Senior Counsel, Clinical Affairs
The Senior Counsel, Clinical Affairs will provide primary legal support for clinical development and clinical operations activities of the Company related to pipeline products and will contribute to the efficient and effective delivery of legal services throughout the organization as a collaborative member of a dynamic legal team.
Good things are happening at Omeros!
Come join our Omeros Legal Team!
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 ~~~
What are your job responsibilities?
- Provides legal advice related to the management of US and global clinical contracting strategies for all US and global clinical trial activities in collaboration with internal cross-functional stakeholders, external collaborative vendors and legal department colleagues.
- Serves as primary legal representative in clinical study team meetings.
- Provides day-to-day legal advice regarding US and global clinical development and clinical operations activities and programs of the Company related to pipeline products with a primary focus on the laws, rules, regulations applicable to clinical development, including but not limited to FDA and EMA regulations, Good Clinical Practice (GCP), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use (ICH) guidelines, data protection and privacy regulations, insurance protections, and other requirements applicable to the biopharmaceutical industry; coordinates to obtain and integrates advice of outside legal counsel on relevant matters within areas of responsibility.
- Leads and conducts the drafting, review, negotiation, and management of clinical trial agreements, local representation agreements, informed consent documents, and other documents required for legal, ethical and compliant conduct of clinical trials by a biopharmaceutical industry sponsor.
- Review and negotiate vendor contracts, including clinical research organization agreements, master services agreements, and confidential disclosure agreements related to clinical development and clinical operations activities.
- Builds constructive working relationships with internal clients and external collaborators.
- Collaborates with colleagues and vendors to advance knowledge management initiatives within the legal department.
- Develops a thorough understanding of and familiarity with the company's business, its people, products, markets, facilities, customers and competitors and utilizes that knowledge in providing guidance and counsel to internal clients.
- Identifies and communicates to risks associated with day-to-day operational business activities and contributes to the efficient and effective delivery of legal services to cross-functional colleagues processes, including by training clients on applicable legal issues within lawyer's expertise and developing or refining relevant playbooks and procedures.
- Undertakes other duties and responsibilities, as assigned, to provide legal support for other attorneys, projects or functional areas of the business.
Education, Skills and Knowledge:
- Juris doctorate (JD Degree)
- Licensed to practice law in at least one U.S. state, with admission in Washington State preferred.
- A minimum of seven (7) years of relevant substantive experience representing life sciences companies in a law firm, biopharmaceutical company, contract research organization or a combination thereof.
- Strong understanding of the conduct of clinical trials and legal challenges that impact clinical trial operations in the biopharmaceutical industry.
- Knowledge of contract, clinical, FDA, and drug laws and regulations specific to the biopharmaceutical industry
- Skilled in drafting and negotiating clinical trial agreements, informed consents, CRO agreements and other documents relevant to global clinical trial operations.
- Ability to analyze, interpret, and apply government regulations, guidelines, and requirements
- Ability to identify problems and work to implement solutions.
- Ability to exercise good judgment regarding the interpretation of policies, development of procedures, and selection of appropriate courses of action.
- Self-starter with strong drive for results and strong sense of ownership, but also willing to take direction.
- Superior communication and interpersonal skills.
- Ability to work in a team environment and assist others, as needed.
- Must have excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Behavioral Competencies Required:
- The ability to work well with management and peers and to function as an effective part of a team that has an entrepreneurial spirit
- The ability to analyze risk and legal issues, negotiate, and manage/measure work
- High integrity
Physical Demands Required:
- Intermittent physical activity including bending, reaching and/or pushing, pulling, or lifting up to 40 lbs.
- May encounter prolonged periods of sitting
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 ~~~ or contact Omeros, asking for Human Resources, at ~~~