Job Summary:

The Medical Director, Clinical Development – is a therapeutic and disease area specialist who will play a key role in advancing innovative therapies for patients with immunology diseases through high-quality design and execution of clinical trials. In this role, you will provide medical leadership across a range of clinical development activities, including but not limited to: study design, study execution, the monitoring of patient safety, data interpretation, and contribution to regulatory and scientific deliverables. As an internal scientific leader in the field, you will provide input into the overall clinical development strategy for the asset and incorporate insights from key opinion leader interactions into both study design and development strategy. This role involves working closely with internal cross-functional partners across a range of disciplines to drive high-quality clinical programs in a fast-paced biotech environment

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Lead and provide medical oversight for assigned clinical trials including; protocol development, study conduct, medical monitoring, data review & interpretation, and clinical study reporting.
• Contribute to clinical development strategy and program plans by integrating scientific rationale, regulatory requirements, safety considerations, operational feasibility, and business objectives.
• Provide medical leadership on trial design, including endpoint selection, eligibility criteria, dose rationale, biomarker strategy, risk-based monitoring, and interim analysis frameworks.
• Monitor real time data collection throughout study conduct ensuring robust study conduct and protocol adherence.
• Support pharmacovigilance activities during trial conduct — monitor patient safety and benefit-risk throughout study conduct through review of adverse events, serious adverse events, laboratory data, safety narratives, and aggregate safety information, and contribute to related safety governance activities in coordination with the Global PV Medical Director
• Serve as a key medical resource for investigative sites, external advisors, and clinical investigators, ensuring patients meet the appropriate eligibility criteria, responding to clinical and safety inquiries and supporting external interactions, advisory boards, and scientific communications as appropriate.
• Lead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs — sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights that inform overall development strategy.
• Review, author, and contribute to key clinical and regulatory documents, including protocols, protocol amendments, investigator brochures, informed consent forms, clinical study reports, briefing materials, and health authority responses.
• Support regulatory interactions and submissions by providing medical and scientific input for agency meetings, annual reports, and clinical sections of regulatory filings.
• Serve as the clinical development lead for an asset if required
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Advanced clinical degree (MD or DO) or MD/PhD required. Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty strongly preferred. Additional advanced degree (PhD, MPH, or MBA) is a plus.
• Minimum of 5 years of combined clinical and pharmaceutical/biotech industry experience
• Direct experience treating, or managing lupus (SLE and/or CLE)and/or systemic sclerosis patients/clinical programs strongly preferred.
• Deep scientific expertise in autoimmune disease — rheumatology, specifically lupus (SLE and/or CLE) or systemic sclerosis, preferred.
• Direct experience of phase 1-3 clinical studies in particular; authoring clinical trial protocols, clinical development plans and regulatory submission documents
• Deep clinical and scientific expertise in immunology and inflammation— including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches
• Proven ability to identify, characterize, and mitigate clinical, operational, and regulatory risks across multi-site, multinational clinical programs
• Demonstrated ability to lead and influence cross-functional teams in a matrixed, fast-paced biotech or pharmaceutical environment without direct line authority
• Proven ability to build alignment across diverse internal and external stakeholders, including senior leadership, clinical operations, regulatory, and commercial partners
• Track record of driving program-level decisions with clarity and accountability, balancing scientific rigor with business urgency in resource-constrained settings
• Exceptional scientific communication skills, with the ability to articulate complex medical and clinical data to senior leadership, health authorities, clinical investigators, and external partners.
• Demonstrated scientific writing proficiency, including the ability to evaluate and present complex data sets in regulatory documents, clinical study reports, and scientific publications.
• Skilled at facilitating high-stakes discussions — including advisory boards, cross-functional program reviews, and health authority interactions — with confidence and precision