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JOB SUMMARY: Innovent Biologics is currently seeking an experienced and energetic individual to oversee our clinical trials as Executive Director or Vice President of Clinical Development. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: • Responsible for the design and reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for approval of products. • Act as medical director on selected product development candidate programs. This includes designing clinical trials and an overall clinical development strategy leading to global product registration. • Interpret results of Phases 1 – 3 clinical investigations in preparation for new drug applications to relevant regulatory authorities. • Develop, draft and/or review clinical study reports and manage the presentation of key clinical findings to internal and external constituents. • Provide clinical development support for company activities and manage physician consultants and collaborators in the clinical research program. • Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future product candidates (internally and externally developed). • Establish productive, interactive relationships with key internal departments, as well as the medical and scientific community. • Help represent the Company as needed as a senior medical spokesperson to a variety of scientific, business and government groups/agencies. • Additional duties and responsibilities that may be assigned from time to time QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The qualifications listed below are representative of the knowledge, skill, and/or ability required or desired. • Strategic thinking skills; able to generate ideas and opportunities and turn them into successful results. • Effective interpersonal skills: one-on-one and in groups. • Able to represent the Company in a variety of internal and external settings. • Comfortable and adept at managing an environment with rapidly changing organizational needs. • Persuasive, effective and flexible in personal interactions at all levels of the organization. • Possesses enthusiasm, credibility and commitment; is genuine and empathetic . • Entrepreneurial spirit, initiator, and generator of positive group dynamics. • A team player/builder with the ability to grow and assume greater responsibility. EXPERIENCE • Management of clinical trials (Phases 1 – 3) • Experienced in building personal collaborations, networks and teams inside and outside of the organization. EDUCATION, CERTIFICATION, LICENSES and/or REGISTRATIONS • M.D. with specialty training, preferably oncology. • 3 years experience related to the clinical development and regulatory approval of human therapeutics (drugs and/or biologics) |
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