Clinical & Regulatory Program Manager

Location
San Diego, CA
Salary
Base plus Bonus plus Options - Limited Relo Available!
Posted
Mar 21, 2018
Required Education
Bachelors Degree
Position Type
Full time

It's an exciting time to join Arena, with multiple, potential “best in class” drugs. In addition, the project management team is expanding further and is looking to bring on a clinical PM to join the ralinepag team.

The Clinical & Regulatory Program Manager (CRPM) is responsible for program management support to clinical development and regulatory affairs to include acting as the lead PM for the development and commercialization of assigned product/workstream. The CRPM ensures projects are designed according to project scope, milestones and key deliverable dates; executed, tracked and prioritized according to guidance from program team; remain within scope and budget; and delivered on time. The clinical program manager will also facilitate clinical/regulatory team meetings associated with the project as well as develop/manage the budget. Finally, the manager is a key team member and subject-matter-expert (SME) for program management’s processes, procedures, protocols and general best practices.

What you'll dive into

  • Applies project management expertise, methodologies and department standards to assist in building a world-class program management function (e.g., PMBOK)
  • Communicates effectively with team members and key stakeholders on assigned program’s progress, issues, risks, needs and opportunities
  • Communicates regularly with team members, key stakeholders and the broader organization on assigned program’s progress and status; Escalates critical issues and delays to leadership with a plan-of-action to address
  • Creates, modifies and actively supports the short- and long-term PM clinical/regulatory strategies tied to assigned product
  • Develops and drives continuous improvements; tracks KPI’s and metrics; and implements best practices in support of the advancement of a broad portfolio of drug candidates
  • Develops, maintains, tracks and manages a high quality, integrated clinical/regulatory project plan, including clearly identified critical paths and key risks as needed
  • Facilitates and coordinates delivery of clinical/regulatory documents
  • Supports the clinical development leader and sub-teams in the development and refinement of the clinical development strategy
  • Supports the global regulatory leader in the delivery of key regulatory submissions to health authorities
  • Participates in development and improvement of key business processes, tools and templates related to program management, best practices, and cross-functional pharmaceutical product development
  • Supports Financial Planning & Analysis in developing, maintaining, tracking and managing the clinical budget and by identifying budgetary impacts of strategic and critical issues
  • Tracks progress against all targets, and produces timely and accurate status update reports to the leadership/PM teams via a standardized dashboard

What we expect

  • Bachelor’s degree in relevant field required; Advanced Degree (e.g., MBA, MS, PhD) is preferred
  • PMP or similar certification highly preferred
  • 5+ years of relevant and progressive experience
  • 3+ years of program/project management experience required
  • 2+ year of direct clinical operations and/or clinical project/program management
  • Significant experience in full-cycle drug development/pharma required; Experience participating in the commercialization of therapeutics is highly desirable
  • Advanced experience using Microsoft Office Suite including Project, Excel, Power Point and SharePoint required; Experience with SmartSheet is helpful
  • Ability and passion to work in demanding, dynamic, fluid and fast-paced environment
  • Advanced understanding of program management and associated deliverables, tools and expectations; PMBOK SME
  • Clear understanding of the critical path and a drive to find solutions to meet or exceed timelines
  • Demonstrated ability to act/think strategically and see “the big picture”, all the while being hands on
  • Demonstrated ability to organize multiple priorities and projects
  • Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines
  • Demonstrated knowledge and hands-on experience in the clinical operations/study management process, including Good Clinical Practices (GCP)
  • Demonstrates excellent communication (verbal/written/presentation) skills
  • Detail-oriented with effective problem-solving and troubleshooting skills
  • Process oriented with the ability to understand complex data and information
  • Travel up to 5% (US and International)

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives

  • Opportunities to learn and contribute creative solutions

  • Comprehensive health insurance ($0 premium on select medical plans)

  • Matching 401k retirement plan

  • Paid time off and holidays including a Summer & Winter break

  • Company celebrations

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays including a Summer & Winter break
  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.