Medical Director - Cardiac Electrophysiology
Global Medical Director - Cardiac Electrophysiology A top medical device company is seeking an experienced Cardiac Electrophysiologist to join its industry-leading Cardiac Rhythm Management business unit. As Global Medical Director, you will provide medical insights and expertise for the development and management of clinical trials and post-market studies, ensure patient safety, liaise with healthcare professionals, and help to guide/inform business strategy. This is an excellent opportunity to enter into industry in an established, leading organization and join a truly fantastic team. Requirements: Optimize the safety of Medical Devices throughout their lifecycle (pre-clinical, clinical and post-market) Provide medical guidance for product development, risk management and rick-benefit analyses, clinical trials, and post-market surveillance studies Engage with external stakeholders including regulatory bodies, study investigators, and healthcare professionals Offer support for the design and conduct of clinical trials including protocol development and trainings Contribute medical and scientific expertise towards business development strategy Regular travel will be required to company headquarters, medical conferences, investigator sites, etc. (up to Qualifications: MD or equivalent degree (e.g., MBBS); board certification in clinical cardiac electrophysiology is preferred 5+ years of clinical experience in cardiac electrophysiology; experience with cardiac ablation therapies is preferred Familiarity with clinical trial design and conduct is preferred Knowledge of with medical device regulatory processes is preferred Compensation and Benefits: Total annual compensation of $325,000 - $375,000 (base salary + bonus) Eligible for stock-based LTI package Industry-leading company culture Ample opportunities for professional development and career growth Option for remote work with regular travel to company HQ Medical, vision, dental, and life insurance 401K matching program
US$325000 - US$375000 per annum + Stock-based LTI
Minneapolis
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Clinical Scientist
The Sr. Clinical Scientist is responsible for ethical, medical, and scientific rigor in development, conduct and reporting of assigned clinical studies. Responsible for medical and scientific quality in the design, planning, initiation, and successful completion of assigned clinical trials for new or marketed drugs for all phases of clinical development. Interacts with KOLs and other external experts to ensure appropriate and rigorous study design in selected indications. Essential Duties & Responsibilities Provide scientific input to clinical studies. Write, edit, and review medical and scientific elements of clinical research, operational and regulatory documents, including but not limited to synopses, protocols, CRFs, informed consent templates, feasibility assessments statistical analysis plans, regulatory documents (eg, IND, MAA, NDA, PIP), key study plans, and clinical study reports to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency. Ensure validity, accuracy, relevance, and completeness of medical and scientific content in clinical research and regulatory documents. Lead and delegate clinical data review tasks and data analysis to ensure data quality and consistency, including the identification of data and query trends to contribute to overall data quality. Lead responses to competent authority questions, as requested. Establish and maintain quality corporate relationships with leading investigators and clinical sites on assigned protocols in collaboration with Clinical Operations team. Contribute to the development of global regulatory strategies. Provides training and support to sites and CRAs at Investigator Meetings and other events as needed. Establish and maintain effective communication and collaboration with functional area peers, including study teams, data management, biostatistics, regulatory, among others. Participate in development of publication strategies, writing and editing of draft presentations and manuscripts and interface with external vendors and authors. Support the review and approval of promotional material, labeling, and training material pertaining to assigned product. Share scientific knowledge with the organization during continuing education sessions and CRA and vendor trainings, at an adapted level of understanding. All other duties as assigned. Experience & Qualifications PhD, PharmD or MD with demonstrated industry experience in clinical research and drug development, minimum 5 years preferred experience in the biopharmaceutical industry in clinical science, clinical research, or equivalent. Experience in AD and PD or neurodegenerative diseases. Proven track record of successful protocol development, execution, and reporting in industry. Understanding of pharmaceutical business, worldwide drug development and regulatory process. Excellent interpersonal communication, collaboration, organization, and presentation skills. Solid understanding of clinical trial design, biostatistics, and data analysis. Familiarity with ICH and GCP. Strong project management skills. "Roll-up-the-sleeves" attitude.
US$120000 - US$130000 per year
Malvern
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