POSITION SUMMARY

The Head, Medical Director, Clinical Development will be the clinical development lead for assigned assets in Neurology primarily in early development. This position will also support the Clinical Development team in activities for planned late stage clinical trials. Reporting to the Head of Global Clinical Development, you are responsible for medical monitoring for assigned clinical trials, the development and implementation of the Clinical Development Plan for the assigned assets, including clinical study design and execution, as well as interpretation of study data. In this role you will interact with multiple functions and management within Amylyx, and with external stakeholders including the global medical expert community, global regulatory authorities, alliance partners and vendors.

RESPONSIBILITIES

• Provides medical monitoring to assigned neurology clinical trials.
• Provides clinical development leadership for programs that integrate extensive knowledge in clinical science and neurology, and inputs from the global medical community.
• Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP).
• Develops Go/No Criteria for early stage programs to enter late stage development.
• Gene therapy and knowledge of neuroscience biomarkers are a plus.
• Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels.
• Develops and maintains relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs).
• Acts as the primary Clinical Development interface with internal stake holders as well as external subject matter experts and alliance partners for the assigned programs.
• Contributes to specific Business Development activities and various organizational initiatives in Clinical Development.

REQUIREMENTS

• MD required; dual MD/PhD combination strongly preferred along with prior clinical or research experience in neuroscience.
• Prior experience as a hands-on medical practitioner, preferably in neurology.
• 8+ years of experience in leading early-stage clinical development programs in the pharmaceutical industry with a proven record of achievements.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment.
• Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment.
• Excellent communication skills (oral and written) and organizational skills.