Senior Manager, Program Management - Clinical Development

Location
San Francisco, CA, United States
Posted
Oct 18, 2019
Ref
706
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR MANAGER, PROGRAM MANAGEMENT - CLINICAL DEVELOPMENT

Position Summary:

This position will report into the Dir, Program Management and will be responsible for providing Clinical Project Management expertise and operational support, enabling the success of the cross-functional voxelotor study execution teams (SETs) and other tactical sub-teams of the Clinical Sub-Team (CST) as appropriate.

As the SETs are accountable to the CST, a major component of this role is supporting the CST PM lead by aligning with the program strategy and ensuring information flow between the CST and the SETs, providing strategic context, scope of requests, as well as coordination and support for all cross-functional deliverables (i.e. cross-functional recommendations, slide decks) ensuring timing of deliverables align with the overall program objectives. Partnering with the SET lead, this PM will map, coordinate and track all critical activities, including study project plans (timelines) and supporting on-time achievement of SET key milestones and tasks.

As support for CST sub-teams, this individual will work with function heads in the identification of resources to support the sub-teams (IB, DSUR, CSR, regulatory submissions, protocol and amendment working groups), provide a framework for the deliverable (strategic context to drive timeline planning and execution), developing the project timeline, calendaring meetings, driving agendas, capturing and disseminating meeting minutes including action items and their follow-up through resolution, ensuring the schedule timelines are met with high quality and on time.

This individual will ensure escalation of issues which impact the agreed upon clinical development plan, regarding timelines, budget or risk, and guide the SET through the corporate process as needed. This individual may share CST support with the CST PM lead on as add needed basis.

Essential Duties and Responsibilities:
  • Supporting the SET in maintaining focus and alignment with the overall program priorities as defined by the CST (in partnership with the SET Lead)
  • Identification of issues, gaps and risks, working with the team to develop mitigation planning, and escalating to the CST for agreement and guidance; guides teams on the corporate process
  • Drives information flow and communicates project status to all stakeholders in collaboration with the CSTL, SET lead, and/or sub-team lead as appropriate, via oral and written communications
  • Facilitates team building and communication; proactively identifies and resolves team challenges
  • Develops cross-functional project timelines (Gantt chart) identifying all significant activities and dependencies. Continually shares timeline with members to ensure Project is on track or to adjust plans and communicate to appropriate stakeholders.
  • Identify members of any new sub-teams as needed (i.e. protocol amendment working group, IB, DSUR, submissions), develops, distributes and drives agendas, identify tasks and accountable persons, set up and facilitate effective meetings, captures and disseminates meeting minutes, captures and drives appropriate follow up on action items, and ensures appropriate escalation
  • Supports project status updates in monthly dashboard
  • Creates and maintains easily accessible, high level project documents in electronic format
  • Prepares information with appropriate input from team members for internal as well as external partner review/governance meetings
  • Develops knowledge of current therapeutic environment and drug development trends as needed
  • Leads/supports program management functional initiatives and supports cross-functional initiatives as needed

Qualifications:
  • BS, MA, MPH, MBA degree with a minimum of 5 years of relevant experience
  • Experience within a cross-functional development program including leadership positions in early to late phase product development
  • Understanding of ICH guidelines, and industry best practices
  • Experience in leading from a PM perspective key, mid-stage deliverables (IB, CSR, protocols, amendments)
  • Proven project management skills
  • Excellent ability to embrace ambiguity and complexity and demonstrate problem-solving leadership with limited oversight; ability to translate complex concepts into actionable, measurable tasks
  • Demonstrated ability to influence outcomes and key project decisions without authority
  • Demonstrated ability to manage and lead others through change
  • Strong knowledge of team dynamics, structure, roles and responsibilities
  • Ability to respond quickly and effectively to changing environments
  • Strong organizational skills and attention to detail
  • Ability to work both independently and in a team focused environment
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Comfortable executing on multiple projects independently

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.