POSITION OVERVIEW

The Director, Clinical Development is part of the Development Physician team at Johnson and Johnson Innovative Medicines - Immunology, providing clinical development and medical / scientific leadership for Phase 2 and 3 programs, and applicable disease area expertise [including Dermatology/Immunology] for the Therapeutic Area (TA).

The Director, Clinical Development is a leading member of cross-functional teams focused on the creation and execution of integrated clinical development plans which seek to produce transformational and accessible therapies for patients with immune-mediated inflammatory disease. The role involves close partnership with project clinical scientists and extensive collaboration with colleagues across disciplines, including discovery, translational science & medicine, clinical pharmacology, biostatistics, data science, medical writing, clinical operations, medical safety, regulatory affairs, quality, medical affairs, commercial and market access. Beyond individual internal drug development programs, the Director, Clinical Development also contributes to innovation initiatives in disease / pathway areas, drug development processes, and external partnering / business development.

The successful candidate will have strong clinical development, matrix leadership, and communications skills, with a high degree of curiosity, flexibility, innovation, entrepreneurship, and drive to address unmet medical needs for patients.

Primary Responsibilities

• Medical / scientific leadership of Phase 2 and 3 clinical trials / programs, including:

o Design: concepts, project plans, protocols, case report forms, operational & analytic plans

o Execution: regulatory / ethics committee applications, start-up, enrolment, medical monitoring, lock, close-out activities

o Analysis: interpretation of clinical and scientific data

o Reporting: internal communications, external scientific disclosure, regulatory filings (including marketing applications and associated activities)

• Medical / scientific leadership for compound-level right-to-operate elements, including Investigator Brochures, Safety Update Reports, Risk Management Plans, & product labelling

• Medical / scientific leadership in interactions with internal cross-functional partners and senior leaders, external medical / scientific investigators / experts / leaders, & health authorities

• In collaboration with Compound Development and Disease / Pathway Area Stronghold teams, development / execution of:

o Disease / pathway area strategies including indication / target prioritization, future treatment paradigms incorporating treatment sequences & combinations, precision medicine / patient stratification

o Novel outcome measures for inclusion in clinical trials / practice / labelling

• Medical / scientific leadership in business development activities, including assessment / due diligence for external program / asset partnering opportunities

• Participate in cross-departmental / cross-functional projects with broad Janssen impact

General Expectations

• Strong passion to drive programs into diverse indications, based on scientific rationale and unmet medical needs

• Strong capacity to work, collaborate, communicate, influence, and lead in a cross-functional matrix environment, delivering Immunology TA strategies with a one-team, one-portfolio mindset

• Broad understanding of clinical research / drug development with ability to drive innovation and maintain high standards of research conduct

• Develop and maintain an external network including credible relationships with scientific leaders, key clinical opinion leaders, and regulatory officials as needed to advance the Immunology portfolio

• Represent Janssen Immunology in a highly professional manner internally and externally

Qualifications

Professional Experience and Requirements

• MD, MD/PhD

• Significant (at least 8 years) experience in clinical care / research for complex diseases. In particular:

• Industry experience in clinical development is preferred.

• Strong track record of producing results in a matrix-based environment

• Approximately 10-20% annual travel may be required (domestic and international)

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.

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