What are the responsibilities and job description for the Senior Medical Director position at Advanced Clinical?
Overview
Our client is seeking an experienced physician drug developer to provide clinical leadership across an expanding RNAi therapeutics portfolio. This role will primarily lead autoimmune liver disease programs while supporting additional therapeutic areas and development stages as the pipeline evolves. The position drives clinical strategy, operational excellence, and cross-functional collaboration from early development through regulatory approval.
Key Responsibilities
- Serve as the strategic clinical lead for hepatology programs.
- Develop and execute innovative, practical clinical development strategies to support global regulatory approvals.
- Oversee clinical trial conduct, safety, timelines, and key deliverables.
- Advise research teams on clinical feasibility and proof-of-concept study design for novel targets.
- Collaborate cross-functionally with Preclinical, Regulatory Affairs, Medical Affairs, Clinical Operations, Biostatistics, Commercial, and QA to ensure integrated development plans.
- Lead major written deliverables, including regulatory submissions, publications, abstracts, and presentations.
- Review and approve key clinical documents (protocols, IBs, informed consent forms) in line with SOPs.
- Represent Development at regulatory interactions, scientific meetings, and external collaborations.
- MD or PhD with strong research background and peer-reviewed publications; board certification or specialist training preferred.
- 10 years of industry or equivalent clinical academic experience.
- Proven leadership of Phase 2/3 clinical programs and regulatory interactions.
- Experience in hepatology (autoimmune liver disease) preferred.
- Strong expertise in clinical research, trial design, biostatistics, and regulatory requirements.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Experience working with biotech/pharma partners is a plus.
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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
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