Senior Director, Clinical Affairs

Description:

Johnson & Johnson is currently seeking a Senior Director, Clinical Affairs to join our team located remotely within the United States.

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.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

The Senior Director of Clinical Affairs will play a key leadership role as the company continues to transform the treatment of poorly served patient populations with paradigm changing technologies. The role will be responsible for a portfolio of complex clinical studies and requires a high level of autonomy and impact. This Senior Director of Clinical Affairs role will specifically be responsible for oversight of the clinical program for Shockwave’s coronary sinus reducer. The candidate will work with physician advisors and other external stakeholders including regulatory bodies. The individual will be responsible for building and maintaining a high-functional clinical team and for the oversight of external research partners. Significant hands-on oversight of complex clinical studies and implementation work is required in this role.

The Senior Director of Clinical Affairs will come with a background in creating and executing clinical strategy and influencing internal stakeholders within the product development team to drive business results. The candidate should have experience with cardiovascular medical devices and cross-functional product development core teams including risk management and clinical strategy. This candidate is accountable for clinical study management activities, for providing work direction to in-house clinical staff, and for successful completion of clinical milestones in compliance with applicable regulatory and business standards. The candidate is responsible for coordination with cross-functional counterparts and contract research organizations (CROs) across global studies in conformance with applicable regulatory requirements to meet business objectives. The Senior Director of Clinical Affairs will establish processes and best practices, in addition to maximizing metrics and reporting on clinical activities. Significant interactions with physician investigators and study staff are required on the use of Shockwave Medical products during the clinical investigation to ensure the clinical data reported are complete, accurate and true.

This position requires critical thinking skills with respect to program strategy and clinical operations execution to evaluate the safety and effectiveness of new and existing products. This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and has significant impact to the business.

Essential Job Functions

• Design and execute global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management activities.
• Partner with cross-functional partners in product development to meet business objectives.
• Obtain in-depth knowledge of clinical issues that may impact clinical and business objectives.
• Develop and execute clinical strategies.
• Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Lead internal clinical research teams to ensure milestones are met. Coach and mentor the team to maximize performance.
• Oversee the performance of CROs and external research partners to ensure study integrity and business milestones are met.
• Oversee administrative activities associated with the clinical department including development and maintenance of clinical procedures, hiring and training of key personnel, and preparation and maintenance of objectives and budgets.
• Oversee study start-up including clinical contracts, CROs, data management activities and clinical study teams to meet business priorities.
• Oversee a team of field clinical engineers providing case support for clinical procedures.
• Manage study enrollment by ensuring appropriate enrollment strategies are in place to meet milestones.
• Ensure data integrity during conduct of study, oversee clinical data analysis, clinical study reports and participate in evidence dissemination.
• Other duties as assigned.
  
  

Qualifications:

• Minimum Bachelor’s Degree in a scientific field of study.
• Minimum 15 years’ experience directly supporting clinical research including 5+ years of managerial experience.
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
• A history of effective collaboration with regulatory agencies through clinical studies and market releases.
• Strong knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
• Excellent prioritization and organizational skills.
• High attention to detail and accuracy.
• Finance and budgeting knowledge.
• Excellent critical thinking influencing and negotiation skills.
• Works effectively on cross-functional teams.
• Effective written, verbal and presentation skills with all levels of management and organizations.
• Operate both as a team and independently, with adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.
• Ability to travel 30-40% domestically and internationally as needed.
  
  

The anticipated base pay range for this position is 193000 to 333500. California Bay Area - The anticipated base pay range for this position is 238000 to 382950.