- Further ’s Xcene’s clinical development program by assisting in the design and conduct of clinical trials including the drafting of protocols and amendments.
- Be the Medical Expert (“Medical Monitor”) for assigned clinical trials which includes being readily available to advise on trial-related medical questions or problems during the conduct of the trial.
- Contribute to investigator training.
- Take a lead role in drafting the Integrated Summary of Safety and Integrated Summary of Efficacy
- Assist in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation.
- Lead medical aspects of medical monitoring. Work closely with the Pharmacovigilance and Safety representatives providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports, and preparation of labels.
- Responsible for medical monitor expertise input into the development and implementation of standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting, and assuring compliance with global and local regulatory requirements.
- Attendance at teleconferences and face-to-face meetings with global regulators. Responsible for implementing alignment across policies/procedures and ensure that data generated meet monitoring and compliance with NAFDAC, global and local regulatory ICH guidelines, and GCP.
- Additional duties and responsibilities not listed here may be required
- Africa, US, and EU experience preferred.
- Medical degree with strong leadership skills including 1-5 years direct experience in the pharmaceutical industry preferably in a medical monitoring role.
- Experience in Sickle Cell Disease and Infectious disease space preferred but all therapeutic areas will be considered.
- Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs.
- Experience providing input into key regulatory documentation.
- Excellent interpersonal and communication skills with the ability to relate to both internal and external stakeholders.
- Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
- Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
- Experience using medical monitoring software such as JReview or Spotfire.