Precision, for Medicine is currently seeking a Medical Director to become part of our team; individuals can choose to work from locations such, as the UK, Spain, Poland, Hungary, Romania, Serbia or Slovakia.
Job Overview
The Medical Director acts as the project physician. Offers scientific knowledge to project teams. The main responsibility of the Medical Director is to guarantee the precision and reliability of the data generated during the trial while placing an emphasis, on safety. Additionally to overseeing development programs within hematology and oncology for clients this role plays a role, in strategic planning and execution and contributes to expanding Precisions Medical team while assisting in Business Development initiatives.
Primary Responsibilities:
- Collaborate directly with Medical, Operational Strategy, and Business Development leadership to drive client engagement.
- Support Business Development and Proposals teams; participate in the RFP process, prepare medical considerations section for proposals; support or attend bid defense meetings.
- Write scientific content of deliverables on budget and timelines or edit.
- Regulatory Product Landscape and Strategies Collaborate with Regulatory Affairs during development to ensure strategies are included as part of overall drugs development strategy.
- Contribute with scientific expertise and author targeted company publications/white papers/publication manuscripts.
- Serve as an efficient reviewer/editor of protocols, case report forms (CRFs), training materials/standard operating procedures(SOPs)/tools for project specific needs; analysis plans and study designs); clinical trial reports [CTRs] & NDA.
- Review clinical laboratory parameters, adverse events (overall listing), coded AEs and medication data for correctness & completeness as appropriate (*)(Data Table/listing/figures when necessary)
- Serve as a medical resource for study sites, project team and clients.
- once decided at the time of study preparation) and help with investigator meetings and staff training materials (e.g. agenda, metadata).
- Take the lead in monitoring aspects of clinical and safety management on assigned projects.
- Conduct discussions on the feasibility of specific project proposals
- Create training modules and deliver disease state-focused trainings.
- Engage in the process improvement campaign.
- Work with Global Medical senior Vice Presidents and others in the medical science department to partner on business planning activities across all regions.
Qualifications
Minimum Required:
- Medical qualifications- MD, DO, MBBS or equivalent
- More than five years experiencing in clinical.
- Minimum of 5 years experience in oncology clinical research.
- Proven comprehensive working knowledge of the lifecycle and drug development process in oncology through acquisition of well-practiced skills to critically review clinical trial protocols (specifically in Oncology) astrategist.
- Able to travel domestic and international; availability for required overnight stays (approximately 30% of time on the job).
Preferred:
- Experience in Oncology nonclinical drug development.
- Fellowship training in oncology or equivalent
- Oncology Board Certification or equivalent
- Background in oncology clinical trials (Phase I and II)
- Prior CRO experience.
- Stay up-to-date on the latest scientific and medical information of interest.
Skills/Competencies
- Reliability; Service oriented understanding.
- The position requires a strategic thinker who is able to create and justify strategies for drug development in unique contexts of developing innovative, new programs that differ from traditional designs or patient populations.
- Shows professionalism on the job, example punctuality; positive interaction with clientele and co workers (good people skills).
- Express clearly both in speaking and written form.
- Give formal presentations to diverse audiences, including colleagues.
- Good with visuals and presentations.
- Experience working in a high volume, fast-pacing team environment with little to no supervision.
- Experience with working from home efficient
Precision for Medicine is the first global clinical research services organization purpose-built to improve and accelerate development of new therapeutics through a suite of precision medicine solutions. This includes maintaining our world-class ability to care for patients, leveraging some of the top laboratory expertise in the nation and applying advanced data sciences at every step. Our experience is fully integrated in both oncology and rare disease from early development to approval applying these same capabilities across all stages of the trials.
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