Medical Director
FWD People
Associate Medical Director / Medical Director
Allucent
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
- We are looking for a Medical Director to join our A-team (office-based*/remote). The Medical Director works independently to ensure the medical/clinical and safety integrity and quality of trials conducted by Allucent. Serves as the medical monitor contact in trial protocols to investigators and trial sites regarding protocol related questions and safety of the subjects enrolled. Advises investigators, project teams, and clients on safety issues arising from medicinal products, devices and trial designs undertaken by Allucent. Works along with more senior colleagues and internal team members, senior management and business development on issues and questions of any medical /clinical nature. Reviews SAEs, SUSARs and AEs reports and writes safety narratives in accordance with all applicable competent authority regulations and reporting standards. Reviews, if needed with support from more senior colleagues, protocols, investigator’s brochures, clinical trial reports written by Allucent ensuring they are approved in accordance with Allucent procedures and good medical practices. Supports Business Development efforts with support of senior colleagues by reviewing the proposal and attending client meetings including Bid Pursuit Meetings.
- Key tasks: Independently provide medical monitor support to assigned clinical trials; Provide input on Protocol design and Strategic clinical recommendations; Prepare Medical Monitoring and relevant plans; Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events; Assist clinical data management with MedDRA and WHO coding; Review clinical trial documents for medical consistency; Assist in set up and conduct of Data Safety Boards and Dose escalation meetings; Attend and present in Kick-Off, Investigators’ meeting; Provide 24/7 urgent medical support; Training of project teams; Support protocol deviation guidance; Identify trial risks and provide input to Risk plan; Ensure conduct of safety reviews; Independently review and understand trial medical deliverables and track budget; Draft and contribute as SME to evaluation/improvement of processes; Support Business Development; May advise and assist clients on product development and trial designs; May provide therapeutic consultation for post marketing activities; Assure strong relationships with key accounts; Support in preparation of new proposals; Contribute to client evaluations and bid defense; Contribute to other areas of business as required.
Requirements
- MD degree
- Minimum 5 years of relevant work experience
- Very good knowledge of GxP
- Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
- GDPR/HIPAA, CFR/CTR/CTD and applicable (local) regulatory requirements understanding
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required
