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 regardless of race, color, religion, sex, national origin, ancestry, age, medical condition, sexual orientation, marital status, pregnancy, physical or mental disability, veteran or other protected status. We are proud to be an Equal Opportunity Employer with commitment to Affirmative Action for Minorities, Women, Individuals with Disabilities and Veterans.
Senior Research Associate, Drug Target Biology
The functions of the Sr. Research Associate (SRA) include contributing to the investigation of therapeutic targets and candidate molecules in cochlea cells and tissue using molecular, biochemical and optical techniques to support the growth of Otonomy’s pipeline. Developing biomarkers to support the company’s applied translational research, target selection, and clinical development efforts in ear diseases. SRA will also Develop and validate testing models to assess drug-able pathways of human ear disease to evaluate the efficacy of small molecule and biopharmaceutical drug candidates, facilitate selection of relevant ear diseases for preclinical and clinical evaluation, and conduct biomarker studies of candidate drugs in animal models in close collaboration with the Preclinical Group. The SRA may perform other related duties as required and/or assigned.
This position is located in San Diego.
Qualified applicants will have the following:
- BS/BA (MS/MA preferred) in Biology, Molecular Biology, Cell Biology, Pharmacology, Neuroscience, or related discipline.
- BS/BA plus 5 years of experience or MS/MA plus 3 years of experience in a comparable role with a biotechnology or pharmaceutical company required.
- Preferred experience includes biopharmaceutical research and development.
- Comprehensive knowledge of current practices in in vitrocell and molecular biology and pharmacology research within Neuroscience, Ophthalmology and/or Otology.
- Experience in developing testing models for drug target characterization and validation, with a desire and experience in translating new biology into viable therapeutics a plus.
- Expertise in primary cell culture, assay development, automation of assays, and state-of-the-art molecular and biochemical techniques. Experience writing and submitting reports in support of regulatory submissions (INDs).
- A primary focus and experience in signaling and regulatory pathways, pharmacology or neuroscience is preferred.
- A commitment to high-quality research and the execution of research plans in a timely and organized manner.
- Excellent verbal and written communication skills as well as strong interpersonal skills, including the ability to interact effectively with collaborators, clients, vendors and personnel, who may have different levels of technical knowledge and understanding.
Regulatory and QA
Quality Assurance Manager (GCP)
The position of Quality Assurance Manager-GCP Compliance will lead and direct QA activities in the areas of GCP auditing, training, establishment and implementation of quality standards to support Otonomy’s research, development and commercial organization. This position is a member of Otonomy’s Quality and Regulatory Affairs Department and reports directly to the Sr. Director, QA. This position can be located in either our San Diego or Alamo, CA office. The QA Manager-GCP Compliance works with the Clinical, Regulatory, Technical Operations (supply chain), and other departments to provide QA oversight and management to ensure GCP compliance. Represents QA team for interactions with Contract Research Organizations (CROs) and provides input into requirements of GCP quality matters and industry regulatory standards. Assists in regulatory agency GCP inspections at Otonomy and leading GCP audits at clinical sites and contract service providers. Provides direction and guidance on the implementation and management of Otonomy’s quality and compliance program to domestic and international GCP guidelines and regulations, and company policies. Responsible for defining and meeting functional area goals and objectives as they relate to departmental goals.
This role will develop GCP-related standard operating procedures (SOPs) in compliance with FDA and ICH guidelines. Establish a GCP training program including Otonomy’s quality standards and compliance, keeping current with the GCP regulatory landscape. Provide ongoing GCP training, expectations, GCP issues, and support to Otonomy’s Clinical Department. Provide compliance assessments for trial master files (TMFs) clinical protocols, case report forms (CRFs), data collection, clinical study reports (CSRs) and other clinical documents, as required. Review and approve audit reports and Corrective and Preventive Actions (CAPAs). Provide compliance assessment, metrics, and updates to senior quality, regulatory and clinical management. Participate in the preparation of Quality Agreements/Contracts with CRO Management/Service providers, as applicable. Assist with creating/implementing GCP inspection systems and coordinating follow-up actions and responses to resolving inspection findings. Provide input into the GCP supplier/vendor qualification program, including arranging audits, drafting, audit reports, closing out audits and updating of the approved suppliers list. Manage the development and refinement of Otonomy GCP quality systems and procedures.
Qualified applicants will have the following:
- Bachelors’ degree in a scientific discipline or the equivalent education and experience.
- 5+ years of relevant experience in the pharmaceutical or biotech industry.
- Working experience in a Quality environment with expertise in GCP.
- Additional experience with Good Laboratory Practices a plus.
- Comprehensive knowledge of GCP regulations.
