Prothena

VP, Clinical Development

US-CA-South San Francisco
Job ID
2017-1180
Category
Research & Development

Overview

The Vice President of Clinical Development will report directly to the Chief Medical Officer and will be responsible for implementing and directing the clinical strategy of the development programs.  The successful candidate will possess a solid understanding of US and international regulations and the drug approval process. A clear understanding of translational medicine is required, including but not limited to, basic pharmacokinetics/pharmacodynamics principles, the use of biomarkers, and data interpretation as they apply to drug development.  This role will manage the design and execution of clinical studies, oversight and interpretation of clinical trial data and clinical interactions with cross-functional groups across the organization.  This role will represent Prothena in external interactions with regulatory authorities, scientific and academic collaborators, patient advocacy organizations, and other external stakeholders.  This role will also be the clinical lead responsible for successful completion of the phase 2b/3 studies, registration, and global launch of Prothena’s lead compound NEOD001.

 

Responsibilities

  • Fully accountable to lead and oversee the clinical development team in the design and execution of all clinical studies across the full clinical (D1, X2 and X3) and preclinical (X4, other) portfolio
  • Formulate the clinical development plan, ensure integration of clinical plan and strategy with the needs of other stake holders (e.g., Regulatory Affairs, Medical Affairs, Commercial, etc.)
  • Provide clinical and scientific input during development, execution and completion of clinical trials
  • Reviews safety and efficacy data, leads the study team through analysis and interpretation of the study results, and makes recommendations as to appropriate next steps
  • Partner closely with other functional areas within R&D (pharmacology, preclinical, translational medicine, statistics, safety, etc.) and external investigators and consultants (KOL, scientific advisory board) and vendors to facilitate the execution of clinical trials and programs
  • Interpret clinical trial data and prepare reports, regulatory submissions and publications based on the results
  • Identify, interact and build collaborative relationships with key opinion leaders and academic organizations to assure incorporation of latest methods and guidelines into clinical development plans
  • Oversee clinical advisory board meetings to obtain strategic input into clinical program development
  • Prepare and present study status and strategy to management and the board, and prepare for global regulatory submissions, inspections and publications
  • Build a team of clinical scientists and oversight clinical development and regulatory interactions across the pipeline
  • Engage and inspire the teams through communication of strategic plans and vision

Candidate Profile

Prothena is seeking an experienced and dynamic clinical development leader. The ideal candidate will have a strong medical orientation with business sense and pragmatism as well as high scientific and ethical integrity. S/he should have proven leadership skills including managing, developing and mentoring direct reports with the ability to inspire confidence, motivate and align a scientific team behind common goals. The successful candidate will have a track record and demonstrated success of advancing programs form proof-of-concept through late stage development. S/he will have an entrepreneurial bent and action orientation that fits with a growth oriented company.

 

S/he should demonstrate superior analytical and organizational skills with the ability to manage multiple projects effectively and simplify large amounts of complex information to draw valid conclusions. The successful candidate should have excellent communication skills with the ability to collaborate and influence colleagues across all levels of the organization.

The ideal candidate will be bright, eager, and have a strong results orientation with a demonstrated track record of success. This leader will be comfortable executing in uncertain environments and acting with a sense of urgency, however, will retain grace and resilience under pressure. Personal qualities of high integrity, strong ethics, collaborative nature and good interpersonal skills are required. Ultimately, they must demonstrate leadership to drive results that are needed to achieve company objectives in accordance with Prothena’s culture and core values – courageousness, creativity, selflessness and humor.

Qualifications

Education and/or Experience:

 

  • MD required with 10+ years of pharmaceutical development or other relevant experience required
  • Thorough knowledge of GCP and ICH guidelines associate with clinical research and regulatory submissions (NDAs and/or BLAs, INDs), and other regulatory documents (CSRs, IB and clinical study protocols) required
  • Demonstrated ability to manage teams and success in working with and influencing key external stakeholders (i.e. KOLs, investigators) including presenting and responding to FDA and other regulatory authorities
  • Solid understanding and experience with US and International regulatory authorities and the drug approval process
  • Experience in rare diseases is desirable, but not required
  • Travel – approximate 15%

 

In terms of the performance and personal competencies required for the position, we would highlight the following:

Setting Strategy

  • A creative strategic thinker, with ability to develop and oversee clinical development strategy, taking into account scientific, clinical, regulatory, and commercial considerations.
  • Demonstrated strategic and analytical skills to integrating diverse disciplines. Ability to consider new information outside of his/her area of expertise. Thinks creatively and integrates appropriately recommendations and experiences of others.
  • Ability to lead strategically and make decisions effectively based on available information. Inspires others to consider different perspectives.

Executing for Results

  • Results-oriented; establishes clear expectations and priorities, drives key initiatives to completion, sets goals, and consistently delivers against the plan. Innate desire and proven ability to have an impact.
  • A hands-on leader who monitors progress and proactively addresses issues and obstacles with a flexible and creative approach to problem solving.
  • Energetic self-starter with a strong sense of urgency. Able to set direction and execute despite incomplete information.

Leading Teams

  • Demonstrated ability to lead, inspire and motivate a highly skilled and talented team of scientific professionals.

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