Prothena

Program Team Leader - PRX003

US-CA-South San Francisco
Job ID
2017-1172
Category
Research & Development

Overview

The Program Team Leader (PTL) is responsible for leading a cross-functional matrix team to bring a candidate compound (PRX003) in Prothena’s portfolio through registration, commercialization, and life-cycle management.  The PTL leads the Program Team (PT) in the creation and management of the Target Product Profile and the development and execution of a cross-functional compound development strategy throughout the lifecycle of the asset.  The PTL is the champion of the product at all levels across the Prothena organization and is responsible for the cross-functional integration of asset related functional strategies and execution plans. The PTL is also responsible for communicating progress against the development plans and for obtaining guidance and approval of program parameters from Prothena’s Leadership team and other governance bodies, as appropriate.

 

This position reports to the Vice President Portfolio Management.

 

About PRX003
PRX003 is an investigational monoclonal antibody that targets CD146, also known as melanoma cell adhesion molecule (MCAM), for the potential treatment of inflammatory diseases, such as psoriasis and psoriatic arthritis.

CD146 is a cell adhesion molecule expressed on the surface of Th17 cells which are an underlying cause of several inflammatory diseases. CD146 functions like hook-and-loop fasteners, allowing Th17 cells to adhere to the blood vessel wall and migrate into tissues to initiate the inflammatory process.

PRX003 is designed to occupy CD146, leading to downregulation which sequesters pro-inflammatory Th17 cells in the bloodstream and prevents their migration into tissue. PRX003 may also induce the demargination of Th17 cells that are already adherent to blood vessels and/or tissue.

Prothena announced its strategy to advance a Phase 2 clinical study of PRX003 in patients with psoriatic arthritis based on certain pre-specified criteria being met in an ongoing Phase 1b proof-of biology study in patients with psoriasis.

Responsibilities

  • Lead the PT in the generation of a Target Product Profile and the cross-functional compound development strategy, lifecycle strategy, and operational plans (Compound Development Plan, CDP), in alignment with functional strategies and plans for development, registration and commercialization through the end of exclusivity.
  • Lead the PT in execution of the CDP; refine the CDP as needed based on evolving information.
  • Partner with Project Management and Finance to assess required resources and budget. Oversee the program budget in the matrix organization.
  • Adhere to health authority regulations, company ethics and SOPs; Makes procedural recommendations, as needed.
  • Partner with functional area representatives on the PT, with the Portfolio Management Team, and with line function leads to optimize the success of the compound throughout its lifecycle
  • Build team effectiveness, ensuring cross functional partnerships and resources are leveraged effectively and with accountability to achieve development goals; drive collaboration and transparency across all functions on the PT; challenge team members to continuously think strategically and deliver based on high quality tactical execution.
  • Help PT members reach optimal performance and provide performance feedback to functional heads.
  • Represent the product to appropriate Prothena governance bodies and the Leadership Team (LT); Document and communicate validated, version controlled information (‘single version of truth’) regarding milestones, development plans and achievements to LT and governance teams. Identify and escalate issues as appropriate and guide contingency planning with solutions focused mindset.
  • Collaborate with regulatory for the preparation of health authority meetings, submission strategy, review of documents and participation in Health Authority meetings, as needed.
  • Develop relationships with external organizations/experts in support of clinical and medical activities in alignment with CDP.
  • Collaborates with Medical Affairs and other team members to develop comprehensive publication strategy to support the compound.

Qualifications

Education and/or Experience:

  • Graduate degree with post-graduate training in a discipline related to drug development
  • 10-15 years of leadership experience in the biotechnology and/or pharmaceutical industry setting
  • Strong knowledge of the end-to-end drug development process and of preclinical, clinical, CMC, regulatory, pre-commercial and commercial requirements of drug development programs
  • Previous experience with the development and successful registration of an experimental therapeutic
  • Expert cross functional collaboration and leadership skills, including active development and maintenance of a close working relationship with functional, leadership, and governance team members to assure a closely coordinated program of activities based on common objectives
  • Skilled at influencing decision making; ensure functional team discussions/activities lead to resolution and are in alignment with the strategy
  • Working knowledge of ICH guidelines, relevant regulatory guidance, and GLP, GMP and GCP procedures
  • Ability to lead senior leaders and to effectively delegate responsibility and authority while navigating functional and cross-functional responsibilities in the matrix structure
  • Good project management skills; ability to track and influence multiple activities lead by various functional subteams to ensure deliverable of key milestones
  • Experience in developing budget and resource plans for development programs

Preferred:

  • Experience with the successful leadership of a compound development team through registration, commercialization and life cycle management
  • Previous work with cell adhesion pathologies and / or development programs in Psoriatic Arthritis is preferred
  • Successful track record in planning, conducting and publishing of discovery and/or clinical science

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, creativity, selflessness and humor
  • Acts with a sense of urgency; retains an ability to act with grace and resilience under pressure
  • Good communication (written and verbal) and presentation skills
  • Strong time management, interpersonal and organizational skills

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