Careers

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.

Current Openings

Technical Operations

Manager, Technical Operations

The Manager, Tech Ops position will lead technical efforts in manufacturing process development, scale up, optimization and validation. Identify, screen and provide technical guidance in selecting contract manufacturing organizations (CMOs). Manufacture drug products to support clinical development programs. Lead process transfer activities to new suppliers. Prepare technical documentation for regulatory filings. Manage manufacturing activities at the CMOs related to process development. Lead manufacturing process validation activities for drug products and drug substances. Work closely with quality assurance and regulatory groups to ensure compliance to GMPs and regulatory filings. Prepare, review and edit technical protocols and reports. Support clinical development efforts by providing GMP drug product for clinical trials. Write and review regulatory documents to support regulatory filings.

Qualified applicants will have the following:

  • B.S., or M.S. Pharmaceutical Sciences or a related discipline, or an equivalent level of knowledge and experience.
  • At least ten (10) years’ experience post-B.S. degree, seven (7) years’ experience post-M.S. degree in product development.
  • At least 3-4 years of experience in GMP manufacturing of drug substance and drug product, working with contract manufacturing facilities, particularly late stage development products.
  • Experience in manufacturing sterile drug products is strongly preferred.
  • Thorough understanding of regulatory requirements applicable to manufacturing of clinical and commercial products.
  • Excellent analytical and problem solving skills are required.
  • Excellent communication skills are essential.

 

Facilities Manager

The Facilities Manager is responsible for the design, planning, construction and maintenance of Otonomy equipment, machinery, buildings and other facilities. The incumbent plans, budgets and schedules facility modifications, including estimates on equipment, labor materials and other related costs. He or she ensures organizational goals are met by maintaining facilities and/or manufacturing machinery in excellent working condition at all times.

ESSENTIAL FUNCTIONS

  • Partners with business and construction partners to elicit, analyze, translate, and document business requirements into facilities requirements. Ensures quality and traceability to requirements and adherence to all quality management plans and standards.
  • Reviews progress against established goals and provides status reports to management as needed.
  • Coordinates the project resources needed to ensure that facilities projects are delivered on time and within budget.
  • Oversees the coordination of building space allocation and layout, and facility expansions.
  • Plans budgets and schedules facility modifications, and provides the associated cost estimates.
  • Inspects and reports status of construction and installation progress.
  • Initiates and maintains planned maintenance programs for a variety of facility equipment, including HVAC and office equipment.
  • Assists the Office Manager in maintaining the stocking, cleanliness, and order of kitchenettes, copy rooms, training rooms, and other common areas.
  • Manages the shipping and receiving function.
  • Oversees the parking and offsite storage program.
  • Oversees the cleaning and maintenance of all company facilities.
  • Develops and administers the annual Facilities Department budget.
  • Manages the Facilities Help Desk support function, and the building management systems (BMS), computerized maintenance management systems (CMMS). and/or enterprise asset management systems.
  • Manages and maintains the company’s physical security and environmental monitoring systems, taking all necessary and approved actions to safeguard Otonomy employees, contractors, and assets.
  • Supervises various contracting crews, including parking attendants, janitors and building maintenance personnel.
  • Maintains the company’s environmental health and safety program (EH&S), directs the activities of EH&S contractors or staff, and manages the company’s hazardous materials (Hazmat) program.

May perform other related duties as required and/or assigned.

Qualified Applicants will have the following:

  • Bachelor or Associate’s degree with technical training in plant engineering or factory/plant maintenance, or eight years of relevant experience.
  • Over eight years of direct, hands-on facilities maintenance experience in the following areas: electrical, plumbing, security, BMS/HVAC, carpentry, lab utilities (gases and RO/DI), and refrigeration.
  • Three years of experience supervising contracting crews and building maintenance staff preferred.
  • Excellent written and oral communications skills to maintain and write reports, work orders, and procedures.
  • Familiarity with common BMS and CMMS systems, ideally to include Johnson Metasys Controls and IBM Maximo.
  • Ability to use standard Microsoft Office software applications.
  • Ability to read schematics and diagrams.
  • Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline-driven work environment.
  • Ability to communicate in a proactive and solutions-focused manner, ensuring management is kept aware of potential issues.
  • Proven ability to make judgments, prioritize work, and accomplish goals.
  • Knowledge of FDA GxP manufacturing, clinical, lab, and basic chemical safety regulations and procedures.
  • Familiarity with EH&S regulations, local building codes, disaster recovery procedures, wastewater and hazmat handling programs.
  • Ability to work independently and manage time effectively without continual oversight or supervision.
  • Possess and maintain a valid driver’s license and good driving record.

