzheimer’s disease, Parkinson’s disease, Huntington’s disease or amyotrophic lateral sclerosis, ALS), strongly preferred. Strong publication record on neurodegenerative diseases and experience with external Scientific Advisory Boards preferred.
• Around 10 years of research, preclinical, development and management experience in industry or contract research organization with a minimum of 5 years in project or team management position.
• Strong knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe, experienced in global drug development; Working Knowledge of GLP, GMP.
• Proven skills in building teams, supervising personnel, and completing projects
• Aware of changing trends in pharmaceutical drug development, and experience in applying new approaches
• Troubleshooting and solving problems under very challenging timelines while maintaining standards of quality. Applying strategic and business thinking, while also ensuring operational excellence.
• Requires excellent interpersonal skills including active listening, effective meeting management, negotiation, and optimizing group dynamics. Must be open to the ideas of others and utilize different perspectives to drive towards creative solutions.
• Ability for broad strategic thinking in drug development beyond just their area of technical expertise
• Excellent oral and written communication skills in English and German, Proficient computer skills.