small11

 

Senior Director, Life-Cycle Leader at Achaogen
South San Francisco, CA, US
Position Summary:

This role will serve as the Life-Cycle Leader for Plazomicin, Achaogen’s lead product candidate being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). Plazomicin has been evaluated in two Phase 3 clinical trials: the EPIC registration trial and the CARE descriptive trial. Both trials reported top-line data in December 2016, and NDA submission is anticipated in 2017.



Reporting to the VP of Project and Portfolio Management, the Senior Director, Life-Cycle Leader (LCL) will have overall accountability for the planning, execution and delivery of late stage projects/products. The LCL is accountable for an aligned product vision, strategy and all related activities for late-stage portfolio projects, including Phase II and III clinical and CMC development, regulatory submission and approval, and commercial planning, launch and ongoing life-cycle management.



Essential Functions:

Oversee all aspects of development, commercialization and manufacturing of assigned late stage development and/or marketed product(s).
Provide strategic leadership to the Life-Cycle Team (LCT), a multifunctional team comprising of preclinical and clinical development, technical operations, regulatory, medical affairs and marketing activities.
Develop a product vision, and lead the LCT in the preparation of Product Life-Cycle Plan as an integrated development, manufacturing and commercial plan.
Provide recommendations to Executive Committee to maximize the value of late stage products, within scope of the LCT and context of the broader portfolio, over the entire lifecycle of the product.
Mobilize the organization's implementation of the Product Life-Cycle Plan, including collaboration with commercial, development and technical operations sub-team leads to ensure alignment of development and marketing plans with the target product profile.
Ensure development, management and reporting of project financials, including annual budgeting of all development related investment.
Ensure proper staffing of the product’s LCT and key sub-teams.
Ensure strategic and tactical plans and timelines are developed, approved and implemented cross-functionally and globally.
Ensure proper expert peer review of plans throughout the organization.
Drive relevant partnering and licensing activities in relation to projects/products.


Skills and Experience:

10+ years progressive pharmaceutical development related business experience, the majority of which in leadership capacity.
Extensive experience with developing and executing product life-cycle plan strategies and tactics.
Knowledge and/or experience with US and/or global product sales and market planning; Global product launch experience strongly preferred.
Proven experience leading and motivating matrix teams (10+ employees) on complex programs/projects with aggressive milestones.
Proven experience as a successful decisive leader in a strategic, multifunctional environment.
Experience influencing senior management with regards to product strategy, technical data and resources.
Experience leading or operating within a product development (Clinical & CMC) environment.
Knowledge and/or experience with complex, regulated medical devices a plus.
Market-relevant experience of infectious disease and/or anti-infective a plus.


Preferred Education:

Minimum of BS/BA in Business or Life Sciences.
Graduate degree (Science or MBA) and / or equivalent experience and education in strategic leadership and business preferred.


Preferred Additional Skills:

Strong leadership, communication, presentation and business partnering skills.
Strong analytical skills with proven ability to think strategically.
Strong interpersonal skills and ability to work with others in a positive, collaborative manner.
Strong ability to work well on cross-functional basis internally and with business partners.
Able to effectively handle multiple tasks and priorities in a fast-paced environment.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Current US work authorization required.
Ability to travel domestically and international.