Medical Director / Senior Medical Director - Clinical Development-Rheumatology

Position Summary:

The Medical Director will provide medical support and input to Avalo’s clinical development programs from early-stage trials through to regulatory approval, ensuring alignment with the company’s strategic objectives. The Medical Director will be responsible for collaborating with clinical operations, regulatory, translational medicine/biomarkers, clinical pharmacology, CMC, and quality assurance functions; liaising with clinical investigators and site personnel; and establishing and building relationships with key external experts. The position requires a leader with experience working with CROs and vendors and interfacing with investigator sites to ensure operational efficiency and effective execution of trials within a complex, fast-paced environment.

Essential Duties and Responsibilities:

• Provide medical leadership and oversight for assigned clinical program(s).
• Contribute to early clinical development strategy, including dose selection and clinical trial design, safety monitoring, biomarker strategy, and proof-of-mechanism approaches.
• Support the design, review, and execution of clinical protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory documents in compliance with clinical development plans, GCP, and good medical practice.
• Serve as Medical Monitor for ongoing clinical studies, including review of eligibility criteria, safety data, adverse events, protocol deviations, and dose escalation decisions.
• Collaborate closely with Clinical Operations, Translational Medicine, Biometrics, Regulatory Affairs, Pharmacovigilance, CROs, and external vendors to support high-quality study execution.
• Provide medical writing support in preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling.
• Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials, and develop and implement risk management strategies.
• Participate in Safety Review Committees, data review discussions, and cross-functional development activities.
• Analyze, interpret and communicate emerging clinical, PK/PD, biomarker, and safety data to internal and external stakeholders.
• Support regulatory interactions, including IND submissions, briefing documents, and responses to health authority inquiries.
• Develop and maintain relationships with investigators, key opinion leaders (KOLs), advisory boards, and scientific experts.
• Present clinical and scientific findings internally and externally, including investigator meetings and scientific conferences.
• Maintain awareness of scientific advancements, emerging therapies, and competitive developments within rheumatology, immunology, and inflammatory diseases.
• Ensure studies are conducted in compliance with ICH-GCP guidelines, company SOPs, and applicable regulatory requirements.

Required Education and Experience:

• MD or equivalent medical degree required.
• Background or therapeutic experience in Rheumatology, Immunology, Autoimmune Disease, or related inflammatory conditions.
• Minimum of 5+ years of biotechnology, pharmaceutical, academic medicine, clinical research, or related clinical development experience.
• Direct clinical experience supporting or leading late-stage (phase 2/3) drug development clinical studies required.
• Experience with or exposure to the development of biologic therapies is desirable.
• Previous regulatory submission experience a plus (e.g., NDA, BLA, etc.)
• Strong understanding of early clinical development, dose escalation methodologies, safety monitoring, and translational medicine principles.
• Experience reviewing and interpreting clinical safety, efficacy, PK/PD, and biomarker data.

Preferred Qualifications

• Clinical training, board certification, or board eligibility in Rheumatology or related specialty preferred.
• Experience with biologics, monoclonal antibodies, or immune-mediated inflammatory diseases.
• Prior Medical Monitoring experience is strongly preferred.
• Experience supporting IND submissions and early regulatory interactions preferred.
• Experience working within small or emerging biotechnology companies preferred.