Director, Clinical Sciences

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remote; USD 214,000 - 241,000; Full time

Job summary

Amylyx Pharmaceuticals, Inc. is seeking a Director of Clinical Sciences to lead scientific support across ongoing and upcoming clinical studies within the Clinical Development team.

The role reports to a Medical Director and collaborates across R&D, program management, clinical operations, biostatistics, and data management. The position requires a Master’s degree with 8+ years in drug development (MD/PhD/ PharmD preferred) and hands-on experience with Phase 1–III trials, GCP/ICH guidelines, and

Qualifications

• Master’s Degree with 8+ years in drug development; advanced degree preferred.
• Knowledge of Phase 1-3 drug development.
• Clinical trial implementation and sponsor/site interactions.
• Experience in endocrine, neurology or rare diseases.
• Familiarity with GCP, ICH, FDA/EMEA guidance and regulations.
• Strong team player with excellent attention to detail and communication.

Responsibilities

• Collaborates with the clinical development team to review, analyze and interpret study results.
• Provides scientific support for Phase I–III trials and helps design upcoming studies.
• Performs monitoring of study data including labs, safety data, and eligibility.
• Authors/reviews CTAs, protocols, CRFs, informed consent, deviations and monitoring plans.
• Contributes to regulatory documents such as CSRs and IND/CTA sections.
• Interacts with external medical advisors, thought leaders, and internal teams to execute the clinical development plan.

Skills

Phase 1-3 drug development

Clinical trial implementation

Sponsor/site interactions

Cross-functional collaboration

Attention to detail and communication

Education

Master’s degree in a relevant scientific or healthcare discipline

Advanced degree preferred (M.D./Ph.D./Pharm.D.)

Job description

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

The 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 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.
• 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, Investor’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.

Requirements

• Master’s Degree in a relevant scientific or healthcare discipline and a minimum of 8 years of relevant drug development experience required. An advanced degree (M.D., Ph.D., or Pharm.D.) is preferred. An equivalent combination of advanced education and relevant industry experience may be considered.
• Knowledge of Phase 1-3 drug development.
• Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
• Prior experience working within endocrine, neurology or rare disease indications.
• 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.

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.
• Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis
• 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.

Compensation

The 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.

$214,000 - $241,000 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn .

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Amylyx Pharmaceuticals’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.