Head – Clinical Development

THE OPPORTUNITY

Amylyx is looking for a Head of Clinical Development to be the lead for early development activities for specific pipeline assets. Reporting to the Global Head of Clinical Development, you will be responsible for medical monitoring for assigned early-stage 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. The successful candidate will interact within a multi-disciplinary, matrix work group including research, ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall clinical development plans. You will be involved in potential translational activities, operationalizing studies, monitoring data in real time to ensure the integrity of the study, proactively identifying issues in the conduct of trials, and in medical review and analysis of data for the purposes of both data cleaning and interpretation for regulatory documents and publications. 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.

THE RESPONSIBILITIES

• Provide medical monitoring to assigned neurology clinical trials
• Provide clinical development leadership for programs that integrate extensive knowledge in clinical science and neurology, and inputs from the global medical community
• Work closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans with a focus on pharmacodynamic endpoints
• Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP)
• Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels
• Develop and maintain relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs)
• Act as the primary Clinical Development interface with internal stakeholders as well as external subject matter experts and alliance partners for the assigned programs
• Contribute to specific Business Development activities and various organizational initiatives in Clinical Development

REQUIRED QUALIFICATIONS

• MD required
• Background in translational science is a plus.
• 2+ years of experience in leading 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.
• Ability to travel internationally and domestically

WORK LOCATION AND CONDITIONS

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.