Johnson & Johnson companies are equal opportunity employers.
Associate Director, Clinical Development-0334140508
Description
Ethicon Endo-Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for an Associate Director, Clinical Development. This position will be located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Associate Director, Clinical Development is accountable for all clinical development activities within a large scope of, or an entire business units worldwide. This may include cross-business unit or cross function responsibility. The individual must have the ability to lead teams to ensure evidence generation strategies are developed and activities are successfully completed, taking into account business priorities, resources and budget. Influencing the development of new strategies for the business by gaining support and alignment through effective communication will be critical for this role. A profound interest in understanding how globalization creates both challenges and opportunities is required. Thinking broadly about how to apply strategy to product pipeline and identifying new technologies for the company will be within this remit. The individual will provide a solid scientific basis for new growth opportunities and future product developments. Comprehensive understanding of the business unit vision and looking for opportunities to apply specific technologies to drive business success is required. The individual will be involved with the creation of development opportunities for key associates within Clinical Development.
Essential responsibilities include: Ensure evidence generation and clinical strategies are developed to address the key clinical research questions and support the value proposition for devices, drugs, biologics and combination products in a wide range of surgical/medical specialties; Ensure team develop robust strategies through critical assessment of available evidence (i.e. clinical literature, regulatory submissions, competitive landscape); Leads parts of, or entire business unit clinical strategy development activities, in overarching evidence generation and dissemination strategies; Directs and leads the design and development of clinical study plans including, protocols and their clinical applicability, appropriate statistical design and inputs, resources/structure, budgets, operational excellence, timeline, and reporting; Evaluate clinical data to inform study design, safety, labeling, or reporting decisions; Enables clinical research staff to effectively manage/supervise vendors, including CROs, in the conduct of projects; Demonstrate technical/scientific excellence by directing the design, development of strategies for study / trial reporting, publication planning/development, presentation preparations and other deliverables with limited supervision; Manage inter-and intra-company, and external clinical research partner activities; Independently establish external relationships with KOLs, and cross-functional experts to drive evidence strategies. Actively participate or lead discussions with health authorities; Responsible for career development activities of clinical research managers and project managers, etc.; Accountable for overall implementation, maintenance, and supervision of high standards of research conduct in accordance with departmental SOPs, regulations, and ICH guidance with limited supervision.
Qualifications
A minimum of a Bachelor’s degree in Science or related discipline with 9+ years related scientific/technical experience OR a Master’s degree in Science or related discipline with 7+ years related scientific/technical experience OR a Master’s degree with thesis or a PhD (or MD) in Science or related discipline with 6+ years related scientific/technical experience required; A minimum of 2 years experience at Manager, Clinical Research level with responsibility for project managers executing clinical regulated and /or non-regulated studies and development of clinical development strategies required; Medical, scientific principles and terminology required; Experience with electronic data capture for clinical trials is preferred; Experience with risk-based and central monitoring is preferred; Experience with execution of both US and OUS clinical studies is preferred; In-depth knowledge of regulations and guidance including: FDA / CFR study requirements, GCP/ICH Guidelines in relation to 510K and PMA submissions required; Experience with ex-US study requirements, including European requirements for regulated device studies and drugs preferred; Experience with BLA submissions preferred; Experience in management of complex projects required; Experience managing CRO re: all phases of clinical study implementation and reporting required; Excellent interpersonal, communication and presentation skills required; Excellent Microsoft Word, Excel, and PowerPoint skills required; Medical/Technical Writing skills required; Travel up to 25% required.
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 NA
Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)
Job Function: Clinical Research non-MD
Relocation: Eligible Yes - Within Country
Travel:Yes, 25 % of the Time
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Associate Director, Clinical Development-0334140508
Description
Ethicon Endo-Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for an Associate Director, Clinical Development. This position will be located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Associate Director, Clinical Development is accountable for all clinical development activities within a large scope of, or an entire business units worldwide. This may include cross-business unit or cross function responsibility. The individual must have the ability to lead teams to ensure evidence generation strategies are developed and activities are successfully completed, taking into account business priorities, resources and budget. Influencing the development of new strategies for the business by gaining support and alignment through effective communication will be critical for this role. A profound interest in understanding how globalization creates both challenges and opportunities is required. Thinking broadly about how to apply strategy to product pipeline and identifying new technologies for the company will be within this remit. The individual will provide a solid scientific basis for new growth opportunities and future product developments. Comprehensive understanding of the business unit vision and looking for opportunities to apply specific technologies to drive business success is required. The individual will be involved with the creation of development opportunities for key associates within Clinical Development.
Essential responsibilities include: Ensure evidence generation and clinical strategies are developed to address the key clinical research questions and support the value proposition for devices, drugs, biologics and combination products in a wide range of surgical/medical specialties; Ensure team develop robust strategies through critical assessment of available evidence (i.e. clinical literature, regulatory submissions, competitive landscape); Leads parts of, or entire business unit clinical strategy development activities, in overarching evidence generation and dissemination strategies; Directs and leads the design and development of clinical study plans including, protocols and their clinical applicability, appropriate statistical design and inputs, resources/structure, budgets, operational excellence, timeline, and reporting; Evaluate clinical data to inform study design, safety, labeling, or reporting decisions; Enables clinical research staff to effectively manage/supervise vendors, including CROs, in the conduct of projects; Demonstrate technical/scientific excellence by directing the design, development of strategies for study / trial reporting, publication planning/development, presentation preparations and other deliverables with limited supervision; Manage inter-and intra-company, and external clinical research partner activities; Independently establish external relationships with KOLs, and cross-functional experts to drive evidence strategies. Actively participate or lead discussions with health authorities; Responsible for career development activities of clinical research managers and project managers, etc.; Accountable for overall implementation, maintenance, and supervision of high standards of research conduct in accordance with departmental SOPs, regulations, and ICH guidance with limited supervision.
Qualifications
A minimum of a Bachelor’s degree in Science or related discipline with 9+ years related scientific/technical experience OR a Master’s degree in Science or related discipline with 7+ years related scientific/technical experience OR a Master’s degree with thesis or a PhD (or MD) in Science or related discipline with 6+ years related scientific/technical experience required; A minimum of 2 years experience at Manager, Clinical Research level with responsibility for project managers executing clinical regulated and /or non-regulated studies and development of clinical development strategies required; Medical, scientific principles and terminology required; Experience with electronic data capture for clinical trials is preferred; Experience with risk-based and central monitoring is preferred; Experience with execution of both US and OUS clinical studies is preferred; In-depth knowledge of regulations and guidance including: FDA / CFR study requirements, GCP/ICH Guidelines in relation to 510K and PMA submissions required; Experience with ex-US study requirements, including European requirements for regulated device studies and drugs preferred; Experience with BLA submissions preferred; Experience in management of complex projects required; Experience managing CRO re: all phases of clinical study implementation and reporting required; Excellent interpersonal, communication and presentation skills required; Excellent Microsoft Word, Excel, and PowerPoint skills required; Medical/Technical Writing skills required; Travel up to 25% required.
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 NA
Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Endo Surgery Inc (6041)
Job Function: Clinical Research non-MD
Relocation: Eligible Yes - Within Country
Travel:Yes, 25 % of the Time
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement