Director, Program Management (CMC)

Location
94080, South San Francisco
Posted
Aug 10, 2018
Discipline
Science/R&D, Chemistry
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

DIRECTOR, PROGRAM MANAGEMENT (CMC)

Position Summary:

The Director, Program Management (PM) will be a member of the cross-functional Chemistry, Manufacturing and Controls (CMC) teams for two programs, including one NDA stage program and one early stage program. The PM will partner with all functions on the CMC team (chemical development, formulation development, analytical development, manufacturing, supply chain, quality assurance, regulatory affairs) as well as the technical team leader for each of the CMC teams in the development and implementation of CMC project strategies and comprehensive project plans.

Essential Duties and Responsibilities:
 

  • Facilitate cross-functional CMC project team meetings, both internally and with partners/CMOs, and document and communicate key takeaways to relevant constituents
  • Identify critical topics that should be brought to other team members/meetings. Ensure the project information is appropriately communicated, keep clarity and transparency within the CMC team
  • Monitor project progress and identify risks and opportunities to timeline, budget or scope
  • Follow-up on action items with the functional representatives
  • Maintain overall CMC timelines and milestones from drug substance to finished product, monitor status, identify risks and develop mitigations
  • Build fully integrated project schedules (Gantt chart) capturing all manufacturing activities and resources needed to deliver against corporate goals in partnership with CMC leads and functional representatives
  • Assist CMC leadership with management of the CMC budget by monitoring actuals to plan and forecasting
  • Support CMC planning for regulatory filings, and create tracker to track status of CMC-related modules
  • Partner with team leaders in interactions with corporate governance bodies to ensure programs have adequate budget and resources to support approved scope

Qualifications:

  • MS or PhD degree preferred with a minimum of 10 years of relevant experience
  • Experience within a CMC function including hands on experience in early to late phase drug substance and drug product development
  • Understanding of ICH guidelines, and industry best practices
  • Knowledge CMC for small molecules, NDA and launch experience
  • 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
  • Some US and international travel required (less than 20%)
  • 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 race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.