Johnson & Johnson companies are equal opportunity employers.
Sr. Director, Clinical Development, Psychiatry-6623130904
Description
Janssen Pharmaceuticals, Inc. a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Director, Clinical Development, Psychiatry for the CNS Medical Affairs group, to be located in Titusville, NJ.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Director is responsible for directing the design, conduct and reporting of clinical trials and related activities within the US medical affairs Psychiatry therapeutic area supporting the interests of Janssen Pharmaceuticals, CNS Medical Affairs. Responsibilities include overseeing clinical personnel and frequent interactions with internal and external business partners including regulatory, brand marketing, JRD, PGSM, HECOR, epidemiology, investigators/KOLs in the areas of clinical psychiatric practice, payers and pharmacists. The Senior Director must have the expertise to develop a strategic plan, defend it through J&J management review and direct/create/maintain the processes/interactions necessary to establish and direct this function in accordance with regulatory, corporate and industry standards in addition to effectively managing other Medical Affairs professionals. People leadership responsibilities are a central part of the responsibilities as well as advancing the scientific strategy, goals and objectives CNS Medical Affairs. Reports to the Therapeutic Area Leader, Psychiatry.
Essential responsibilities include: Manage several Associate Directors or Directors of Clinical Development, for guiding work, giving feedback, assessing and conducting performance and potential conversations; Provide scientific expertise, oversight and direction as required for the design, conduct and analysis of clinical trials and commercialization of company products. Specific activities include study design, protocol development, fulfilling the role of medical monitor and ensuring study conduct is in compliance with GCPs and applicable SOPs, directing appropriate analyses and preparing final reports, and partnering with regulatory affairs as required for filing of FDA documents. Directs preparational revision of clinical study plans, including budgets. Simultaneous direction of management of multi-study plans across each of the marketed products is expected to be the norm; Provides clinical and scientific leadership through interaction with internal and external experts, partners with colleagues across Medical Affairs, JJPRD, Brand Marketing, Regulatory Affairs, PGSM, New Business Development, J&J Corporate Communications, and J&J Legal. Frequently interacts with field based Medical Affairs, participates in promotional copy review and supports medical information services. Participates in appropriate interdisciplinary and intercompany teams; Develop and fosters relationships with thought leaders, scientific societies and advocacy groups. Remains current with and contributes to the scientific literature within field of focus. Key contributor in the development of scientific and communication plans and reviews manuscripts for scientific accuracy and fair balance and Directs the process of post-hoc exploratory analyses and communication of the results. Participates in the decision to fund investigator initiated studies and provides clinical support as required.
Qualifications
MD, DO with at least 2 years of post-doctoral experience in working with psychiatric patients (clinical, academic). In addition, at least 6 years of pharmaceutical industry experience are required that reflect of responsibilities of Associate Director/Director in clinical development. Having a demonstrated ability to manage is a plus. Extensive knowledge of trial design, statistical methods, data analysis, medical writing and safety oversight of patients in clinical trials is required. Work on submission of trials to regulatory agencies is required. Demonstrated conformance with GCP and ICH guidelines and ability to manage multi-million dollar budgets across multiple studies. Record of publication in peer-reviewed medical journals and contribution to professional society or advocacy group is preferred. Experience contributing to the development of scientific and business plans is an asset. Effective interpersonal, presentation and written communication skills are required. Excellence in planning, organization and prioritization. This position may require up to 25% annual travel (mostly domestic but may have some international as well).
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-New Jersey-Titusville
Organization: Janssen Scientific Affairs, LLC (6120)
Job: Clinical Research MD
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Sr. Director, Clinical Development, Psychiatry-6623130904
Description
Janssen Pharmaceuticals, Inc. a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Director, Clinical Development, Psychiatry for the CNS Medical Affairs group, to be located in Titusville, NJ.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Director is responsible for directing the design, conduct and reporting of clinical trials and related activities within the US medical affairs Psychiatry therapeutic area supporting the interests of Janssen Pharmaceuticals, CNS Medical Affairs. Responsibilities include overseeing clinical personnel and frequent interactions with internal and external business partners including regulatory, brand marketing, JRD, PGSM, HECOR, epidemiology, investigators/KOLs in the areas of clinical psychiatric practice, payers and pharmacists. The Senior Director must have the expertise to develop a strategic plan, defend it through J&J management review and direct/create/maintain the processes/interactions necessary to establish and direct this function in accordance with regulatory, corporate and industry standards in addition to effectively managing other Medical Affairs professionals. People leadership responsibilities are a central part of the responsibilities as well as advancing the scientific strategy, goals and objectives CNS Medical Affairs. Reports to the Therapeutic Area Leader, Psychiatry.
Essential responsibilities include: Manage several Associate Directors or Directors of Clinical Development, for guiding work, giving feedback, assessing and conducting performance and potential conversations; Provide scientific expertise, oversight and direction as required for the design, conduct and analysis of clinical trials and commercialization of company products. Specific activities include study design, protocol development, fulfilling the role of medical monitor and ensuring study conduct is in compliance with GCPs and applicable SOPs, directing appropriate analyses and preparing final reports, and partnering with regulatory affairs as required for filing of FDA documents. Directs preparational revision of clinical study plans, including budgets. Simultaneous direction of management of multi-study plans across each of the marketed products is expected to be the norm; Provides clinical and scientific leadership through interaction with internal and external experts, partners with colleagues across Medical Affairs, JJPRD, Brand Marketing, Regulatory Affairs, PGSM, New Business Development, J&J Corporate Communications, and J&J Legal. Frequently interacts with field based Medical Affairs, participates in promotional copy review and supports medical information services. Participates in appropriate interdisciplinary and intercompany teams; Develop and fosters relationships with thought leaders, scientific societies and advocacy groups. Remains current with and contributes to the scientific literature within field of focus. Key contributor in the development of scientific and communication plans and reviews manuscripts for scientific accuracy and fair balance and Directs the process of post-hoc exploratory analyses and communication of the results. Participates in the decision to fund investigator initiated studies and provides clinical support as required.
Qualifications
MD, DO with at least 2 years of post-doctoral experience in working with psychiatric patients (clinical, academic). In addition, at least 6 years of pharmaceutical industry experience are required that reflect of responsibilities of Associate Director/Director in clinical development. Having a demonstrated ability to manage is a plus. Extensive knowledge of trial design, statistical methods, data analysis, medical writing and safety oversight of patients in clinical trials is required. Work on submission of trials to regulatory agencies is required. Demonstrated conformance with GCP and ICH guidelines and ability to manage multi-million dollar budgets across multiple studies. Record of publication in peer-reviewed medical journals and contribution to professional society or advocacy group is preferred. Experience contributing to the development of scientific and business plans is an asset. Effective interpersonal, presentation and written communication skills are required. Excellence in planning, organization and prioritization. This position may require up to 25% annual travel (mostly domestic but may have some international as well).
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-New Jersey-Titusville
Organization: Janssen Scientific Affairs, LLC (6120)
Job: Clinical Research MD
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.