Director, Clinical Leader (Established Products)

Johnson & Johnson, is recruiting for a Director, Clinical Leader (Established Products) to be located in the US (Titusville, NJ; Raritan, NJ; or Horsham, PA), Switzerland or Belgium. Other locations in EMEA and APAC may also be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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 EP Clinical Leader reports to the EP Compound Development Team Leader (CDTL) and is accountable for deliverables on assigned products and projects within the portfolio with high scientific quality and within agreed upon timelines and budgets. The Clinical Leader is a critical member of the Compound Development Team (CDT) which is dedicated to maximizing the value of the asset to patients and the company through the execution of all phases of clinical development and provides active medical and scientific contribution to cross-functional clinical teams to support the successful completion of clinical projects and deliverables that enable registrations for new indications, enhancements to the label, and compliance with regulatory commitments for marketed products.

Responsibilities:

• The Clinical Leader acts in concert with senior clinical personnel, as a company spokesperson regarding publication of clinical research findings and presentations to relevant Health Authorities (HAs), such as FDA and EMA, advisory committees, and review meetings.
• Executing clinical studies for new formulations, pediatric exclusivity, post-approval commitments, and new indications. The Clinical Leader leads teams in preparing development plans, protocols, Clinical Study Reports (CSRs), and documents for regulatory filings. The Clinical Leader is responsible for medical monitoring and safety reporting of clinical studies.
• Leading Clinical Teams in the fulfillment of Phase IV commitments and other projects as required by HAs.
• Providing active medical and managerial leadership for the operational implementation and execution of clinical programs through matrix management of cross-functional teams. Medical and scientific problems are discussed and solved within teams.
• The Clinical Leader is a core member of the CDTs, a leader of the Clinical Team, and a member of the Global Labeling Teams (GLTs) and Safety Management Teams (SMTs).
• The Clinical Leader acts as a liaison between company and investigators and develops collaborative relationships with key opinion leaders.
• Working with cross-functional teams, such as Regulatory Affairs and Global Medical Safety, to update the Company Core Data Sheets (CCDS), Summary of Product Characteristic (SmPCs), United States Prescribing Information (USPIs), and other local labels for products in the portfolio.
• Collaborating with international teams on responses to requests from HAs and timely implementations of corrective actions as needed.
• Participating in cross-functional teams for evaluation of new product ideas, reviews medical literature, and related new technologies.

Qualifications

Minimum Qualification

• MD or equivalent required.
• At least 5 years of pharmaceutical industry experience in clinical research and development required.
• At least 10 years of clinical and development experience required.
• Background in Internal medicine through Infectious Diseases therapeutic area is preferred.
• Previous academically based research experience is desired.
• Energy and enthusiasm are essential.
• Outstanding oral and written communication skills are essential.
• Outstanding and proven leadership success is required.
• Ability to work effectively in a matrix team environment is a strong plus.
• Candidate should possess strong and proactive problem-solving skills for developing creative solutions and meeting project objectives.
• Candidate should have demonstrated ability of strategic thinking and contingency planning with respect to portfolio objectives.
• A global mindset and ability to collaborate and partner cross-culturally/regionally is required.
• Up to 15-25% yearly travel may be required (international and domestic)

The anticipated base pay range for this position is $186,000 to $322,000.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

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.