Job ID: 104043423

Job Description

Reporting to the VP of Clinical Development/CMO, the VP, Clinical Development will have overall responsibility for the strategic and operational aspects of an Omeros development program.


Who is Omeros?

Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.

Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) 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 and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has 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 proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.

What are your job responsibilities?

  • In conjunction with Marketing, Regulatory and CMC, you will define the development strategies for an Omeros clinical development program, including identifying clinical indications, appropriate drug product forms, and regulatory (procedural and geographic) options for rapid marketing approvals and label extensions
  • Interacting with global regulatory agencies in order to define efficient approval pathways
  • Supporting Medical Affairs in global medical meetings related to the development program therapeutic area
  • Establishing and developing relationships with Key Opinion Leaders in the clinical development plan therapeutic area of interest
  • Providing leadership and management oversight for all clinical research and development operations related to that program as well as overseeing the development and implementation of effective clinical development plans
  • Developing and implementing the development and implementation of clinical protocols, directly and through staff
  • In conjunction with Regulatory Affairs, assuring that all protocols and clinical trial databases are fully compliant with FDA or any other governing regulatory agency
  • Providing hands-on leadership and guidance to multidisciplinary project teams in the development and implementation of an Omeros clinical development program
  • Overseeing biostatistical staff for the analysis and review of safety and efficacy data from the assigned clinical program and being responsible for the product safety evaluation in that program
  • Identifying, evaluating and developing new clinical collaborations and alliances necessary to support Omeros strategic and operating plans
  • Supporting corporate development in the review of new product candidates available for in-license or acquisition
  • Recruiting, hiring and training additional staff to advance the organization’s portfolio

What experience and education do you need?

You’ll need to have an M.D. (Medical Doctorate) degree with a minimum of 3 years of clinical practice experience; internal medicine background is preferred. Additionally, a background from the biotechnology/pharmaceutical industry with experience and success in the development of FDA-approved therapeutic products along with 10+ years of drug development experience is required.  In addition we are seeking:

  • A proven track record in successful late phase clinical trial design and implementation
  • A strong history of global regulatory interaction, particularly FDA and EMA
  • Prior experience with successful NDA preparation
  • A thorough knowledge of regulatory requirements, gained through direct experience with the NDA approval process

 

What skills does our ideal candidate have?

As our ideal candidate, you’ll need the follow skills and knowledge:

 

  • Strong communication and presentation skills as well as excellent written skills
  • Strong interpersonal skills
  • Demonstrated ability to build and maintain positive relationships with management, peers and subordinates
  • Proven leadership skills and experience in managing diverse personalities and functions with an end result in achieving a successful integration of the team with positive results
  • Strong analytical and problem solving skills
  • A detail orientation
  • Integrity

What else do you need to know?

  • Extensive global travel is expected.

 

If you have had the responsibility of leading and developing clinical development programs, including the strategic and operational aspects, along with the skills, knowledge and experience we are looking for, we’d love to hear from you!

All interested applicants should apply at:  Omeros.com, About Omeros, Careers.  This will route you to our online applicant tracking system.

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 click to view or contact Omeros, asking for Human Resources, at click to view.

 

 

 

 

 

 

Already a Member? Sign In
Apply to this Job
(optional)
Verify you are not a robot.
By applying to this job, I agree to iHire's Terms & Conditions and Privacy Policy
COMPANY OVERVIEW

Omeros Corporation

Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Part of its proprietary PharmacoSurgery® platform, the...
Show More

View all 2 jobs
Similar Jobs

Senior Manager, Pharmacy Benefits
Seattle, WA

Clinical Pharmacy Manager Acute Care Hospital
Everett, WA

Pharmacy Manager
Kirkland, WA

Pharmacy Manager
Bellevue, WA

Pharmacy Manager
Tacoma, WA