The Senior Director, Head of Immunology Translational Science and Medicine (TSM), Clinical Science Lead will provide strong leadership to the Clinical Science group within TSM and lead changes to transform early clinical development in Immunology. They will be a key partner with Global Development (GD), the Immunology Clinical Excellence and Transformation team and Clinical Pharmacology to build and implement an effective operating model for early clinical studies. The TM Clinical Science Lead will drive clinical and operational trial excellence in accelerating the time from NME declaration to FIH, from protocol concept to study start, and from study start to decisional top line results.

The TM Clinical Science group is comprised of expert clinical scientists who lead the clinical study protocol concept, design, and execution from FIH through Ph IIa (PoC) clinical studies. The Clinical Science Lead will be responsible for reviewing trial documents and will serve as the main interface with the GD organization for clinical execution oversight. They will collaborate with and advise Translational Medicine Projects Leaders (physician/scientists) in the generation of early clinical development plans. The successful candidate will collaborate with a talented group of TSM and Late Development leaders to ensure excellence in design, execution, and impact of translational studies.

TSM is an integrated group of scientists that includes a Translational Science group and a Translational Medicine group which collectively drives the design, conduct and interpretation of early clinical development and experimental medicine studies. The Clinical Science Lead will be a line manager for all Clinical Scientists, some of whom have line management responsibilities themselves. This responsibility includes training and mentoring clinical scientist leads who are accountable for developing clinical trial protocols and collaborating with translational medicine program leads and global trial leads in operational execution of Ph1 through PoC trials. In this position the senior director will be accountable for providing an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force, in ensuring that each report is supported in career and talent development goals.

In this leadership role the Clinical Lead will be supported by other senior leaders within the Translational Science and Medicine function, including the relevant disease area leaders (both in clinical development and biomarker science). Within TM, the Senior Director will be a core member of the TSM Leadership Team with responsibility for creating and implementing TSM organization initiatives.

This position will report to the VP of Translational Science and Medicine.

Johnson & Johnson Immunology has a history of bringing life-changing therapies to patients with immune-mediated diseases. The mission of TSM is to develop the next wave of novel therapies for these patients. We are looking for an outstanding candidate with strong matrix leadership skills, a depth of industry experience in early development and a proven ability to lead change to join TSM and help us bring these new therapies closer to patients.

Essential functions:

Deliver the early portfolio within Therapeutic Area budget and time commitments with the collective ambition of best in industry trial performance.

Lead change to develop and implement a fit for purpose operating model for Immunology early clinical development.

Manage a large and growing group of Clinical Scientists ranging in level from Scientist to Director. The Clinical Science Lead will directly manage ~3-4 Directors; overall the group of clinical scientists will be approximately 15-20.

Core member of Immunology Protocol Review and Operating Committee review teams.

Core member of Translational Science and Medicine Leadership team.

Build productive relationships with key partners outside of the TA (including Global Development and Clinical Pharmacology and Pharmacometrics) and within the Immunology TA, particularly with Late Development and the Clinical Excellence group.

Provide senior review of trial-related documentation.

Qualifications

• MD or MD/PhD degree required.
• A strong record of matrix leadership experience and managing people and larger teams (minimum 5+, 10+ preferred) is required.
• 10+ years of industry experience in clinical development is preferred with a minimum of 3 years' experience in early clinical development is required.
• Experience with different types of early studies (including healthy volunteer dose escalation, clinical pharmacology and patient studies and proof of concept) is strongly preferred.
• Experience in immunology clinical development is preferred with experience with innovative trial designs (e.g., adaptive, platform, bucket) also preferred.
• Experience with small molecules, biologics and other platforms strongly preferred.

The anticipated base pay range for this position is 193000 to 333500. California Bay Area - The anticipated base pay range for this position is $238,000.00 to $382,950,00.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• 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)).
• This position is eligible to participate in the Company's long-term incentive program.
• 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 of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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.

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.