Amylyx Pharmaceutical Corp.
Senior Medical Director, Clinical Development Cambridge, MA - Remote
Amylyx Pharmaceutical Corp., Oklahoma City, Oklahoma, United States
Senior Medical Director, Clinical Development
Cambridge, MA - Remote Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, focused on PBH, Wolfram syndrome, PSP, and ALS. We pursue opportunities with urgency, rigorous science, and commitment to communities we serve. Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create a culture of caring. If you share our passion and determination, apply. THE OPPORTUNITY
Amylyx is seeking a Senior Medical Director, Clinical Development to lead a late-stage, pivotal program with potential to expand to additional programs with the same molecule. Opportunities to lead additional development programs with other assets may arise, along with leading a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, you will be responsible for medical monitoring for assigned trials, development and execution of the Clinical Development Plan, including study design, execution, and data interpretation. You will work in a multi-disciplinary, matrix environment with research to ensure issues are considered in development of studies and plans. You will be involved in translational activities, operationalizing studies, real-time data monitoring, identifying issues, and medical review/analysis for regulatory documents and publications. You will interact with internal and external stakeholders including global medical experts, regulatory authorities, alliance partners, and vendors. THE RESPONSIBILITIES
Provides medical monitoring to assigned clinical trials in endocrine, neurodegenerative, and/or rare diseases. Leads clinical development programs integrating clinical science with inputs from global medical and patient communities. Works closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate knowledge for development plans. Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build CDP. Produces high-quality program documents: protocols, IBs, clinical study reports, briefing documents, and drug labels. Develops and maintains relationships with counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics, and CROs. Acts as primary Clinical Development interface with internal and external experts and partners for assigned programs. Contributes to Business Development activities and organizational initiatives in Clinical Development. REQUIRED QUALIFICATIONS
MD required Experience with late-stage clinical development and rare diseases strongly preferred 4+ years leading clinical development programs in biotech/pharma with a proven record Critical thinking, troubleshooting, and problem-solving skills Demonstrated leadership and ability to work in a multi-disciplinary environment Leadership by direct and influence, with strong interpersonal and analytical skills in a matrix environment Excellent communication and organizational skills Ability to travel internationally and domestically WORK LOCATION AND CONDITIONS
Remote work opportunities within the United States. Some states are excluded due to health insurance and tax regulations: Alaska, Arizona, Delaware, Hawaii, and Kansas. Travel to Cambridge, MA several times a year and attend other company-related events as necessary. Must have access to a work setting that enables privacy, reliable internet, phone, and video conferencing from a remote location. To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. Amylyx Pharmaceuticals is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex, gender, sexual orientation, marital status, military service, disability, or any other protected characteristic. Accommodations are available in our selection process. If you need an accommodation, contact the Amylyx Talent Acquisition team.
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Cambridge, MA - Remote Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, focused on PBH, Wolfram syndrome, PSP, and ALS. We pursue opportunities with urgency, rigorous science, and commitment to communities we serve. Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create a culture of caring. If you share our passion and determination, apply. THE OPPORTUNITY
Amylyx is seeking a Senior Medical Director, Clinical Development to lead a late-stage, pivotal program with potential to expand to additional programs with the same molecule. Opportunities to lead additional development programs with other assets may arise, along with leading a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, you will be responsible for medical monitoring for assigned trials, development and execution of the Clinical Development Plan, including study design, execution, and data interpretation. You will work in a multi-disciplinary, matrix environment with research to ensure issues are considered in development of studies and plans. You will be involved in translational activities, operationalizing studies, real-time data monitoring, identifying issues, and medical review/analysis for regulatory documents and publications. You will interact with internal and external stakeholders including global medical experts, regulatory authorities, alliance partners, and vendors. THE RESPONSIBILITIES
Provides medical monitoring to assigned clinical trials in endocrine, neurodegenerative, and/or rare diseases. Leads clinical development programs integrating clinical science with inputs from global medical and patient communities. Works closely with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to accumulate knowledge for development plans. Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build CDP. Produces high-quality program documents: protocols, IBs, clinical study reports, briefing documents, and drug labels. Develops and maintains relationships with counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics, and CROs. Acts as primary Clinical Development interface with internal and external experts and partners for assigned programs. Contributes to Business Development activities and organizational initiatives in Clinical Development. REQUIRED QUALIFICATIONS
MD required Experience with late-stage clinical development and rare diseases strongly preferred 4+ years leading clinical development programs in biotech/pharma with a proven record Critical thinking, troubleshooting, and problem-solving skills Demonstrated leadership and ability to work in a multi-disciplinary environment Leadership by direct and influence, with strong interpersonal and analytical skills in a matrix environment Excellent communication and organizational skills Ability to travel internationally and domestically WORK LOCATION AND CONDITIONS
Remote work opportunities within the United States. Some states are excluded due to health insurance and tax regulations: Alaska, Arizona, Delaware, Hawaii, and Kansas. Travel to Cambridge, MA several times a year and attend other company-related events as necessary. Must have access to a work setting that enables privacy, reliable internet, phone, and video conferencing from a remote location. To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn. Amylyx Pharmaceuticals is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex, gender, sexual orientation, marital status, military service, disability, or any other protected characteristic. Accommodations are available in our selection process. If you need an accommodation, contact the Amylyx Talent Acquisition team.
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