Medical Monitor IV- #26-25974
About The Position
Provide clinical development support across late-stage programs, focusing on the generation, review, and interpretation of clinical data and preparation of clinical documents. Work with internal clinical development team members, biometrics, regulatory, pharmacovigilance, and CRO partners to support clinical trial execution and reporting, as well as related regulatory deliverables. The role contributes clinical and scientific input to program activities and strategy, reviews clinical trial data, supports data cleaning and issue resolution, and contributes to safety and efficacy analyses. It also supports the development and review of study documents and provides clinical input on study conduct and protocol interpretation. The Medical Monitor serves as a clinical development point of contact for CROs and external vendors, supports oversight of their deliverables, participates in safety review activities, and provides clinical input to safety documents and benefit-risk assessments. Additional support may include compound-wide or cross-program documents, regulatory activities, internal reviews, and inspection readiness.
Requirements
- Physician with at least 5 years of drug development experience.
- Proficiency in clinical data review and interpretation.
- Experience authoring and reviewing clinical and regulatory documents.
- Ability to collaborate with cross-functional teams and CRO partners.
Nice To Haves
- Experience in nephrology and/or immunology.
Responsibilities
- Provide scientific and clinical input across programs in collaboration with internal team members and CRO partners.
- Review and interpret clinical trial data to inform program decisions and regulatory documentation.
- Participate in cross-functional clinical development meetings and contribute to program strategy discussions as needed.
- Review and interpret clinical trial tables, listings, and figures.
- Support data cleaning, medical data review, and issue resolution with CROs and internal teams.
- Contribute to safety and efficacy analyses, including post hoc and exploratory analyses as appropriate.
- Author, review, and finalize clinical and regulatory documents, including Clinical Study Reports, integrated summaries of safety and efficacy, Investigator’s Brochure updates, DSURs, compound-level safety documents, and clinical sections of regulatory submissions and briefing documents.
- Draft or review study-level narratives and support narrative review for submission readiness.
- Contribute to the development, review, and amendment of protocols, informed consent documents, statistical analysis plans in collaboration with Biometrics, clinical trial plans, and related supporting documents.
- Provide clinical input on study conduct questions and protocol interpretation during trial execution.
- Serve as a clinical development point of contact for CROs and external vendors.
- Participate in regular CRO meetings about protocol-related questions, data review issues, and trial conduct.
- Support oversight of CRO deliverables related to clinical data, reports, and submission documents.
- Participate in Safety Review Team meetings and routine interactions with Pharmacovigilance as needed.
- Review safety data and support evaluation of emerging safety signals with safety colleagues.
- Contribute clinical input to safety-related documents and benefit-risk assessments.
- Support preparation and review of compound-wide and cross-program documents as needed.
- Provide ad hoc clinical development support for regulatory activities, internal reviews, or inspection readiness.
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What This Job Offers
Career Level
Senior
Education Level
No Education Listed
