Amylyx Pharmaceuticals
Senior Medical Director, Clinical Development
Amylyx Pharmaceuticals, Cambridge, Massachusetts, us, 02140
Senior Medical Director, Clinical Development
Cambridge, MA - Remote Amylyx is a clinical-stage pharmaceutical company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people and core values: be audacious, be curious, be authentic, be engaged, and be accountable. We are seeking a Senior Medical Director, Clinical Development to lead a late-stage, pivotal program and potentially additional programs with the same molecule. The role may involve leading additional development programs with other assets and leading a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, responsibilities include medical monitoring for assigned trials, developing and implementing the Clinical Development Plan (CDP), clinical study design and execution, and interpretation of study data. You will collaborate within a multi-disciplinary, matrix team to ensure clinical and scientific issues are appropriately considered in individual studies and overall development plans. The role may involve translational activities, operationalizing studies, real-time data monitoring, identifying trial conduct issues, and medical review/analysis for regulatory documents and publications. You will interact with internal teams and external stakeholders including global medical experts, regulatory authorities, alliance partners and vendors. Responsibilities
Provides medical monitoring to assigned clinical trials in serious endocrine conditions, neurodegenerative and/or rare diseases. Provides clinical development leadership for programs integrating clinical science with inputs from global medical and patient communities. Works with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to gather scientific and medical knowledge to support CDPs. Develops and maintains a solid Clinical Development Plan (CDP) by integrating scientific rationale, regulatory requirements, product development plan, and value to patients. Produces high-quality program-related documents (protocols, informed consent, clinical study reports, briefing documents, drug labels). Develops and maintains relationships with counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and CROs. Acts as the primary Clinical Development interface with internal stakeholders and external subject matter experts and alliance 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/pharmaceutical industry with a proven track record Critical thinking, troubleshooting and problem-solving skills Demonstrated leadership and ability to work in a multi-disciplinary environment Ability to lead directly and by influence; strong interpersonal, analytical and conflict-resolution skills in a matrix environment Excellent written and oral 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 coverage and state tax regulations. Currently not considering applicants from Alaska, Arizona, Delaware, Hawaii and Kansas. Travel to the Cambridge, MA corporate location several times a year and to 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. Equal Employment Opportunity Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of protected characteristics. Accommodations are available for candidates in our selection process. If you need an accommodation, please contact your Amylyx Talent Acquisition representative. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. This policy is described by state law and related penalties are in place. To stay connected with Amylyx Pharmaceuticals, follow us on LinkedIn.
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Cambridge, MA - Remote Amylyx is a clinical-stage pharmaceutical company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people and core values: be audacious, be curious, be authentic, be engaged, and be accountable. We are seeking a Senior Medical Director, Clinical Development to lead a late-stage, pivotal program and potentially additional programs with the same molecule. The role may involve leading additional development programs with other assets and leading a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, responsibilities include medical monitoring for assigned trials, developing and implementing the Clinical Development Plan (CDP), clinical study design and execution, and interpretation of study data. You will collaborate within a multi-disciplinary, matrix team to ensure clinical and scientific issues are appropriately considered in individual studies and overall development plans. The role may involve translational activities, operationalizing studies, real-time data monitoring, identifying trial conduct issues, and medical review/analysis for regulatory documents and publications. You will interact with internal teams and external stakeholders including global medical experts, regulatory authorities, alliance partners and vendors. Responsibilities
Provides medical monitoring to assigned clinical trials in serious endocrine conditions, neurodegenerative and/or rare diseases. Provides clinical development leadership for programs integrating clinical science with inputs from global medical and patient communities. Works with Medical Directors, Pharmacology, Drug Discovery, external experts, and investigators to gather scientific and medical knowledge to support CDPs. Develops and maintains a solid Clinical Development Plan (CDP) by integrating scientific rationale, regulatory requirements, product development plan, and value to patients. Produces high-quality program-related documents (protocols, informed consent, clinical study reports, briefing documents, drug labels). Develops and maintains relationships with counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and CROs. Acts as the primary Clinical Development interface with internal stakeholders and external subject matter experts and alliance 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/pharmaceutical industry with a proven track record Critical thinking, troubleshooting and problem-solving skills Demonstrated leadership and ability to work in a multi-disciplinary environment Ability to lead directly and by influence; strong interpersonal, analytical and conflict-resolution skills in a matrix environment Excellent written and oral 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 coverage and state tax regulations. Currently not considering applicants from Alaska, Arizona, Delaware, Hawaii and Kansas. Travel to the Cambridge, MA corporate location several times a year and to 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. Equal Employment Opportunity Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of protected characteristics. Accommodations are available for candidates in our selection process. If you need an accommodation, please contact your Amylyx Talent Acquisition representative. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. This policy is described by state law and related penalties are in place. To stay connected with Amylyx Pharmaceuticals, follow us on LinkedIn.
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