What are the responsibilities and job description for the Medical Monitor position at GForce Life Sciences?
Responsibilities
- Provide clinical development support across late-stage programs, including scientific review, interpretation of clinical data, and preparation of regulatory deliverables.
- Collaborate with Clinical Development, Biometrics, Regulatory Affairs, Pharmacovigilance, and CRO partners to support clinical trial execution and reporting.
- Review and interpret clinical trial data, including tables, listings, and figures (TLFs).
- Support medical data review, data cleaning, and issue resolution with internal teams and CROs.
- Analyze safety and efficacy data, including post hoc and exploratory analyses.
- Author, review, and finalize key clinical and regulatory documents, including:
- Clinical Study Reports (CSRs)
- Integrated Summary of Safety (ISS)
- Integrated Summary of Efficacy (ISE)
- Investigator's Brochure (IB) updates
- Development Safety Update Reports (DSURs)
- Clinical sections of regulatory submissions and briefing documents
- Study narratives and narrative reviews
- Contribute to the development and review of:
- Clinical protocols and protocol amendments
- Informed Consent Forms (ICFs)
- Statistical Analysis Plans (SAPs) in collaboration with Biometrics
- Clinical trial plans and supporting study documentation
- Provide clinical guidance on protocol interpretation and study conduct during trial execution.
- Serve as the clinical point of contact for CROs and external vendors.
- Participate in CRO meetings to address protocol questions, data review issues, and trial conduct topics.
- Review CRO deliverables related to clinical data, reports, and regulatory submissions.
- Participate in Safety Review Team meetings and collaborate with Pharmacovigilance on safety assessments.
- Review emerging safety signals and contribute to benefit-risk evaluations and safety documentation.
- Support cross-program documentation, regulatory responses, and inspection readiness activities as needed.
Qualifications
- MD or DO required.
- Minimum of 5 years of drug development experience within the pharmaceutical or biotechnology industry.
- Experience serving as a Medical Monitor or supporting clinical development programs.
- Experience reviewing clinical trial safety and efficacy data.
- Experience authoring and reviewing clinical and regulatory documents, including CSRs, ISS/ISE, IBs, DSURs, and clinical protocols.
- Experience collaborating with cross-functional teams, including Biometrics, Regulatory Affairs, Pharmacovigilance, and CRO partners.
- Experience supporting late-stage clinical development programs preferred.
- Nephrology and/or Immunology therapeutic area experience preferred.
- Strong clinical data interpretation, scientific writing, and communication skills.
- Ability to manage multiple priorities in a collaborative, cross-functional environment.