The OpportunityThe Senior Director, Clinical Sciences will be a key member of the Clinical Development team with responsibilities to provide scientific support for ongoing activities. This role will report to a Senior Medical Director and will collaborate cross functionally with R&D, program management, clinical operations, biostatistics, and data management. The selected candidate will support and drive key development activities for clinical studies and overall execution of program Clinical Development Plans (CDP).
Responsibilities- Collaborates with the clinical development team in review, analysis, and interpretation of study results.
- Provides scientific support on ongoing Phase I to III clinical trials and contributes to the planning and design of upcoming clinical studies.
- Performs monitoring and review of study data including labs, safety data, and patient eligibility and consults with the program physician as needed.
- Authors and/or reviews clinical trial-related documents including protocols, CRF, informed consent, protocol deviations, monitoring plans and regulatory documents, etc.
- Contributes to regulatory documents including CSRs, Investigator's Brochures, and Clinical sections of INDs, CTAs.
- Interacts with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the clinical development plan.
Required Qualifications- Advanced degree (., Ph.D., Pharm.D., Master's Degree in Science/Medical-related field). PhD or PharmD with 5+ years Clinical Research, Pharmaceutical, or CRO experience, OR Master's degree with 10+ years of relevant experience.
- Knowledge of Phase 1-3 drug development.
- Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
- Well-versed in relevant applications of GCP (Good Clinical Practice), ICH, FDA, EMEA and other relevant guidelines and regulations.
- Strong, collaborative team-player.
- Excellent attention to detail and communication skills.
Preferred Requirements- Prior experience working in rare disease within neurology or endocrinology
Work Location and Conditions- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
- You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
CompensationThe pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.
Estimated Pay Range
$257,000-$289,000 USD
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