Executive Assistant To Svp Global Quality

Vor 4 Tagen

Basel, Basel-Stadt, Schweiz Viking Vollzeit

Job Description - Vice President, Head of Development Neurodegeneration (2506237570W)

Johnson & Johnson is recruiting for a Vice President, Head of Neurodegeneration Development to be based at one of our sites in Titusville, NJ; Cambridge, MA; Spring House, PA; La Jolla, CA; Alschwil, CH; or Beerse, BE.

The Development Head (DH) is responsible for all late development activities within the Neurodegeneration Disease Area (ND) - which includes neuroinflammation - and reports to the Global Head of Development for Neuroscience. In this role, the DH provides global leadership and direction to clinical research staff within ND and directly manages late phase compound development team leaders (CDTLs) and physicians. The DH assigns or provides needed clinical support and consultation for projects related to their discipline outside of the TA, across J&J and for other Janssen R&D companies. Working with his or her functional partners, the DH plays a key role in the development and execution of the Therapeutic Area and Disease Area strategies.

RESPONSIBILITIES :

  • Core member of the Disease Area Leadership Team (DALT) and the Neuroscience Development Leadership Team.
  • The DH has responsibility for the ND development strategy in alignment with Disease Area Strategies, and for assuring an integrated, efficient, effective and timely implementation of that strategy.
  • The DH ensures that CDTs develop thoughtful, integrated asset development strategies and appropriately capture these in the Asset Development Plan document. Helping teams identify and address the key issues, alternative strategies considered, and key stages of development (with associated GO / NO GO decision points and criteria).
  • The DH, working with the CDTL, assures that the issues and concerns of the functional partners are addressed so that the clinical strategy and the implementation of that strategy is comprehensive, effective, and highly integrated.
  • The DH has ultimate responsibility and accountability within ND for protocol design and for final protocols, clinical study reports, and regulatory packages / submissions. He or she may delegate some of these responsibilities, as appropriate.
  • The DH represents the clinical development group to the rest of the franchise, including at SLT meetings, and to the units of JRD and other Janssen R&D companies.
  • The DH is responsible for decisions regarding external presentation of clinical research data, including timing and appropriateness of content. In this role, the DH will work with the CDTL and with functional partners from global medical affairs, health care compliance, legal regulatory, and other relevant groups.
  • The DH is responsible for final approval of each compound's risk language, working closely with the Clinical Leader, the CDTL, and the Global Medical Safety (GMS) group representative.
  • The DH is responsible for assuring appropriate clinical input and direction for programs, and is expected to provide review and input, from the clinical development perspective, for all programs going for DALT and SLT approval.
  • The DH is accountable for providing leadership to the clinical research staff within ND, assuring the high quality of work produced, and that the staff is provided timely, detailed, and constructive feedback, and that the staff is progressing in their professional development.
  • The DH has financial accountability for the teams for which he / she is responsible. The DH is accountable for business plans (BPs) and executing according to the business plans.
  • The DH is responsible for building and maintaining a top quality clinical research unit, staffed with industry-leading clinical research staff, capable of designing and conducting effective and efficient clinical development programs.

Qualifications :

  • MD or equivalent, MD / PhD a plus.
  • At least 15 years of professional experience with a minimum of 10 years in pharmaceutical R&D.
  • Experience of phase late phase study design, execution and interpretation including regulatory filings.
  • Experience of a leadership role in a multifunctional R&D organization.
  • Needs to be a strategic thinker.
  • Experience in a leadership role within a global multi-functional R&D matrix organization; strong track record of producing results in a matrix-based environment.
  • Strong oral and written communication skills.
  • Fluent in written and spoken English.
  • Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.

The anticipated base pay range for this position is $253,000 to $465,750 USD.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

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