In this role, the Medical Director – Clinical Development will lead the clinical development strategy of the products under his/her responsibility. He/she will be responsible for designing and executing clinical development plans across the global businesses. As such, individual will have extensive cross-functional interaction within the Company, ranging from pre-clinical through to clinical, regulatory and commercial functions.
Essential Responsibilities
• To provide clinical leadership in cross-functional projects and product/project teams;
• Responsibility for developing and maintaining the overall medical strategy of the assigned product(s), for validating this strategy with appropriate internal or external experts and for agreeing the strategy with the appropriate internal business stakeholders;
• To be responsible that project activities and milestones are planned, agreed and achieved according to the overall clinical development plan (it includes pre and post marketing activities);
• To be responsible for the timely and accurate completion of project documentation such as protocols, amendments, case report forms and study reports;
• Verifies scientific accuracy of safety and efficacy summaries for regulatory/ commercial purposes and assists with the clinical sections of regulatory dossiers and or product specific scientific discussion, depending on pre or post-marketing activities;
• Working with the Quality Assurance, Regulatory Affairs and Pharmacovigilance teams to establish and maintain strong risk assessment and management processes for decision-making;
• Input into Risk Management reviews as it relates to patient safety, the performance of risk assessment in the design of new products, and the interpretation of patient safety and risk in the post-market environment;
• Collaborating with multiple functions to ensure patient safety, minimize risk, select products for development;
• Work with teams and outside experts to design clinical development plan and to support clinical research strategies for regulatory approval, reimbursement and adoption.
Desired Skills and Experience
Qualifications/Requirements
• Medical Degree;
• Substantial experience in Pharmaceutical, Biotech, Contract Research Organization or Medical Device industry;
• Some experience in GCP Clinical trials;
• Excellent interpersonal, organization, communication, & influencing skills
• Experience managing complex projects and/or across global regions desirable;
• Good team player with global mindset;
• Ability to work independently and with rigor;
• Good process knowledge, experience, and skills
• Customer savvy and understanding of Clinical and Industry environment
• Technically savvy with experience in risk management
• Must be willing to travel as required;
• Prior experience working with Microsoft office products (Word, Excel, PowerPoint, Outlook);
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