This position is located in our San Diego office.

technical-operations

Research

Senior Research Associate, Drug Target Biology (San Diego)

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 vitro cell 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.
research

Regulatory and QA

Quality Assurance Manager (GLP/GCP)

This role will work with other members of Quality Assurance Clinical Operations and R&D to ensure GCP and GLP compliance across all levels. Provide expertise and guidance on GCP and GLP regulations, standards and quality systems. Contribute to and support the company’s R&D efforts. Essential functions of the QA Manager role include conducting internal and external audits to ensure compliance with current Good Clinical Practices (GCP) and Good Laboratory Practices (GLP); developing proactive approaches to implement quality standards, policies and procedures for GCP/GLP regulatory compliance; facilitating GCP/GLP training of functional areas and/or develops training sessions. QA Manager will also participate in regulatory agency inspections of clinical studies and GCP inspections and follow-up to resolve audit findings.; provide guidance on interpretation and application of GCP/GLP regulations and guidance documents; provide input to the preparation of documents for internal reports, external partner reports and/or regulatory filings, as needed. Other duties as assigned/required.

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/GLP.
  • Comprehensive knowledge of GCP/GLP 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.

 

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Preclinical Development

Associate Scientist Preclinical Development, Bioanalytical (San Diego)

The Associate Scientist role is responsible for contributing to the bioanalytical investigation of therapeutic targets and candidate molecules of disorders of the ear; developing, designing, conducting and analyzing in vivo pharmacokinetic studies of drug candidates and report findings. The Associate Scientist role includes work on bio-analytical methods focusing on biologics using LC/MS/MS, ELISA and other relevant assays, as well as leading technical efforts in characterization and optimization of formulations. The role will also develop, and execute bioanalytical experiments, support pre-clinical efforts by designing and conducting laboratory studies, actively contribute to project and program teams and provide clear and consistent communication of ideas, data, conclusions and outcomes. The Associate Scientist will contribute to manuscripts for key publications (abstracts posters, presentations) consistent with the overall scientific and medical communications plan, as well as present data and findings internally and externally as requested.

This position is located in our San Diego offices.

Qualified applicants will have the following:

  • B.S. or M.S. degree in Analytical chemistry, Pharmaceutical Sciences, Drug Metabolism or related discipline is required.
  • 5+ years of experience in a comparable role with a biotechnology or pharmaceutical company or a combination of academia and industry required.
  • Comprehensive knowledge of current practices in bioanalytics relating to biologics.
  • Experience with small molecules and nucleic acid based pharmaceuticals a plus.
  • Ability to manage and execute on multiple and competing priorities is expected.
  • 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.
  • Ability to work as a team member are essential.
  • Background in Otology preferred.

Senior Research Associate Preclinical Development, In Vivo (San Diego)

The functions of the Senior Research Associate (SRA) will include conducting and analyzing in vivo experiments, reporting findings, submitting recommendations and designing new experiments and approaches. In this role, the SRA will conduct and assist scientists in designing and analyzing in vivo experiments in the area of disorders of the ear, produce data and graphs to support scientific findings, draft technical reports, quantitative analyses, and other on-going documentation of assigned projects. The SRA will present data to his/her supervisor and at internal and external meetings as requested. The SRA will participate in the development of data utilized in the completion of research grants and/or patent applications, maintain a functional knowledge of the theories and techniques of an experienced SRA in the In Vivo Pharmacology field and share knowledge with peers and others. The SRA will also perform other related duties as required and/or assigned and may train and mentor junior staff.

This position is located in San Diego.

Qualified applications will have the following:

  • B.S. or M.S. degree in Biology or a related discipline.
  • At least three (3) years of applicable experience with a B.S. degree; 0-2 years’ experience with an M.S. degree, preferably in an industrial setting.
  • Hands-on experience in animal surgical procedures, in vivo efficacy assessments, and in vivo toxicity required.
  • Ability to manage and execute on multiple and competing priorities is expected.
  • Strong communication skills and the ability to work as a team member is essential.
  • Background in Otology is preferred.

 

preclinical-development

Pharmaceutical Development

Research Associate, Pharmaceutical Development

This Research Associate role will develop phase appropriate analytical methods to support Otonomy’s development programs, such as HPLC, dissolution/drug release USP apparatus, spectroscopic techniques, etc. 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. Support the oversight of analytical development, method validation, and product testing at CROs and internal drug product specifications. Essential functions include the support of pre-clinical and clinical development efforts by conducting laboratory studies; writing analytical test methods, protocols and reports; prepare, review and edit technical reports, quantitative analyses, protocols and other documentation and summaries of findings; and maintaining proper documentation of all experimental procedures and results. May perform other related duties as required and/or assigned.

Qualified applicants will have the following:

  • Minimum of B.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering or related discipline is required. Advance degree is preferred.
  • At least five (5) years of applicable experience with a B.S. degree; three (3) years’ experience with an M.S. 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.

