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Senior Director, Clinical Development
Company: Johnson & Johnson
Location: La Jolla, CA
Employment Type: Full Time
Date Posted: 09/25/2021
Expire Date: 12/22/2021
Job Categories: Biotechnology and Pharmaceutical, Government and Policy, Healthcare, Other, Healthcare, Practitioner and Technician, Human Resources, Information Technology, Sales, Science, Research & Development, Medical, Nonprofit and Volunteer Services, Entrepreneurship
Job Description
Senior Director, Clinical Development

Senior Director, Clinical Development

Company Overview

Janssen is a pharmaceutical company of Johnson & Johnson, working to prevent, treat, and cure complex diseases while changing the way diseases are managed, interpreted, and prevented. Janssen operates in over 150 countries around the world, aiming to innovate and empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

Janssen aspires to transform lives by bringing life-saving and life-changing solutions to people who need them. They are committed to providing safe and effective medicines as well as the services and support that contribute to healthy outcomes. This calls for the best science, the most creative minds and an openness to collaborate with researchers, governments and patient organizations at every stage – from early discovery to market access and patient education.

Janssen offers products in the following therapeutic areas: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Janssen Research & Development Innovation

At Janssen, a key goal is developing and implementing new approaches to make the clinical trial process better and faster for all stakeholders: patients, trial sites/investigators and the healthcare industry at large.

Janssen Research & Development Operations Innovation is a specialized global team leading these efforts, in partnership with drug development teams across Janssen. They work to identify, develop and test new operational models, technologies and solutions for clinical research, as well as to support Janssen’s vision of “A World Without Disease.

Their team works to facilitate broad implementation of successful solutions throughout the Janssen organization. Janssen is committed to open innovation, looking beyond their own walls for inspiration and sharing solutions they have developed with the industry.

In carrying out their mission to transform clinical trials, Janssen collaborates with leading healthcare organizations, technology partners and pharmaceutical companies. They also provide leadership to industry organizations that share a similar vision for clinical trial innovation. Janssen also partners with governments and non-profits on new access, pricing, education, and support strategies. This kind of collaboration comes naturally to Janssen – given their decentralized organizational structure and open, entrepreneurial culture.

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.

The role is responsible and accountable for the oversight of the Scientific and Clinical Development strategy across indications for assigned Compound Development Team (CDT) asset(s) at Janssen.  This position is a Core member of the Compound Development Team (CDT) and in collaboration with key CDT functions, including Translational Medicine, Late Phase Clinical Development, GCSO, and other key functions, the DLAD is responsible for the strategy and delivery of clinical programs across the Alzheimer’s Disease space as well as the Tau strategy,  accountable for developing the overall clinical development strategy for assigned programs, including oversight of the design, implementation and reporting of programs in targeted disease states.  The successful candidate will have exceptional clinical development, direct and indirect-leadership and communications skills as well as a high degree of curiosity, innovation, entrepreneurship and a keen sense of patient unmet need. Responsibilities will include: membership on the Compound Development Teams, Membership on the Safety Management Team and other product oversight teams, accountability for clinical program reviews in the broader Janssen R&D structure, and overall strategy and execution of clinical development programs through product licensing.  This role may also have substantial responsibility for defining Development approaches for licensing/Business Development activities.

Senior Director, Clinical Development Primary Responsibilities

  • Collaborates with Disease Area Strongholds (DASs), as well as Core and Extended CDT functions that may include Translational Science and Medicine, Late Clinical Development, Discovery, Clinical Pharmacology, Medical Affairs and Commercial, and Business Development to develop and oversee delivery of a comprehensive clinical development strategy.
  • Leads a team of physicians and scientists who design, implement and report early and late-stage clinical trials in disease targets delivering to the compound/product strategy.
  • Advises AD teams on innovative study designs based on the latest lessons learned in AD research (trial design, utilization of biomarkers, statistical methods, etc.)
  • Promotes consistent best practices for trial implementation across various existing and new drug candidate programs
  • Provides input on recruitment and development of junior early and late phase AD/ medical personnel to build a team of experts
  • Mentors/coaches junior medical personnel, imparting experience to develop a strong, industry leading AD medical team
  • Maintains strong relationships within the AD research field further strengthening the "Janssen AD Brand" and enabling successful research collaborations
  • Collaborates with external experts to provide in-depth biomedical expertise and strategic guidance to compound development teams and all levels of management
  • Expands external scientific visibility and reputation of Janssen by driving publications and participating in scientific seminars and discussion forums
  • Assumes accountability for oversight and strategic direction of clinical portions of regulatory submissions, including licensing applications and other regulatory submissions.
  • Delivers innovative, fit-for-purpose and transformational development strategies that address high unmet need for the CDT asset(s) in the AD space.  This includes next-generation combination regimens to achieve transformative levels of efficacy.

General Leadership Expectations

  • Strong capacity to work in a matrixed environment, leading directly and indirectly
  • Ability to lead through delegation and work collaboratively across diverse teams
  • Outstanding visionary, strategic, communication and entrepreneurial skills
  • Develop and maintain a strong external network including credible relationships with scientific leaders, key clinical opinion leaders, and regulatory officials as needed to advance the AD/Neurodegeneration portfolio
  • Develop and maintain strong internal network with cross-functional groups required to operationalize and drive portfolio progression
  • Exceptional communication skills and leadership experience in clinical development to communicate goals and deliverables to senior management and governance committees through J&J


Professional Experience and Requirements

  • MD/DO required
  • Completed postgraduate training in neurology or psychiatry required
  • At least 10 years of AD clinical development experience within pharma or equivalent roles required
  • Clinical development and scientific experience in Tau-related pathologies and conditions  highly desirable
  • At least 5 years of general pharma experience (including a strong fund of knowledge in safety, regulatory, statistical, operational and other drug development functions) required
  • Expert knowledge of and experience in AD clinical care and research, including late phase required
  • In depth knowledge of the clinical progression of AD and patient, caregiver and HCP journeys to use to guide commercial and medical teams required
  • Expert knowledge of and experience in biomarkers used for subject phenotyping and monitoring of disease progression in AD required
  • Expert knowledge of and experience with clinical scales most commonly used in AD research required
  • Good presentation skills
  • Fluent in English (written and spoken) required 

This position may be remotely located and may require approximately 25% travel, both international and domestic. The successful applicant must be willing to travel to New Jersey, La Jolla and Belgium as required.

For additional information please visit http://www.janssen.com/

Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
North America-United States-California-La Jolla, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)
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