Associate Director, Clinical Operations

The Associate Director, Clinical Operations will be responsible for the operational direction and oversight of clinical development programs including timelines, budget, and resources. This person will have management responsibility for internal Clinical Operations staff, as well as external contract organizations. This position will have strategic and technical influence on drug development. This position is also responsible for formulating and executing the operational aspects of the company's clinical trial programs and other duties as assigned. This person is able and willing to perform all duties or functions of subordinates.

Good things are happening at Omeros

Come join our Clinical Operations Group!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company's drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

• Directs and oversees all clinical operation aspects of clinical trials

• Manages clinical operations personnel

• Assists with development and management of the clinical operations departmental budget

• Implements clinical development program strategies

• Develops and presents operational plans to management

• Identifies clinical program/resource gaps and devise and implements solutions

• Drives program and project risk analysis and develops solutions to a variety of complex problems

• Develops and implements clinical outsourcing strategies

• Oversees the selection and management of CROs and other vendors

• Provide operational input in the development of Clinical Development Plans (CDP) including timelines, budget, and resource requirements

• Assists in the development of Clinical Operations quality systems, including Standard Operating Procedures (SOPs), document management, Clinical Operations personnel training, and quality control processes

• Manage internal staffing and performance including hiring, training, coaching, and performance reviews

• Support Clinical Operations personnel with clinical trial management, including clinical project management, site monitoring and management, and vendor management

• Perform some or all of the Duties and Responsibilities outlined for Clinical Program Manager, as needed

• Represent Clinical Operations in corporate relationships as requested

• BS or equivalent in a scientific discipline is required

• Minimum of 4 years of clinical operations line management experience

• Minimum of 8 years of progressive experience in Clinical Operations with strong

• Strong clinical operations experience with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing

• Function management experience

• Knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trials

• Proficient in clinical studies involving complex design issues (e.g., multiple arms, crossover, double blind, and multi-center), in all phases of pre-approval clinical trials

• Strong analytical and strategic planning skills

• Matrix leadership skills

• Proven ability to provide clinical operations expertise to a clinical development program

• Must be a self-starter and team player with strong interpersonal skills

• Must have the ability to build and maintain positive relationships with management, peers, and subordinates

• Strong leadership skills; communicates and demonstrates vision and commitment

• Demonstrates effective influence and relationship management skills

• Excellent written and verbal skills required

• Must display strong analytical and problem-solving skills. Attention to detail required

• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws

• Responsibilities include interviewing, hiring, and training employees; planning, assigning, directing work, and appraising performance

• This position will also supervise work in a matrix organization

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily

• The requirements listed above are representative of the knowledge, skills, and/or abilities required

• May encounter prolonged periods of sitting

• The employee may frequently be performing repetitive movements such as typing on a keypad or using a mouse

• The employee may climb, bend, reach, push, pull, balance, stoop, kneel, or crouch

• The employee must on occasion lift and/or move up to 25 pounds

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

If you have the skills, knowledge and experience we are looking for, we'd love to hear from you!

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.