Al Solutions
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Clinical Operations Specialist at AL Solutions
Chloe O'Shea is proud to partner with a global mid-sized biopharmaceutical company at the forefront of innovation in immune-based therapies. We are seeking an experienced Executive Medical Director, Clinical Development to lead strategic clinical initiatives across a dynamic and growing portfolio of autoimmune and rare disease programs. This is a rare opportunity to join a high-impact leadership team driving global clinical development efforts from early- to late-stage, with significant autonomy and visibility in a fast-paced, agile environment. The Role As Executive Medical Director, Clinical Development, you will play a pivotal role in shaping and executing the clinical strategy for one or more key assets across the portfolio. You will provide medical leadership and oversight for global clinical trials across all phases of development, collaborating closely with cross-functional teams and external stakeholders including Key Opinion Leaders, Investigators, Regulatory Authorities, and Patient Advocacy Groups. This role is ideal for a strategic clinical development leader with deep expertise in immunology or rheumatology, proven experience in late-phase trials, and a passion for transforming the lives of patients living with autoimmune diseases. Key Responsibilities Lead the clinical development strategy for multiple global autoimmune programs. Design and author clinical trial protocols, study synopses, and clinical development plans. Oversee medical monitoring and ensure patient safety, data integrity, and GCP compliance. Interpret study data and author clinical study reports (CSRs). Collaborate with biostatistics to define statistical analysis plans and interpret results. Establish strong relationships with global KOLs and investigators to inform trial design and execution. Support regulatory strategy including submissions, responses, and health authority meetings. Contribute to scientific publication and presentation strategy across key conferences and journals. Requirements MD or MD/PhD with 810+ years of clinical development experience, ideally in autoimmune or immunologic disorders. SLE Experience. Significant experience leading late-stage global clinical studies. Deep knowledge of clinical trial design, regulatory expectations, and safety oversight. Demonstrated ability to lead cross-functional teams and work effectively in a matrixed, global environment. Prior experience with China-based or international development programs is highly valued. Strong communication skills and ability to operate with urgency, transparency, and excellence. Comfortable working in a fast-moving, start-up-like culture with evolving processes. Whats in It for You? Leadership visibility and the opportunity to shape global clinical strategy from the ground up. A collaborative, mission-driven environment focused on bringing innovative therapies to patients. Cross-functional engagement with global operations, regulatory, commercial, and scientific stakeholders. Remote flexibility or hybrid work options depending on location. Career advancement opportunities within a growing organization focused on immunology innovation. If youre a senior clinical development leader looking for an opportunity to make a global impact while advancing best-in-class autoimmune therapies, wed love to hear from you. Apply today to be part of a passionate and forward-thinking team transforming the future of immunology care. Seniority level
Seniority level
Executive Employment type
Employment type
Full-time Job function
Job function
Research Industries
Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at AL Solutions by 2x Sign in to set job alerts for Medical Director roles.
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Chloe O'Shea is proud to partner with a global mid-sized biopharmaceutical company at the forefront of innovation in immune-based therapies. We are seeking an experienced Executive Medical Director, Clinical Development to lead strategic clinical initiatives across a dynamic and growing portfolio of autoimmune and rare disease programs. This is a rare opportunity to join a high-impact leadership team driving global clinical development efforts from early- to late-stage, with significant autonomy and visibility in a fast-paced, agile environment. The Role As Executive Medical Director, Clinical Development, you will play a pivotal role in shaping and executing the clinical strategy for one or more key assets across the portfolio. You will provide medical leadership and oversight for global clinical trials across all phases of development, collaborating closely with cross-functional teams and external stakeholders including Key Opinion Leaders, Investigators, Regulatory Authorities, and Patient Advocacy Groups. This role is ideal for a strategic clinical development leader with deep expertise in immunology or rheumatology, proven experience in late-phase trials, and a passion for transforming the lives of patients living with autoimmune diseases. Key Responsibilities Lead the clinical development strategy for multiple global autoimmune programs. Design and author clinical trial protocols, study synopses, and clinical development plans. Oversee medical monitoring and ensure patient safety, data integrity, and GCP compliance. Interpret study data and author clinical study reports (CSRs). Collaborate with biostatistics to define statistical analysis plans and interpret results. Establish strong relationships with global KOLs and investigators to inform trial design and execution. Support regulatory strategy including submissions, responses, and health authority meetings. Contribute to scientific publication and presentation strategy across key conferences and journals. Requirements MD or MD/PhD with 810+ years of clinical development experience, ideally in autoimmune or immunologic disorders. SLE Experience. Significant experience leading late-stage global clinical studies. Deep knowledge of clinical trial design, regulatory expectations, and safety oversight. Demonstrated ability to lead cross-functional teams and work effectively in a matrixed, global environment. Prior experience with China-based or international development programs is highly valued. Strong communication skills and ability to operate with urgency, transparency, and excellence. Comfortable working in a fast-moving, start-up-like culture with evolving processes. Whats in It for You? Leadership visibility and the opportunity to shape global clinical strategy from the ground up. A collaborative, mission-driven environment focused on bringing innovative therapies to patients. Cross-functional engagement with global operations, regulatory, commercial, and scientific stakeholders. Remote flexibility or hybrid work options depending on location. Career advancement opportunities within a growing organization focused on immunology innovation. If youre a senior clinical development leader looking for an opportunity to make a global impact while advancing best-in-class autoimmune therapies, wed love to hear from you. Apply today to be part of a passionate and forward-thinking team transforming the future of immunology care. Seniority level
Seniority level
Executive Employment type
Employment type
Full-time Job function
Job function
Research Industries
Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at AL Solutions by 2x Sign in to set job alerts for Medical Director roles.
Site Director (PACE Center) Great Opportunity Lowell, MA
Medical Operations Manager/ Practice Manager
Regional Medical Director (Remote - Multiple Locations)
Boston, MA $135,000.00-$180,000.00 1 month ago Executive Director Medical Affairs, Operations and Strategic Excellence
Senior Director, Medical Execution - Hypertension
Boston, MA $233,644.00-$350,466.00 16 hours ago Sr. Director Global Quality Assurance (GLP/GCP)
Beverly, MA $78,834.00-$98,543.00 3 weeks ago Medical Director, Spinal Muscular Atrophy - Global Medical Affairs
Cambridge, MA $209,000.00-$288,000.00 1 week ago Chief Medical Officer, Global Oncology Business Unit
Cambridge, MA $336,000.00-$462,000.00 6 days ago Waltham, MA $205,000.00-$260,000.00 4 months ago Head (Executive Director) Rare Disease, US Medical Affairs
Cambridge, MA $296,000.00-$418,000.00 1 month ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr