Johnson & Johnson is currently seeking a Senior Director, Scientific Affairs for Aesthetics and Reconstruction to join our team located in Irvine, CA.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

• Provides strategic direction to members of the medical affairs department.
• Oversees large and complex clinical trials and provides support on design, execution, and reporting of clinical trials, ensuring consistency across program studies.
• Provides guidance on the most complex inquiries from/to data management, study operation team, or investigators.
• Provides counsel on the largest and most complex product research projects in preparation for health authority submissions.
• Advises on organizational standards regarding external stakeholder management, scientific communications, evidence generation, publications, and medical education activities.
• Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs.
• Acts as a senior company representative interacting with external scientific leaders, medical decision makers, professional societies, patient organization and/or regulatory authorities as appropriate
  Responsible for development and in-year implementation of the global medical plans supporting global medical strategy in collaboration with cross-functional partners.
• Establishes appropriate strategic partnerships with centers of excellence, societies, regulators and health care professionals in areas of scientific interest.
• Collaborates with GSR & GSM to develop and lead global clinical KOL engagement plan.
• Collaborates with Legal, Compliance and Regulatory to ensure proper and ethical interactions between Medical Affairs staff and external stakeholders.
• Contribute to Medical Affairs Strategy by providing deep medical/ clinical expertise.
• Oversee Planning, designing, and managing global medical Advisory Boards as appropriate.
• Oversee medical review and approval of Investigator Initiated Research (IIS) proposals and other grants through the grant approval process.

• Master's Degree with a minimum of 15 years of experience OR a PhD or PharmD with a minimum of 10 years of experience is required.
• An MD is preferred.
• A minimum of 7 years of people management-related experience is required (including management of direct reports).
  Class III Medical Device experience is highly preferred
• Expertise in clinical research design 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 is required.
• Ability to lead a team of clinical scientists to provide strategic and scientific clinical research input across NPD and LCM projects.
• Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance with SOPs and regulations.
• Comprehensive understanding of clinical trial regulations across multiple regions.
• Ability to collaborate across different functional areas within Clinical Research and Medical Affairs to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives.
• Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders.
• The ability to influence, shape and lead without direct reporting authority.
• Change agent in team progression.
• Proven track record of excellent budget management working closely with finance partners.
• Excellent written and oral English communication skills across a variety of platforms.
• Ability to travel domestically and internationally up to 50%.