Our Employment Philosophy
Because the quality of Otonomy’s employees is the key to our success, we carefully select each new employee. We are committed to developing products that will benefit people’s lives and build value for our shareholders. As a team, we value honesty and integrity, knowledge, initiative and leadership, and a commitment to quality and improvement in everything we do. We want our decisions and actions to demonstrate these values. We treat one another with respect and take pride in the significant contributions that come from teamwork and the diversity of our organization. We strive for excellence and sound, responsible decision making. We know that Otonomy’s success depends on the performance of each member of our team.
When filling open positions, we will always strive to select the most qualified candidate and will not engage in unlawful discrimination based on race, color, religion, sex, national origin, ancestry, age, medical condition, sexual orientation, gender identity, gender expression, marital status, pregnancy, physical or mental disability, veteran or other protected status. Applicants who require a reasonable accommodation in order to apply for an open position are encouraged to contact Human Resources at 619-323-2200 or email@example.com. We are proud to be an Equal Opportunity Employer.
Notice to Search Firms/Third Party Recruitment Agencies (Recruiters)
Because the Human Resources team manages the recruitment process for Otonomy, to protect the interest of all parties involved, Otonomy will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Otonomy from recruiters do not constitute any type of relationship between the recruiter and Otonomy and do not obligate Otonomy to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring managers or employees.
Senior 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.
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
Apply for Senior Director, Clinical Operations using the link below: