Medical Director / Sr. Medical Director, Clinical Development at Omeros

Seattle, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

20 May, 26

Salary

375000.0

Posted On

19 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Development, Clinical Trials, Protocol Development, Medical Monitoring, Safety Surveillance, Regulatory Documents, KOL Interaction, Good Clinical Practice, Data Interpretation, Scientific Communication, Leadership, Problem Solving, Conflict Resolution, Strategic Planning, Cross-functional Teamwork, Business Development Evaluation

Industry

Description

We are a fast-growing and dynamic organization seeking a Medical Director / Sr Medical Director to 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. Good things are happening at Omeros! Come join our Marketing Team! 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 pathway’s 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 planned U.S. launch in January 2026. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review by the European 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 agreement, Novo Nordisk acquired 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 the National 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 www.omeros.com. 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 organization’s 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 $270,000-$305,000, Sr Med Dir $325,000-$375,000). 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 www.omeros.com. 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.

Responsibilities

This role involves providing clinical leadership for cross-functional teams, overseeing the planning and execution of clinical trials, and exploring novel indications for development candidates. Key duties include compiling and interpreting study results while interfacing with various internal departments and external partners like investigators and Key Opinion Leaders.