Medical Director/ Sr. Medical Director, Clinical Development

 

Position Summary:

Reporting to the CMO, the Medical Director/Senior Medical Director, Clinical Development will play a key role at all stages of clinical development programs from the drug discovery stage through product registrations world-wide. The successful candidate’s primary responsibilities will be oversight for planning and execution of clinical trials and will be involved in the exploration of novel indications. The role will provide medical expertise and clinical leadership to cross functional project teams on development strategies, clinical study outlines and protocols, and data interpretation of study results. The Medical Director will interface with multiple cross-functional areas including clinical operations, medical and scientific communications, commercial (marketing, sales, managed markets), regulatory, and safety, product manufacturing and supply, as well as external partners, clinical investigators and Key Opinion Leaders.

 

Who is Omeros? 

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.

 

Good things are happening at Omeros!

  

Come join our Clinical Team!

 

Essential Duties & Responsibilities: 

• Develop strategic plans for clinical indications of product development candidates
• Participate in cross-functional teams to develop and implement integrated clinical, scientific, and commercial strategies for Omeros products
• Serve 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
• Provide 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 a 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
• Help to ensure adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
• Provide Clinical Leadership in the collection, analysis, and interpretation of clinical data for internal review
• Help to develop abstracts for scientific congresses and manuscripts for publication in peer-reviewed journals
• Serve as a scientific and clinical resource within Omeros Clinical Research
• Provide scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff
•  Assist in the clinical evaluation of business development opportunities
• Function as the scientific/medical reviewer for PRC and MRC, as required

 

Education, Experience, Skills, and Knowledge Required:

• An MD is required, specialization and clinical experience in hematology or nephrology is desired 
• A scientific background and 3 or more years of  biotechnology/pharmaceutical clinical development industry experience is required
• 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 (solutions oriented, coaching, counseling, etc.)
• Attention to detail
• 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

 

Travel 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

 

Physical Demands Required:

• Intermittent physical activity including bending, reaching and/or pushing, pulling, or lifting up to 20 lbs.  
• May encounter prolonged periods of sitting 

 

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 the Medical Director/Sr. Medical Director, Clinical Development is $270,000 - $330,000. 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 bonus and stock options. To learn more about Omeros, please visit www.omeros.com. 

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

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.