Director, Clinical Program Management

Location
Seattle
Posted
Jan 22, 2021
Ref
1730
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Sr. Clinical Program Manager/Associate Director, Clinical Program Management

The Sr. Clinical Program Manager (CPM)/Associate Director, Clinical Program Management is responsible for leading and directing the execution of clinical studies for an assigned clinical program and developing and supporting the clinical strategy to align with Omeros' mission. The role will work closely with Clinical Trial Managers, CRO, and vendors to ensure the execution of studies in assigned clinical program in compliance with quality standards (including but not limited to ICH, GCP, local regulations, and Omeros' SOPs) on schedule and on budget. The role will play a key role in starting up assigned clinical studies to meet study milestones and company goals.

Good things are happening at Omeros!

Come join our Omeros Clinical Team!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

  • Lead clinical study start-up activities with minimal oversight
  • Plans and manages the overall execution of the assigned clinical program to meet necessary quality, budget and timelines
    • Develop plans, manage budgets and timelines ensuring productive relationships with internal and external customers while leading and managing the decision-making and risk management process, troubleshooting and proactively dealing with vendor/ collaborator issues
  • Responsible for program budget planning and accountable for external spend related to program execution
    • Works closely with Clinical Trial Managers, Product Project Management and Finance to ensure on a regular basis that budgets, enrollment and timelines are accurate
    • Communicates program status, cost and issues to ensure timely decision-making by senior management
  • Provides oversight of the CRO and the vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to the CRO and vendor for assigned program, including escalation of issues to senior management
    • Vendor qualification, performance evaluation, and problem resolution
    • Responsible for operational risk management strategy in collaboration with the Associate VP, Clinical Operations
    • Provides program-level direction to Clinical Trial Managers for the development of study management plans including enrollment, risk management, communication, and monitoring, in collaboration with the CRO, to ensure inspection readiness
  • Reviews and provides expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures (IB), Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), Investigational Medicinal Product Dossier (IMPDs), study synopses and protocols, Clinical Study Reports (CSRs), New Drug Applications, Biological License Applications (BLAs) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents
  • Performs other delegated tasks including clinical operations and clinical trial process improvement plan development
  • Supports clinical team as a whole, team management efforts, implements team goals, and is responsible for performance reviews and employee development
Associate Director, Clinical Program Manager will have the following responsibilities in addition to listed above:
  • SOP and working instruction development, review, modification, tracking, and study support. Performs gap analysis of SOP and working instructions to develop risk management plan
  • Makes or recommends operational strategies and/or decisions (with input from Associate VP, Clinical Operations) in support of achieving clinical program objectives
  • Provides clinical operations strategies to Product Development Team meeting as a clinial operation program lead
  • Responsible for managing direct reports, Clinical Program Manager and/or Clinical Trial Manager
What education and experience do you need?

  • A BA/BS degree with a related degree in a Life Science; an MS degree is highly desirable
  • A minimum of 8+ years of relevant progressive project/program management experience in the pharmaceutical industry and/or a clinical research organization, including 4+ years clinical study management; experience must include Phase 2 and 3 studies and global/international studies or programs
  • The Associate Director, Clinical Program Management must have at least 1 year of experience in one or more clinical product development program(s) as a Clinical Program Manager or quivalent experience
  • Knowledge of FDA regulations/ICH/ GCP guidelines
  • Proficiency in MS office including Word, Excel, PowerPoint, and other applications
  • Excellent written, verbal, and interpersonal communication skills
  • Strong analytical and problem-solving skills; detail orientation
  • Actively promotes constructive interactions among team members in order to address difficult situations
  • Resolves and negotiates conflicts or problems with tact, diplomacy and composure
  • Demonstrated ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
Behavioral Competencies:

  • Demonstrated ability to interact, build and maintain positive relationships with all levels including management, peers, and subordinates as well as vendors
  • Ability to establish and maintain credibility with professionals on the project teams
  • Demonstrated ability to understand, motivate others and build effective teams
  • Demonstrated ability to develop and present varied and unique ideas
Supervisory Responsibilities:

  • This position may have supervisory responsibilities
  • Responsibilities may include interviewing, hiring and training employees; planning, assigning, and directing work, and appraising performance
  • This position may also supervise work in a matrix organization
Physical Demands Required:

  • May encounter prolonged periods of sitting
  • The employee may frequently be performing repetitive movements such as typing on a keypad or using a mouse
  • The employee may climb bend, reach, push, pull, balance, stoop, kneel, or crouch
  • The employee must on occasion lift and/or move up to 20 pounds
Other Requirements:

  • Requires approximately 10-20 % travel, including overnight and international travel
If you have the experience, skills and knowledge we are seeking, we'd love to hear from you! This is an exciting opportunity for the right person!

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