Working in a fast-paced, high energy, entrepreneurial environment, the Director of Clinical Development will play an important role in working with the team to develop strategic clinical approaches for the global clinical development of products. Tasks include assisting on the preparation of clinical development plans, research, and execution, and leading and participating on development teams.
◾Collaborate on the development of selected compounds on the implementation of strategies to achieve key objectives and milestones.
◾Assist with clinical development planning and oversee trial design and protocol development to achieve optimal speed, quality and economy for the lead programs spanning preclinical through Phase IV include managing activities of clinical research organizations or CROs.
◾In cooperation with regulatory co-workers, represent and manage the company’s clinical programs to regulatory authorities and corporate partners lead the preparation of the clinical sections of Regulatory filings.
◾Apply a blend of strategic skills combined with a practical, hands-on approach to ensure the timely execution of development plans including oversight of CROs.
◾Provide medical and specialty expertise for safety surveillance of clinical studies.
◾Build partnerships and relationships with the scientific and medical community including international scientific and professional organizations in the field of Pulmonology and Infectious diseases.
◾Working with the senior management team, play a key role in establishing, maintaining and managing collaborations with strategic partners.
◾Work closely with business development, technical operation, research, legal and other members of the senior management team to optimize the Company’s intellectual property portfolio, and provide support on technical due diligence and development associated with licensing, acquisitions and collaborations.
◾Represent the drug development group externally in scientific presentations, conferences and industry groups.
◾Contribute to the positive, success-oriented, high performance culture that reflects Insmed’s values and attracts/retains talent.
◾Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.