- Experience with documentation systems, document review and auditing responsibilities.
- Must have background working in an interdisciplinary team environment.
- Strong verbal and written communication skills and detail orientation required.
- Must be proactive, independent, hard-working and committed to achieving difficult goals.
Associate Scientist/Scientist, Pharmaceutical Development
This role will develop phase appropriate analytical methods for drugs in complex formulation matrix/drug delivery system to support Otonomy’s drug development programs. Conduct, analyze, and report on experiments to support analytical method evaluation, method transfer, study investigations as well as pre-formulation, formulation, and process development in pharmaceutical development. May need to support the oversight of analytical development, method validation, and product testing at CROs and internal drug product specifications. Support pre-clinical and clinical development efforts by conducting laboratory studies relating to product characterization, stability, and quality. Perform formulation stability studies. Write analytical test methods, protocols and reports as part of analytical transfers to CRO/CMO for GMP and non-GMP testing and make sure they are consistently implemented by the vendors. Maintain proper documentation of all experimental procedures and results. Present data at internal and external meetings. Maintain a thorough knowledge of the applicable scientific arena and routinely educate peers and others on that information. Participate in the development of data and materials for use in research grants and/or patent applications, as well as regulatory filings. May perform other related duties as required and/or assigned.
This position is located in our San Diego office.
Qualified applicants will have the following:
- Associate Scientist: Minimum of B.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or related discipline is required
- Scientist: MS or PhD degree in Analytical Chemistry, Pharmaceutical Sciences is required
- Analytical Method development experience is required.
- At least five (5) years of method development experience with a B.S. degree; three (3) years’ method development experience with an M.S. degree, one year (1) method development experience with a PhD degree, preferably in an industrial setting.
- Solid knowledge and hands on experience in various analytical techniques such as HPLC, USP dissolution testing apparatus, UV-Vis, as well as instrumentation such as particle sizers, Osmometers, Viscometers, etc.
- Ability to manage and execute on multiple and competing priorities is expected.
- Solid communication skills and the ability to work as a team member are essential.
- Great attention to details and strong ability to cope with change.
Medical Science Liaison (Bay Area, Seattle)
The Medical Science Liaison (MSL) nurtures deep, collegial relationships with key thought leaders, professional societies, and payers to ensure that the Otolaryngology KOLs/Community Physicians and the broader Payer Commercial Community is appropriately educated and enthusiastic about the clinical and scientific basis for the science, therapeutic application and clinical research behind Otonomy’s product portfolio. The MSL will also drive the adoption of tools and techniques for the safe and effective use of our products. The MSL will engage with KOLs to address medical and scientific inquiries, support Otonomy-sponsored clinical trials, and facilitate investigator-initiated clinical trials. This MSL role develops and maintains strong working relationships with medical experts in both academic and community settings to develop understanding and enthusiasm for the scientific basis for Otonomy’s product portfolio; disseminates scientific information and discusses research with physicians, nurses, pharmacists and other healthcare professionals through educational presentations, consultant programs and 1:1 peer exchange; responds to medical inquiries from healthcare professionals by providing timely, accurate, scientific data; and supports the Commercial team, in a compliant manner and consistent with our SOPs, with medical and scientific expertise as requested. MSL will also provide sales force with training at national and regional levels as requested; assist in the selection and training of KOLs participating in the commercial Speaker’s Bureau; conceptualizes and communicates requests from stakeholders through Medical Affairs to Clinical, pre-clinical, exploratory, drug safety and medical information etc; represents Otonomy at specific continuing educational events/programs, medical meetings and conventions; and facilitates and establishes research opportunities between Otonomy and clinical investigators. May perform other related duties as required and/or assigned.
The Territory for this MSL role includes: Alaska, California, Colorado, Hawaii, Idaho, Nevada, Utah
Location: This role is remote. The preferred location for the role is the Bay Area or Seattle.
Qualified applicats will have the following:
- Bachelor’s degree in a scientific or related field with relevant MSL experience is minimum requirement. Advanced Degree preferred (ie. Pharm D, MD, PH.D).
- Minimum 8 years of relevant experience in the pharmaceutical industry including:
- Previous experience educating and influencing KOLs/community physicians and the broader payer commercial community on the science, therapeutic application and clinical research behind a company’s product portfolio.
- Previous experience developing impactful presentations in a variety of settings for a variety of audiences.
- Must have a strong understanding of the hospital environment.
- Excellent communication skills (public speaking, 1:1 exchanges, written communications) as well as the ability to work collaboratively with several teams in the field such as sales and national accounts.
- Must be fully cognizant of all relevant complex scientific data and complex regulatory requirements for field-based personnel.
