Medical Director Sr. Medical Director, Clinical Development

Omeros

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profile Job Location:

Seattle, OR - USA

profile Monthly Salary: $ 270000 - 305000
Posted on: 18 hours ago
Vacancies: 1 Vacancy

Job Summary

Description

We are a fast-growing and dynamic organization seeking aMedical Director / Sr Medical Directorto join our Clinical Development team. The Medical Director / Sr Medical Director will play a key role at all stages of clinical development. The successful candidate will have oversight for planning and execution of clinical trials and be involved in the exploration of novel indications. The role will provide clinical leadership to cross-functional project teams on development strategies clinical study outlines and protocols. Compilation and interpretation of study results and interfacing with multiple cross-functional areas including clinical operations safety medical and scientific communications commercial (marketing sales managed markets) regulatory product manufacturing and supply will be key responsibilities as well as communication and interpretation with external partners clinical investigators and Key Opinion Leaders.

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Who is Omeros

Omeros is an innovative biotechnology company that discovers develops and commercializes first-in-class small-molecule and protein therapeutics for large-market and orphan indications with particular emphasis on complement-mediated diseases cancers and addictive or compulsive disorders. Omeros lead lectin pathway inhibitor YARTEMLEA which inhibits the pathways effector enzyme MASP-2 is FDA-approved for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients ages two years and older with a inJanuary 2026. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review by theEuropean Medicines Agency with a decision expected in mid-2026. OMS1029 Omeros long-acting MASP-2 inhibitor has successfully completed Phase 1 clinical trials.

Under a recently announced asset purchase and licensing agreementNovo Nordiskacquired global rights to zaltenibart (formerly OMS906) a MASP-3 inhibitor in clinical development for PNH and other alternative pathway indications along with associated intellectual property and related assets. Omeros pipeline also includes OMS527 a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder and fully funded by theNational Institute on Drug Abuse as well as a growing portfolio of novel molecular and cellular oncology programs. For more information about Omeros and its programs visit.

What are your job responsibilities

  • Develop strategic plans for clinical indications of products development candidates
  • Participate in cross-functional teams to develop and implement integrated clinical scientific and commercial strategies for Omeros products
  • Serves on cross-functional teams as the Clinical Lead and disease state expert to develop the clinical development strategy
  • Responsible for translating clinical development strategy into clinical trial outlines and protocols
  • Provides ongoing medical monitoring for clinical trials including assessment of eligibility criteria toxicity management and drug safety surveillance
  • Work closely with clinical investigators and their staff globally
  • Will be part of a team preparing and reviewing regulatory documents IND annual reports IND safety reports investigator brochures and development plans
  • Will be part of a team responsible for defending the clinical development program before regulatory authorities
  • Work closely with external KOLs on exploration of novel indications development plans and study outlines
  • Helps to ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
  • Provides Clinical Leadership in the collection analysis and interpretation of clinical data for internal review
  • Will help to develop abstracts for scientific congresses and manuscripts for publication in peer-reviewed journals
  • Serves as a scientific and clinical resource within Omeros Clinical Research
  • Provides scientific and clinical guidance to Biology Toxicology Clinical Trials Management Biometrics Global Drug Safety Regulatory and Project Management staff
  • Assists in the clinical evaluation of business development opportunities
  • Functions as the scientific/medical reviewer for PRC and MRC as required

What education and experience do you need

  • An MD is required specialization and clinical experience in hematology is desired
  • A scientific background and significant biotechnology/pharmaceutical industry experience is required
  • Attention to detail
  • Excellent verbal and written communication skills to a range of internal and external audiences
  • Effective problem solving and systems thinking skills
  • Effective conflict resolution skills
  • Demonstrated leadership skills
  • Strong interpersonal skills

Behavioral Competencies Required:

  • Ability to successfully work in a fast-paced ever changing environment
  • Demonstrated ability to work well with management peers and subordinates fostering an effective team spirit
  • Ability to successfully work individually within a multi-disciplinary team as well as with external partners and vendors
  • The ability to analyze negotiate and manage/measure work
  • The proven ability to effectively collaborate and influence decision-making across multiple levels of an organization including senior leadership
  • Integrity and credibility
  • Strategic thinking and prioritizing capacity
  • Innovation and creativity

Other Requirements:

  • This role will require 10 20% travel (medical conferences etc.)

Supervisory Responsibilities:

  • Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws
  • Responsibilities include interviewing hiring and training employees; planning assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems

Compensation and Benefits:

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for Medical Director / Sr Medical Director position is(Med Dir $270000-$305000 Sr Med Dir $325000-$375000). Salaries will be determined based on knowledge skills education and experience relevant to the role. Employees are offered medical dental vision life insurance and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for incentive and stock options. To learn more about Omeros please visit.

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@ or contact Omeros asking for Human Resources at .




Required Experience:

Director

DescriptionWe are a fast-growing and dynamic organization seeking aMedical Director / Sr Medical Directorto join our Clinical Development team. The Medical Director / Sr Medical Director will play a key role at all stages of clinical development. The successful candidate will have oversight for plan...
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Key Skills

  • EMR Systems
  • Post Residency Experience
  • Occupational Health Experience
  • Clinical Research
  • Managed Care
  • Primary Care Experience
  • Medical Management
  • Utilization Management
  • Clinical Development
  • Clinical Trials
  • Leadership Experience
  • Medicare