Johnson & Johnson is hiring for a Sr. Director, Office of Medical Affairs to be located in Santa Clara, 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. 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.

• Objectives and deliverables of direct reports including mentorship and employee development.
• Create and maintain OMA operating procedures that support regulatory and practice guidelines.
• Participate in the Clinical and Medical Affairs leadership team and ensure alignment within the team.
• Provide scientific insight into corporate objectives, evidence dissemination, and the value of SWMI products in the treatment of calcified cardiovascular disease.
• Responsible for the creation, execution and communication of the clinical evidence dissemination plan.
• Interpretation of clinical data to assess the safe and effective use of SWMI medical devices.
• Create scientific presentations for physicians and business partners and oversee medical writing of manuscripts for evidence dissemination.
• Support the complaint reporting process in collaboration with the CMO and Quality department.
• Understand imaging based modalities for assessment of device performance following lithotripsy-enhanced therapy including angiograms, IVUS, and OCT studies.
• Develop and propose future data collection needs to further support/validate science and clinical outcomes.
• Make recommendations to optimize lithotripsy procedure based on clinical results.
• Conduct review of clinical cases for root cause analysis of individual outcomes.
• Partner with cross-functions including R&D on product performance.
• Participate in the authorship and review of clinical study documents for Clinical Affairs.
• Educate the field sales force and internal partners on relevant clinical data results.
• Oversee the ISR program, complete scientific review of ISR proposals, manage the ISR committee, and provide timely feedback to physicians.
• Respond to unsolicited scientific requests, linking Shockwave Medical scientific data to real life physician practice to meet customer needs.
• Manage key opinion leaders; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Other duties as assigned.

• Minimum Bachelor's Degree in a scientific field of study. Advance degree strongly preferred (PhD, MD, PharmD, etc.).
• Minimum 12 years' experience directly supporting clinical research or relevant experience in medical/scientific area.
• Strong leadership skills coupled with excellent management history with a minimum of 5 years' experience managing others.
• Medical device industry experience in cardiovascular medicine.
• Strong knowledge of FDA and international regulations and guidelines including, but not limited to clinical investigations, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, unapproved use, and ADVAMED Code.
• Knowledge of International Committee of Medical Journal Editors (ICMJE) guidelines.
• Ability to develop and maintain key opinion leader relationships.
• Effective performance on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such.
• Effective written, verbal and presentation skills across various audiences.
• Operate as a team or independently while maintaining flexibility and resilience.
• Ability to travel up to 40% of the time both domestically and internationally
• Statistical analysis methodology and tools.
• High attention to detail and accuracy, good prioritization and organizational skills.
• Excellent critical thinking skills.
• Excellent influencing and negotiation skills.
• High energy and results-oriented individual who is successful in a business environment and is skilled in motivating and inspiring people.
• Entrepreneurial "hands-on" experience. Pro-active and "can do" attitude.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Employee may be required to lift objects up to 25lbs.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year