Apellis Pharmaceuticals
Senior Medical Director, Nephrology
Apellis Pharmaceuticals - Watertown, Massachusetts, us, 02472
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Senior Medical Director, Nephrology
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Senior Medical Director, Nephrology
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Apellis Pharmaceuticals Position Summary The Senior Medical Director of Nephrology will be a key contributor to the Nephrology Program at Apellis. This position will oversee clinical studies in C3G and IC-MPGN and participate in clinical development activities for potential future indications. Responsibilities include leading interactions with regulatory agencies, monitoring clinical studies, reviewing and interpreting clinical trial data, and authoring clinical study and regulatory communications. Key Responsibilities Include Serve as the clinical lead in interactions with regulatory agencies. Lead development of clinical study protocols. Provide sponsor medical oversight for nephrology clinical studies. Medical monitoring, coding, and data cleaning in collaboration with clinical operations and data management. Serve as the primary contact for clinical trial staff at study sites for clinical issues, regulatory, safety, and other functions. Lead the draft of clinical study reports. Author clinical sections of regulatory documents including study protocols, investigator brochures, briefing documents, annual updates, and patient informed consent documents. Support or prepare data interpretation and clinical trial reports. Act as an internal resource for functions requiring clinical input and nephrology expertise. Write manuscripts, publications, or other documents for external audiences. Lead clinical advisory boards and support Medical Affairs as needed.
Education, Registration & Certification Must have an MD or DO degree (or international equivalent).
Experience 8+ years of experience in clinical research; phase III clinical trial experience is a plus. Prior experience in nephrology is required. Experience in interaction with regulatory agencies and payers. Experience managing CROs. Experience initiating and managing or participating in industry clinical trials. Experience presenting medical data to diverse audiences. Strong analytical skills and problem-solving ability. Self-motivated, assertive, and confident with a sense of urgency and passion. High integrity, accuracy, and attention to detail. Ability to make thoughtful, timely decisions. Collaborative work style with diverse perspectives management. Proactive in process improvements. Entrepreneurial mindset, comfortable in a fast-paced environment. Critical thinking skills. Proven multitasking, prioritization, and execution skills. Ability to operate independently in a startup-like setting.
Physical Demands And Work Environment This is primarily sedentary; some filing, lifting, and bending may be required. The environment is a professional office setting using standard office equipment. Travel Requirements Up to 20% travel expected.
Benefits And Perks Comprehensive benefits including 401(k), family building benefits, flexible time off, paid family leave, insurance, and more. Visit https://apellis.com/careers/ for details. Company Background Apellis is a biopharmaceutical company focused on complement medicine, with approved therapies for geographic atrophy and ongoing clinical programs. More at http://apellis.com and social media channels. EEO Statement Equal opportunity employer; prohibits discrimination based on protected characteristics. Specific considerations for San Francisco applicants are included. Other Duties This job description is not exhaustive; duties may change at any time. #J-18808-Ljbffr
Senior Medical Director, Nephrology
role at
Apellis Pharmaceuticals 6 days ago Be among the first 25 applicants Join to apply for the
Senior Medical Director, Nephrology
role at
Apellis Pharmaceuticals Position Summary The Senior Medical Director of Nephrology will be a key contributor to the Nephrology Program at Apellis. This position will oversee clinical studies in C3G and IC-MPGN and participate in clinical development activities for potential future indications. Responsibilities include leading interactions with regulatory agencies, monitoring clinical studies, reviewing and interpreting clinical trial data, and authoring clinical study and regulatory communications. Key Responsibilities Include Serve as the clinical lead in interactions with regulatory agencies. Lead development of clinical study protocols. Provide sponsor medical oversight for nephrology clinical studies. Medical monitoring, coding, and data cleaning in collaboration with clinical operations and data management. Serve as the primary contact for clinical trial staff at study sites for clinical issues, regulatory, safety, and other functions. Lead the draft of clinical study reports. Author clinical sections of regulatory documents including study protocols, investigator brochures, briefing documents, annual updates, and patient informed consent documents. Support or prepare data interpretation and clinical trial reports. Act as an internal resource for functions requiring clinical input and nephrology expertise. Write manuscripts, publications, or other documents for external audiences. Lead clinical advisory boards and support Medical Affairs as needed.
Education, Registration & Certification Must have an MD or DO degree (or international equivalent).
Experience 8+ years of experience in clinical research; phase III clinical trial experience is a plus. Prior experience in nephrology is required. Experience in interaction with regulatory agencies and payers. Experience managing CROs. Experience initiating and managing or participating in industry clinical trials. Experience presenting medical data to diverse audiences. Strong analytical skills and problem-solving ability. Self-motivated, assertive, and confident with a sense of urgency and passion. High integrity, accuracy, and attention to detail. Ability to make thoughtful, timely decisions. Collaborative work style with diverse perspectives management. Proactive in process improvements. Entrepreneurial mindset, comfortable in a fast-paced environment. Critical thinking skills. Proven multitasking, prioritization, and execution skills. Ability to operate independently in a startup-like setting.
Physical Demands And Work Environment This is primarily sedentary; some filing, lifting, and bending may be required. The environment is a professional office setting using standard office equipment. Travel Requirements Up to 20% travel expected.
Benefits And Perks Comprehensive benefits including 401(k), family building benefits, flexible time off, paid family leave, insurance, and more. Visit https://apellis.com/careers/ for details. Company Background Apellis is a biopharmaceutical company focused on complement medicine, with approved therapies for geographic atrophy and ongoing clinical programs. More at http://apellis.com and social media channels. EEO Statement Equal opportunity employer; prohibits discrimination based on protected characteristics. Specific considerations for San Francisco applicants are included. Other Duties This job description is not exhaustive; duties may change at any time. #J-18808-Ljbffr