Amylyx Pharmaceuticals
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Director, Clinical Sciences
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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 Science 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, 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 (M.D., Ph.D., Pharm.D., Master’s Degree in Science/Medical-related field).
- MD, PhD or PharmD with 3+ years Clinical Research, Pharmaceutical, or CRO experience, OR Master’s degree with 8+ years of relevant experience.
- Knowledge of Phase 1-3 drug development.
- Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
- Prior experience working within neurology or neurodegenerative 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.
- 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.
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
To return to our website please click here.
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.
Ready to apply?
Apply to Amylyx Pharmaceuticals
Senior Medical Director, Clinical Development
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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
Amylyx is seeking a Senior Medical Director, Clinical Development to provide strategic and scientific leadership for one or more late-stage, pivotal programs with the potential to expand into additional indications and/or programs within the same molecule or across the portfolio. This individual will play a critical role in shaping the overall clinical development strategy and may lead multiple programs or key components of a broader development portfolio.
Reporting to the Senior VP of Clinical Development, you will be responsible for leading the design, execution, and interpretation of clinical studies and overseeing the development and implementation of Clinical Development Plans across assigned assets. You will provide strategic input into study design, endpoints, and regulatory strategy, ensuring alignment with the overall program and corporate objectives.
The successful candidate will collaborate with cross-functional teams in a matrix environment, influencing stakeholders across Research, Regulatory Affairs, Clinical Operations, and Commercial to ensure that clinical and scientific considerations are fully integrated into development plans. You will proactively identify and mitigate risks, guide decision-making through data-driven insights, and ensure the highest standards of scientific rigor and data integrity.
In this role, you will also serve as a key external representative, engaging with global medical experts, investigators, regulatory authorities, and alliance partners. You may lead or mentor a team of clinical scientists and physicians and contribute to broader organizational and portfolio-level initiatives.
Responsibilities
- Provides strategic medical leadership and oversight for assigned clinical programs, including late-stage and pivotal trials.
- Leads development and execution of Clinical Development Plans (CDPs), integrating clinical, scientific, regulatory, and commercial considerations.
- Drives study design, protocol development, and interpretation of complex clinical data to inform key program decisions.
- Serves as a core member of cross-functional program teams, influencing strategy and ensuring alignment across disciplines.
- Provides senior-level medical monitoring and guidance, ensuring patient safety, data integrity, and high-quality trial execution.
- Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners.
- Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications.
- Mentors and provides scientific guidance to junior team members, including Medical Directors and Clinical Scientists.
- Identifies and implements process improvements and best practices within Clinical Development.
Required Qualifications
- MD required
- Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry; rare disease experience strongly preferred
- Typically 5+ years of experience leading clinical development programs with demonstrated impact on program strategy and execution
- Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment
- Strong strategic thinking, problem-solving, and decision-making skills
- Proven ability to interpret complex clinical data and translate insights into actionable strategies
- Excellent communication and leadership skills, with experience interacting with senior stakeholders and external experts
- Experience mentoring or leading team members preferred
- Ability to travel internationally and domestically
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.
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.
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
To return to our website please click here.
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.
Ready to apply?
Apply to Amylyx Pharmaceuticals
Vice President, Clinical Pharmacology
Share this job
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 Position
The Vice President of Clinical Pharmacology will provide leadership and support to the clinical pharmacology team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all drugs and drug candidates in development and, as applicable, through commercialization. As the clinical pharmacology expert within the company, you have experience and expertise in matrixed leadership and team management, and will lead, develop, and educate through cross-functional teams. In addition, there will be opportunities to contribute to diligence assessments. Reporting directly to the SVP, Head of Clinical Development, you will have high visibility at leadership levels, including with the Chief Medical Officer. You can efficiently and effectively synthesize internal and external data to produce a clinical pharmacology strategy.
Responsibilities
- Serve as the clinical pharmacologist for the company across all clinical programs, providing strategic and scientific input from preclinical development through Phase 3 trials
- Lead the Clinical Pharmacology team accountability for the clinical pharmacology strategy for Amylyx' development portfolio from pre-IND through and post approval, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions
- Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, toxicology to support and impact development decisions
- Ensure appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program.
- Collaborates with toxicologist and preclinical pharmacology scientists to design, analyze, interpret, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-human studies
- Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
- Serves as the clinical Pharmacology expert across study and program teams
- Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programs
- Contributes to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
- Works closely with research and development teams and provides input into assay development, CRO selection and CRO management. Leads method development, method qualification, method validation activities as SME and sponsor monitor, as assigned.
- Represents nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
- Creates or guides nonclinical and clinical pharmacology summary documents
- Reviews literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology; Authors/ reviews manuscripts for submission to peer-reviewed journals
Required Qualifications
- PhD, PharmD, MD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines
- Minimum 12 years of experience within the pharmaceutical and biotechnology industry with 5+ years' direct experience in Clinical Pharmacology
- Experience in an array of molecules including biologics, small molecules and gene therapy
- Demonstrated experience in writing, presenting, and discussing clinical pharmacology with regulatory authorities as well as other external and internal stakeholders
- Strong analytical skills and ability to interpret complex clinical data sets as well as deep understanding of individual patient data coupled with excellent written and verbal communication skills
- Ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs
- Strong technical proficiency in PK analysis (NCA and PopPK)
- Ability to work with an elevated level of integrity, accuracy, and attention to detail, while executing corporate objectives and goals
- Entrepreneurial, enjoys working in a fast-paced, small-company environment
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.
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.
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
To return to our website please click here.
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.
Ready to apply?
Apply to Amylyx Pharmaceuticals