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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.

We are searching for the best talent for the Senior Director, Medical Affairs to be based in Irvine, CA.

The Senior Director, Medical Affairs develops and drives the top-level decision-making of the development and implementation of the respective global medical affairs strategic and tactical plans.

Responsible for the MSL organization and Field Research Specialists. Drives KOL/PI/site level engagement plans.

Leads the development and execution of advisory boards, scientific and medical education programs. Provides scientific/medical education to all relevant internal stakeholders related to therapeutic area or disease specific information.

Formulates evidence plans and organization activities based on project life cycles and stakeholder and client feedback.

Supports strategic development and execution of publication plans and scientific communications for all clinical programs.

Responsible for Medical Information Request process, copy approval, and provides support and development on field-based educational and promotional materials for scientific accuracy.

Provides medical affairs expertise and support to product development teams and medical affairs teams, including training to other staff internally across functions.

Partners with commercial and clinical development to support product strategy based on external and internal input.

Establishes academic cooperation and maintains communication channels with medical experts in relevant disease areas.

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.

Proactively creates a purpose driven environment by aligning Johnson & Johnsons Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.

Qualifications:

• A minimum of a Doctorate degree (e.g., PhD, MD, DVM, or equivalent degree) in biosciences, medicine, bioengineering, or a related field is required.
• A minimum of 10 years’ experience managing a senior scientific staff (Phd. DVM, MD) is required.
• A minimum of 10 years’ experience in a medical device industry is highly preferred.
• SME in electrophysiology and/or cardiology preferred
• Extensive knowledge of requirements for regulatory submissions for FDA and international agencies, like TUV and EU MDR, with proven track record of successful approvals of submissions to FDA and other international agencies is required.
• Deep knowledge of AdvaMed Code and proven track record of leading compliance across the Medical Affairs Organization is required.
• Ability to partner collaboratively with various functions in a challenging and changing environment is required.
• Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement, and support the transformation of a function is required.
• This position will be based in Irvine, CA and will require up to 35% domestic and international travel.

Additional Key Traits for Success:

• Must possess high emotional intelligence; excellent oral and written communication skills; excellent interpersonal skills for interactions with internal colleagues and external customers.
• Ability to lead, inspire and influence a team, functioning in a matrixed structure, through a period of change and in alignment with the strategic direction of the Scientific Affairs leadership team.
• Self-reflective and aware of her/his own limitations, open to feedback and self-improvement.
• Demonstrated business acumen to understand implications of preclinical decisions
• A proven ability to execute and get results through leading others in complex technical organizations whilst leading by example.
• Demonstrated ability to build successful relationships and develop partnerships with key business partners and customers/investigators.
• A risk-taker who anticipates and mitigates risks or unintended circumstances.

The anticipated base pay range for this position is 196,000 - 338,100.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through innovative programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love! At Johnson & Johnson, we offer a variety of outstanding health and financial benefits, including competitive compensation, 401k, pension, medical, dental, and vision insurance, exercise reimbursement, flexible time off, paid volunteer and parental leave, and more!

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

EU Regulations, FDA Regulations, Medical Device Regulations, Regulatory Approvals, Regulatory Submissions

 

 

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Process Optimization, Product Strategies, Stakeholder Analysis, Strategic Thinking