Johnson & Johnson Careers

Sr. Director Clinical Sciences

Santa Ana, California
Clinical Research non-MD


Job Description

Requisition ID: 7818180724

Johnson & Johnson  Vision is recruiting for a Senior Director, Clinical Sciences to be located in Santa Ana, CA. 
 
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
 
Responsibilities
  • Operating on behalf of Johnson & Johnson Vision, this role is accountable to lead the Clinical Sciences R&D organization, supporting the global portfolio, partnering with our Platform Leaders, Clinical Operations team, other R&D colleagues, Supply Chain, Quality and other key stakeholders.
  • Provide deep clinical and scientific insight that accelerates innovation, value and safety for patients and customers everywhere through strong leadership and partnership with the following innovation and business partners:  R&D, Global Strategic Marketing, New Business Development, External Innovation, Regulatory, Quality and Supply Chain.  
  • Shape the industry by building strong relationships externally with key customers and stakeholders (Key Opinion Leaders, Surgeons, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care to deliver quality products/solutions.  
 
The Senior Director of Clinical Sciences is responsible/ accountable for:


Innovation/ Evidence Generation:  
  • Provides Clinical input into Target Product Profile and Development Plans.
  • Drives global innovation agenda across JJ Vision through strategic accountability, alignment, and leadership with the following innovation leaders and business partners:  Medical Affairs, Global Strategic Marketing, New Business Development, R&D, Regulatory, Medical/ Clinical Affairs, Quality and Supply Chain, leveraging deep expertise. 
  • Ensures team is successful in establishing long-term product opportunities, as well as unmet medical needs, designing inputs and evidence needs for development programs and post market products. 
  • Ensures team is successful in proactively shaping strategic evidence generation strategies in partnership and alignment with Medical Affairs, Preclinical, Regulatory, Quality and other stakeholders.  Develop and execute global integrated strategies for evidence generation for new and existing products in order to support innovation, regulatory approval/clearance, health technology assessment, customer access, medical safety and post-marketing support.
 Clinical Science:
  •  Responsible for delivery of assigned programs, through effective partnership with the Clinical Operations, to enable optimized engagement leading to the delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP).
  • Ensure input and strong alignment from key Clinical & Medical leads and other strategically important countries/regions in the development programs.
  • Lead and ensure appropriate support of clinical scientific discussions with regulatory authorities.
  • Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc.
  • Foster strong relationships with external stakeholders to shape and influence relevant policies, etc.
  • Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement.
 Functional and Technical Competencies:
  • Broad Medical Device/technology, scientific expertise 
  • Connected Partnerships- Leverages relationships w/key portfolio constituents to deliver tangible results and clinical insights
  • Pipeline Delivery - Successful Product Development and Launch delivery
  • Expertise in clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
  • Ability to lead a team of technical experts to provide strategic and scientific clinical input across NPD and LCM projects
  • Proven track record in delivering clinical programs within clinical/surgical research settings, on time, within budget and in compliance to SOPs and regulations
  • Comprehensive understanding of clinical trial regulations across multiple regions. 
  • Integrated evidence generation approaches
  • Scientific/technical communications including dissemination.
Leadership Competencies:
Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, and Deliver as noted below. 
  • Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS/EDS
  • Shape – build strong relationships with external stakeholders to shape and influence relevant policies
  • Lead – develop talent to provide strategic and clinical capability, including responsibility for professional development of direct reports
  • Deliver – ensure programs are delivered on time, within budget and in compliance to regulations and SOPs
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
  • Performs other related duties as required.

Qualifications
  • Advanced Degree required (for example; MD, OD and/ or PhD).
  • Minimum of 10 years of related experience is required.
  • Industry experience leading Clinical/R&D teams in a highly regulated, commercial medical device business is required. 
  • A minimum of 8 years related scientific/technical experience, including leadership/management role.
  • A minimum of 5 years people management-related experience is required for this role.
  • Demonstrated expertise and success in building Clinical Research or Research & Development teams and leaders to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas.
  • Familiarity and experience with FDA standards and processes for product launches is preferred.
  • Must possess high emotional intelligence; possess excellent oral and written communication skills; possess excellent interpersonal skills for interactions with internal colleagues and external customers.
  • Effectively manage in a matrix environment and demonstrate influence capabilities.
  • Demonstrated effective Change Leadership and Change Management skills to lead organization through transformation.

Primary Location
United States-California-Santa Ana
Organization
AMO US Holdings, Inc.. (6234)
Job Function
Clinical Research non-MD
Requisition ID
7818180724