- Must be committed to continuing education to maintain knowledge base.
- Prior experience in the management or investigation of clinical trials is required.
This role performs a variety of finance and accounting activities including the preparation of clinical trial accruals and contract accruals. Works closely with the Clinical group to prepare clinical trial accruals. Performs contract accrual tracking and accounting. Reviews new contracts for any accounting implications and accruals. Prepares and inputs general journal entries and monthly journal entries related to areas of responsibility as required, including monthly stock compensation journal entries. Prepares account reconciliations and supporting schedules for balance sheet accounts related to areas of responsibility including support for all estimates. Provides support and prepares financial information requested by external auditors during their quarterly reviews and annual audit. Assists finance management in daily duties including addressing inquiries, researching accounting issues and interfacing with other departments; implements finance policies and procedures. Performs various ad-hoc projects or reports as required or requested by management. Ensures that accounting functions are performed in accordance with US GAAP, SOX requirements and SEC guidelines.
Qualified applicants will have the following:
- Bachelor’s degree in Business Administration, or other related discipline, or the equivalent knowledge and experience is required. Professional certification in Accounting preferred.
- Requires 3+ years’ relevant experience
- Big 4 or National CPA experience preferred
- CPA preferred
- Proficiency in MS Excel and Word; and experience with Great Plains desirable
- Must have excellent customer service attitude
- Publicly-traded company experience preferred
- Experience with Sarbanes-Oxley compliance requirements preferred
- Strong, current working knowledge of GAAP and project accounting
- Ability to collect, analyze and interpret data to produce accurate reporting
- Proven ability to thrive in a team environment, being willing to assist other team members to achieve team goals and objectives, and go the extra mile when necessary
- Ability to develop, recommend and implement procedures; excellent analytical, problem solving and organizational skills
- Effective verbal and written communication skills, and ability to effectively interact with employees in a team-base environment
Otology Sales Specialist (Oklahoma City)
The Otology Sales Specialist focuses on launching and selling novel compounds in the hospital outpatient setting. The position will also develop and implement strategies for introducing new products and growing the business with assigned accounts. The territory includes the Oklahoma City, Tulsa, Amarillo and Lubbock areas.
- Must reside in or close to the Oklahoma City area
- Meet or exceed all established territory sales plan and expense plan goals and objectives, by developing and implementing strategies specific to the assigned territory.
- Establish and maintain professional relationships with targeted opinion leaders and hospitals, including physicians, medical staff, pharmacies, etc.
- Discover who the decision-makers and key contacts are in a hospital account, and establish and maintain professional relationships.
- Develop and implement strategies to ensure products are on hospital formulary.
- Maintain and provide timely written and/or verbal communications as required by supervisor or home office.
- Effectively plan work days and sales calls to accomplish goals and objectives.
- Develop and implement special programs within territory to maximize sales opportunities, i.e. speaker’s bureau programs, symposia, etc.
- Develop and/or maintain permanent customer records.
- Complete assigned administrative tasks in a timely, accurate, and organized manner.
- Communicate a current, effective, and accurate sales presentation to customers.
- Present a professional sales image in all business matters.
- Maintain and operate assigned sales territory within established sales and/or corporate policies, procedures, and standards.
- Carry out all duties and responsibilities in compliance with applicable regulations and Pharma guidelines.
- Maintain an updated working knowledge of Otonomy products and relevant disease state.
- Maintain flexibility and ability to take on additional or alternative roles/responsibilities as required.
Qualified applicants will have the following:
- BS degree in business or the sciences preferred, or the equivalent education and experience required.
- A minimum of 5+ years of recent hospital sales experience, preferably in the relevant territory/accounts; sometime of which must be with a growth stage biotechnology. Sales experience in a diagnostics and/or medical device company helpful.
- Experience with hospital sales to ENTs and/or buy and bill background preferred.
- Must have previous experience navigating the P&T Committee/hospital formulary process as well as gaining appropriate utilization of company products by relevant MD specialists.
- Knowledge of the current hospital reimbursement/managed care environment strongly preferred.
- Excellent communication and interpersonal skills, self-motivation with a sense of urgency, well-organized, strong problem-solving abilities.
- Proven ability to establish and build relationships and rapport with a diverse customer base.
- Strong ability to learn and use technical product knowledge.
- The strongest candidates will have a proven track record in a sales environment focusing on individual accountability and will be consistent annual award winners.
- Must have a valid driver’s license.
Please send your resume with salary requirements to email@example.com or mail to
6275 Nancy Ridge Drive, Suite 100, San Diego, CA 92121, attention Human Resources.
Otonomy is an Equal Opportunity Employer