This position is located in our San Diego office.

pharmaceutical-development

Medical Affairs

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.
medical-affairs

Commercial

Otology Sales Specialist (Boston)

Otonomy periodically searches for additions to its top notch sales team as it expands its territory presence across the United States.  While we do not currently have openings for Otology Sales Specialists we do maintain resumes of qualified candidates for consideration for future openings.

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.

Requirements include a BS degree in business or the sciences preferred, or the equivalent education and experience required.  Qualified candidates will also possess a minimum of 5+ years of recent hospital sales experience, preferably in the relevant territory/accounts; sometime of which must ideally be with a growth stage biotechnology company. 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. Sales experience in a diagnostics and/or medical device company helpful. Must reside in Western Massachusetts, Boston, MA or Hartford, CT.

To Apply: Please send your resume with salary requirements to humanresources@otonomy.com or mail to 6275 Nancy Ridge Drive, Suite 100, San Diego, CA 92121, Attention: Human Resources.  Please note: we will not respond to your resume submission unless we have a suitable opening for which you are qualified.  Thank you.

Otonomy is an Equal Opportunity Employer

commercial

Clinical

Clinical Research Associate II East Bay (Alamo Office)

This leader will be responsible for supporting the initiation, monitoring and close-out activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols under the direction of a Lead CRA or PM. In this capacity, he or she will act as the point person and the lead in the clinical/financial reporting requirements, be an active member in the review of clinical protocols, CRFs, associated study documents/plans and reports in collaboration with the clinical team and support Lead CRA or Project Managers in all CRO/vendor activities, evaluate vendor proposals to align with protocol and other budgets, and conduct feasibility assessments to identify, evaluate and select investigators and ensure adherence to study specific protocols, procedures and project plans as well as regulatory requirements. In addition, this leader will coordinate clinical site monitoring activities and participate in trip report review and tracking associated with initiation, interim, close-out and audit visits, serve as a resource for study coordinators, and coordinate Clinical Study Report Reviews with internal and external team members. Also, this leader will Assists in the design, implementation and training of electronic platforms for the TMF, PROs, IVRS, Date Management and Finance.

This position reports to VP, Clinical and is located in the Alamo Facility (East Bay).

Qualified applicants will have the following:

  • A BS or degree in a relevant scientific discipline or a related field, or equivalent education and experience.
  • A minimum of 3 years’ relevant experience with clinical studies in a clinical site or sponsor setting.
  • A broad understanding of clinical site/study operations and in-depth understanding of the drug development process, clinical trial conduct and execution, Good Clinical Practices, ICH Guidelines, PhRMA code, CFR and FDA Regulations, clinical research ethics, HIPAA and patient privacy laws as well as EU directives and other applicable local regulations.
  • Excellent organizational skills including teamwork, problem solving, customer service and presentation skills.
  • The ability to work effectively with vendors and personnel at clinical sites, and to multi-task and prioritize multiple projects, site questions, CRA questions, and clinical team inquiries with efficient accurate output.
  • Experience with EDC, IVRS and electronic TMFs systems preferred.
  • Strong oral and written communications and advanced computer proficiency.
  • Travel required up to 60% time, including potential international travel.

Clinical Research Associate East Bay (Alamo Office)

The Clinical Research Associate is responsible for supporting the initiation, monitoring and close-out activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.   The role participates in clinical trial operations,  including participating in the design and review of clinical protocols, CRFs, associated study documents/plans and reports in collaboration with the clinical team, conducting feasibility assessments to identify, evaluate and select investigators, preparing informed consents and associated study documents and coordinating clinical site monitoring activities as well as assisting in data review and the preparation of reports.   The role will also assist with the office management duties. The Clinical Research Associate role is located in Otonomy’s Alamo Office (East Bay).

A Bachelors Degree in Science or a related field is required, although highly applicable experience may be substituted for a degree.  A qualified candidate will have a minimum of 3 years’ relevant experience with clinical studies in a clinical site or sponsor setting, demonstrates a broad understanding of clinical site/study operations and have a strong working knowledge of medical scientific terminology, knowledge of FDA Regulations and ICH/GCP Guidelines.  Advanced computer proficiency as well as excellent organizational skills, problem solving proficiency, and customer service and presentation skills are a required, as is the ability to multi-task and prioritize multiple projects, site questions, CRA questions, and clinical team inquiries with efficient accurate output.  Experience with EDC, IVRS and electronic TMFs systems preferred.  The role requires travel, up to 60% time, including potential international travel.

This position is located in the East Bay, Alamo office.

clinical

To Apply

Please send your resume with salary requirements to careers@otonomy.com or mail to
6275 Nancy Ridge Drive, Suite 100, San Diego, CA 92121, attention Human Resources.

Otonomy is an Equal Opportunity Employer