Sr. Director, Clinical Operations
The Senior Director, Clinical Operations leads the strategy and execution to successfully work with vendors, investigators, clinical development scientists, and the program team to develop, execute and deliver clinical studies supporting Otonomy’s development pipeline, with a focus on quality, speed and cost.
- Direct and oversee clinical trials execution to ensure compliance with regulatory requirements, adequacy of data acquisition and management, and ensure timely completion of clinical studies.
- Implement all logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.).
- Monitor, communicate and manage budgets for clinical trials; negotiates fees with clinical sites and service providers.
- Nurtures, promotes, and speeds the development of high-quality high-performing study sites to support clinical trials.
- Has broad experience selecting, managing, troubleshooting and negotiating with (CRO) vendors.
- Evaluates, refines, and makes recommendations for various operational constructs for study execution.
- Cultivates a sustained and synergistic partnership with clinical investigators and institutions focused on science and clinical excellence.
- Leads strategies for patient recruitment and retention in clinical trials.
- Interacts internally and externally with executive level management requiring negotiation of complex matters.
- Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs.
- Travel is required (approximately 30%), which may include international travel.
- Other tasks as assigned.
Nature and Scope:
The job encounters problems of broad scope and moderate to high complexity with variations from the norm. The incumbent typically determines own practices and procedures and leads and/or contributes to the development of new concepts and programs. Errors in work could cause delays and financial loss.
Bachelor’s degree in the life sciences or related field. Advanced degree preferred.
- At least 10 years of related experience with significant late-stage and ex-US clinical trials experience. At least 6 years’ proven experience in a leadership and people management role.
- Practical experience in clinical trial strategies, methods and processes; deep knowledge of clinical trial execution.
- Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output, including cross-functional understanding related to drug development.
- Prior experience managing third parties and external service providers (including ex US) and consultants is a must
- Good judge of risks and a keen ability to analyze options and manage outcomes.
- Familiarity of Regulatory Affairs as applicable to clinical data and report filings.
- Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
- Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
- A good understanding of GCPs.
- Well versed with the latest trends in the clinical trial industry.
- Possess a strong commitment to quality and accuracy as a self-starter and a team-player in a fast-paced, start-up like environment.
Works in an office environment. May on a continuous basis walk, bend and lift up to 20 lbs. The noise level in the work environment is usually low. May intermittently sit at desk for a long period of time to answer telephone and write or use a keyboard to communicate through written means. Must be flexible to work varying schedules and hours as needed and travel. 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.
Equal Opportunity Employer/Females/Minorities/Veterans/Disability