Senior Medical Director, Nephrology

Apellis Pharmaceuticals; Waltham (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

An established industry player is seeking a Senior Medical Director of Nephrology to lead clinical studies and regulatory interactions. This pivotal role requires extensive experience in clinical research, particularly within nephrology, and the ability to provide medical oversight for critical studies. The ideal candidate will possess strong analytical skills, a collaborative work style, and a proactive approach to process improvements. Join a dynamic team focused on advancing innovative therapies in a fast-paced environment, where your expertise will significantly impact patient outcomes and clinical advancements.

Benefits

401(k)

Flexible Time Off

Paid Family Leave

Comprehensive Insurance

Family Building Benefits

Qualifications

• 8+ years of experience in clinical research, particularly in nephrology.
• Experience with regulatory agencies and clinical trial management.

Responsibilities

• Lead clinical interactions with regulatory agencies and oversee studies.
• Draft clinical study reports and author regulatory documents.
• Provide medical oversight for nephrology clinical studies.

Skills

Clinical Research

Nephrology Expertise

Regulatory Interaction

Analytical Skills

Problem-Solving

Critical Thinking

Multitasking

Education

MD or DO degree

Job description

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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

1. Serve as the clinical lead in interactions with regulatory agencies.
2. Lead development of clinical study protocols.
3. Provide sponsor medical oversight for nephrology clinical studies.
4. Medical monitoring, coding, and data cleaning in collaboration with clinical operations and data management.
5. Serve as the primary contact for clinical trial staff at study sites for clinical issues, regulatory, safety, and other functions.
6. Lead the draft of clinical study reports.
7. Author clinical sections of regulatory documents including study protocols, investigator brochures, briefing documents, annual updates, and patient informed consent documents.
8. Support or prepare data interpretation and clinical trial reports.
9. Act as an internal resource for functions requiring clinical input and nephrology expertise.
10. Write manuscripts, publications, or other documents for external audiences.
11. 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.