Responsible for planning, establishing and ensuring an integrated Clinical Development growth strategy, working in conjunction with Preclinical, Clinical Operations, Program Management, CMC, Regulatory, Medical Affairs and Commercial functions.
Designs, plan and develop the clinical trials and ensures effective implementation to advance product development.
In conjunction with the Chief Scientific Officer (“CSO”), interact with external medical/scientific advisors, thought leaders and clinical investigators, as well as with internal management and development staff to prepare/revise/maintain and efficiently execute the clinical drug development plan.
Facilitate clinical trials in conjunction with CSO and Clinical Operations by, among other activity, contributing to the design of clinical studies, contributing and coordinating the writing and updating of clinical study protocols, reviewing clinical study data and performing analyses in conjunction with Biometrics, establishing good working relationships with investigators, providing guidance and/or training for external personnel/parties involved in Otonomy’s clinical studies, contributing to the writing of clinical study reports and facilitate, assist and/or participate in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers.
Act as lead drug development plan advocate, in partnership with the CSO, with internal and external audiences. Partner with leadership to develop external advocates for Otonomy’s technology, products, and direction.
Demonstrate a thorough understanding of both clinical and commercial strategies and priorities. Maintain relevant clinical and technical expertise by, among other activity, reviewing scientific journals, attending scientific and key technical meetings and partnering with company medical, research and business teams. Proactively provide feedback on emerging clinical/competitive trends. Provide clinical education support for internal customers.
Maintain positive professional relationships with the medical community in general and especially in the otology/ENT specialties and identify emerging medical and health care practices important to the company’s business. In conjunction with Medical Affairs, develop and maintain relationships with Key Opinion Leaders (KOLs) in all matters critical to successful KOL support for Otonomy’s programs.
Contribute to the writing and updating of Investigator Brochures, IND annual reports, and annual reports to regulatory agencies.
Other duties as assigned.
NATURE AND SCOPE
Interacts with all levels of personnel internally and externally requiring the ability to clearly understand and communicate verbally and in writing Company's product development, clinical and commercial strategies, objectives and policies. Requires in-depth knowledge relevant to the applicable field. Job encounters problems of broad scope and high complexity with frequent variations from the norm. The incumbent determines own practices and procedures and develops new concepts and policies. Errors in work could cause severe delays and financial loss.
Ph.D., Pharm.D., or M.D. with a minimum of 3 years clinical drug development-related experience or Masters degree in a relevant field with a minimum of 5 years clinical drug development-related experience.
Applicant must have hands-on clinical trial experience in industry; experience in specialty therapeutic areas is strongly preferred.
Demonstrated success establishing, communicating and driving a vision and strategy for a therapeutic area/product and develop an integrated plan of action including milestones and endpoints and ensure executional excellence.
Proven experience setting strategy and implementing operational plans is important.
Excellent verbal and written medical and scientific communication skills, effective public presentation skills and strong interpersonal skills, including the ability to interact effectively with collaborators, key opinion leaders, and colleagues, who may have different levels of technical knowledge and understanding and/or differing opinions.
Demonstrated ability to remain organized and to wear multiple hats in an at times ambiguous, fast-moving environment. Capable of implementing new ideas, programs and motivating colleagues to produce effective results, while working in a hands on working environment.
Typically works in an office environment. May, on a continuous basis, sit at desk for a long period of time, intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. Must be flexible to work varying schedules and hours as needed. Frequent out of town travel may be required of approximately 20%. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.