AstraZeneca GmbH
Senior Medical Director, Clinical Development Neurology
AstraZeneca GmbH, Boston, Massachusetts, us, 02298
Overview
This is a neurology medical expert role responsible for the clinical development of neurology assets. The position involves working with cross-functional project teams and typically serving on two or more programs, contributing to strategic disease decisions at the therapeutic area level. It designates medical leadership across drug development stages from IND/CTA through First in Human, Proof of Concept, Phase 2, Phase 3, and regulatory approval. Responsibilities
Serve as subject medical expert and clinical development leader for two or more programs, including preparation and execution of a clinical development strategy and related documents (protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents). Provide clinical development leadership for protocol execution, interact with investigators, contribute to data review and analysis, and prepare final clinical study reports. Provide strategic medical guidance to phase I/II/III development programs and oversee global patient trials with Clinical Operations on assigned programs. Provide medical monitoring for assigned programs and assess safety events in collaboration with Safety teams. Represent the clinical team on cross-functional program teams, contributing medical input to the integrated development plan. Develop medical content for regulatory documents and responses (e.g., pre-IND, IND briefing packages, and common technical documents). Lead identification and external engagement with key opinion leaders for assigned programs (advisory meetings, investigator meetings, patient advocacy organizations). Foster development of Medical Directors and provide scientific input to other R&D, commercial, translational, medicine, and business development functions; lead or oversee clinical activities to support due diligences. Collaborate internally with CDP members to drive program strategy and CDPs; coordinate communications among Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science for study design, execution, and interpretation. Drive awareness of scientific, clinical, competitive, and regulatory developments that could impact the development plan, including attendance at major conferences, competitive intelligence activities, and literature reviews. Work as part of a cross-functional team with biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management colleagues. Qualifications
MD, DO, MBBS (or equivalent) with relevant specialty for the therapeutic area. 7+ years of clinical research experience in neurological diseases with pharmaceutical/CRO industry experience in drug development. Excellent written and oral communication skills. Ability to think strategically and translate strategy into tactical plans to drive outcomes. Adaptable with strong prioritization and time-management skills; willing to take on new responsibilities. Office-based role; must be able to use a computer and engage in communications via phone, video, and electronic messaging; collaborate with others; standard business hours. Willingness to travel to scientific meetings. Preferred
Specialty and/or practice or development experience in Neuromuscular disease (gMG preferred). Rare Disease and/or Cell therapy experience; board certified in Neurology. Peer-reviewed publications and presentations; experience preparing regulatory documents and attending regulatory meetings; multinational trial design experience. History of leading cross-functional teams to define clinical strategy and study design; experience supporting business development activities. Working at Alexion
We’re inspired to think differently, create better outcomes, and deliver innovative medicines and supportive technology with integrity to help people affected by rare diseases. We strive for the highest standards of ethics, diversity, dedication, and medical innovation. This role has an expectation of in-office presence a minimum of 3 days per week, with flexibility for in-person collaboration. AstraZeneca embraces diversity and equality of opportunity and is committed to an inclusive team representing all backgrounds. We comply with applicable laws on non-discrimination and work authorization. Alexion is an Equal Employment Opportunity and Affirmative Action employer and maintains a culture of belonging. Date Posted
22-Sept-2025 Closing Date
12-Oct-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need requiring accommodation, please complete the corresponding section in the application form.
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This is a neurology medical expert role responsible for the clinical development of neurology assets. The position involves working with cross-functional project teams and typically serving on two or more programs, contributing to strategic disease decisions at the therapeutic area level. It designates medical leadership across drug development stages from IND/CTA through First in Human, Proof of Concept, Phase 2, Phase 3, and regulatory approval. Responsibilities
Serve as subject medical expert and clinical development leader for two or more programs, including preparation and execution of a clinical development strategy and related documents (protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents). Provide clinical development leadership for protocol execution, interact with investigators, contribute to data review and analysis, and prepare final clinical study reports. Provide strategic medical guidance to phase I/II/III development programs and oversee global patient trials with Clinical Operations on assigned programs. Provide medical monitoring for assigned programs and assess safety events in collaboration with Safety teams. Represent the clinical team on cross-functional program teams, contributing medical input to the integrated development plan. Develop medical content for regulatory documents and responses (e.g., pre-IND, IND briefing packages, and common technical documents). Lead identification and external engagement with key opinion leaders for assigned programs (advisory meetings, investigator meetings, patient advocacy organizations). Foster development of Medical Directors and provide scientific input to other R&D, commercial, translational, medicine, and business development functions; lead or oversee clinical activities to support due diligences. Collaborate internally with CDP members to drive program strategy and CDPs; coordinate communications among Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology, and Medical Science for study design, execution, and interpretation. Drive awareness of scientific, clinical, competitive, and regulatory developments that could impact the development plan, including attendance at major conferences, competitive intelligence activities, and literature reviews. Work as part of a cross-functional team with biostatistics, data management, clinical pharmacology, commercial, regulatory, and project management colleagues. Qualifications
MD, DO, MBBS (or equivalent) with relevant specialty for the therapeutic area. 7+ years of clinical research experience in neurological diseases with pharmaceutical/CRO industry experience in drug development. Excellent written and oral communication skills. Ability to think strategically and translate strategy into tactical plans to drive outcomes. Adaptable with strong prioritization and time-management skills; willing to take on new responsibilities. Office-based role; must be able to use a computer and engage in communications via phone, video, and electronic messaging; collaborate with others; standard business hours. Willingness to travel to scientific meetings. Preferred
Specialty and/or practice or development experience in Neuromuscular disease (gMG preferred). Rare Disease and/or Cell therapy experience; board certified in Neurology. Peer-reviewed publications and presentations; experience preparing regulatory documents and attending regulatory meetings; multinational trial design experience. History of leading cross-functional teams to define clinical strategy and study design; experience supporting business development activities. Working at Alexion
We’re inspired to think differently, create better outcomes, and deliver innovative medicines and supportive technology with integrity to help people affected by rare diseases. We strive for the highest standards of ethics, diversity, dedication, and medical innovation. This role has an expectation of in-office presence a minimum of 3 days per week, with flexibility for in-person collaboration. AstraZeneca embraces diversity and equality of opportunity and is committed to an inclusive team representing all backgrounds. We comply with applicable laws on non-discrimination and work authorization. Alexion is an Equal Employment Opportunity and Affirmative Action employer and maintains a culture of belonging. Date Posted
22-Sept-2025 Closing Date
12-Oct-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. If you have a disability or special need requiring accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr