Associate Director, Clinical Development - Gastroenterology - Spring House Pennsylvania

Company: Disability Solutions
Location: Spring House, Pennsylvania
Posted On: 04/21/2024

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/. Johnson and Johnson is recruiting for an Associate Director, Clinical Development - Gastroenterology , to be located in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company. As Immunology Leaders, we know immunology is vital to human health. Driven by a relentless focus on patient unmet needs, we will redefine treatments for immune diseases by delivering transformational and accessible therapies and regimens to patients with immune-mediated disease. For more than two decades we have been a world leader in the development of transformational medicines, establishing one of the strongest, first-in-class portfolios and pipelines in the industry, including the first tumor necrosis factor (TNF) inhibitor, and first interleukin (IL)-12 and IL-23 inhibitors. We tirelessly push the boundaries of science and creativity, applying our deep disease insights, novel pathway science, new technologies, and treatment modalities to restore immune homeostasis. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. POSITION OVERVIEW The Associate Director, Clinical Development is part of the Development Physician team at Janssen Immunology, with clinical development and medical/scientific responsibility for Phase 2 and 3 programs, and providing applicable disease area expertise (including Gastroenterology for the Therapeutic Area [TA]). The Associate Director, Clinical Development is a key 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, Global Medical Safety, Regulatory Affairs, Quality, Medical Affairs, Commercial and Market Access. Beyond individual internal drug development programs, the Associate Director, Clinical Development also contributes to innovation initiatives in disease/pathway areas, drug development processes, and external partnering/business development. The position will support clinical development strategy, and clinical trial protocol design, development, and execution. The position will also have a leadership role in the conduct of clinical trials, investigator meetings, regulatory interactions, and study and submission document writing. The successful candidate will have strong communications skills, relevant clinical and matrix workplace experience, and a high degree of curiosity, flexibility, innovation, entrepreneurship, and drive to address unmet medical needs for patients. RESPONSIBILITIES: --- Medical/scientific responsibility for Phase 2 and 3 clinical trials/programs, including: o Design: concepts, project plans, protocols, case report forms, operational and analytic plans o Execution: regulatory/Ethics Committee applications, start-up, enrollment, medical monitoring, database 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 responsibility for compound-level right-to-operate elements, including Investigator Brochures, Safety Update Reports, Risk Management Plans, and product labelling --- Medical/scientific responsibility in interactions with internal cross-functional partners and senior leaders, external medical/scientific investigators/experts/leaders, and 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 and combinations, precision medicine/patient stratification o Novel outcome measures for inclusion in clinical trials/practice/labelling --- Medical/scientific responsibility 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 EXPECTATIONS The successful candidate will have a passion to drive programs into diverse immune-mediated inflammatory disease indications, based on scientific rationale and unmet medical needs. General expectations --- Strong passion to drive programs into diverse indications, based on scientific rationale and unmet medical needs --- Strong potential to work, collaborate, communicate, and influence in a cross-functional matrix environment, delivering Immunology TA strategies with a one-team, one-portfolio mindset --- Foundational understanding of clinical research / drug development, with strong potential 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 More...

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