Medical Director
hace 4 meses
These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
**Location**: Europe
**Workplace**: Hybrid/Remote
**Experience**:(all levels) Associate Medical Director / Senior Medical Director
**Qualifications**: MD Degree
**Therapeutic Expertise**:Oncology
**The Medical Director (Oncology) is responsible for the following tasks**:
Medical Affairs Management
- Independently provide medical monitor support to assigned clinical trials, for example answering medical questions from trial team and/or site, assist with protocol interpretation and medical review of generated data including but not limited to clinical laboratory data and case report forms as necessary to ensure adherence to the protocol, consistency and scientific validity of the data. When appropriate, and with the necessary support from senior colleagues, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen
- Provide input on:
- Protocol design
- Strategic clinical recommendations
- Prepare the Medical Monitoring and other relevant plans for assigned trials conducted by Allucent prior to the start of the trial and in accordance to deliverables contracted.
- Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
- Assist clinical data management with MedDRA and WHO coding in assigned trials
- Assist by reviewing clinical trial documents for medical consistency and relevance, with support of senior medical team members if needed, including but not limited to the clinical trial protocol (CTP), the Informed Consent (ICF) and clinical trial report (CSR) other safety reports (e.g., DSUR, PSUR)
- Assist in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
- Attend, participate and present in Kick-Off, Investigators’ meeting, and other relevant meetings in assigned projects, as requested.
- Provide 24/7 urgent medical support for medical and safety advice if required
- Training of project teams on medical aspects of the trial and therapeutic training as required
- Support protocol deviation guidance development and review of Protocol Deviations
- Identify trial risks and provide input to the Risk plan
- Ensure conduct of safety reviews to identify data issues, to evaluate data for safety and efficacy and to interpret trends including support to signal detection and evaluation strategies and risk minimization measures with support from senior colleagues
- Independently review and understand trial medical deliverables laid down in the assigned trial’s contract and track budget spent throughout their assigned trial(s)
- Draft and contribute with the support of senior colleagues as Subject Matter Expert (SME) in the field of Medical Monitor activities to the evaluation/improvement of processes and procedures within the Quality Management System
- Assure good communication and relationships with (future) clients
- Support Business Development efforts with support of senior colleagues by reviewing the proposal and attending client meetings including Bid Pursuit Meetings
- May advise and assist clients on product development, trial designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Allucent. Liaise with country managers and department heads at Allucent as needed to meet this task
- May provide therapeutic consultation in support of the scientific, medical, and regulatory operations of the company, including medical assessments on a consultative basis for post marketing activities (e.g., product labelling, health hazard evaluations, etc.)
Management, Learning & Development
- Active and independent support to staff learning & development within the company
- Attends and presents at major therapeutic conferences and drug development conferences and contributes to the scientific footprint of Allucent with webinars/white paper/blog posts in areas of their expertise
- Mentorship and line management role (optional) to the other medical staff within the department
- Keep up to date with developments in medical science
Quality Management
- Review, improve medical affairs processes and procedures within the Quality Management System
- Understand medical affairs department processes and procedures within the Quality Management System and ensure his/her adherence to the procedures
Account Management, Sales & Acquisition
- Assure strong long-lasting relationships with (future) key accounts
- Support in preparation of new proposals
- Contribute and take part in client evaluations, visits and bid defenses
**Requirements**:
**Qualifications**:
- MD degr
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