Location: Raritan, NJ
Company: Johnson And Johnson
on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Research & Development, LLC. discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension.
Please visit http: // for more information. We are Janssen. 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 Summary The Clinical Leader (CL) is responsible for leading the team for a number of Milvexian level activities across all LIBREXIA clinical trials (IDMC, CEC etc.
) and milvexian safety oversight across the program along with supporting other functional program needs. They will lead the Operational Alignment and Safety Integration Strategy Team (OASIS) for the LIBREXIA program within the CVMRPH Therapeutic Area. They will support the preparation of the compound and trial level documents, such as the Development Safety Update Report, Investigator Brochure, and Health
Authorities and Ethics Committees/Institutional Review Board responses.
In this role they may serve as Molecular Responsible Physician. The CL will lead their team to oversee and support the compound level safety and operational harmonization work across clinical trials, support the Independent Data Monitoring activities, the Joint Safety Monitoring Team and the emergency hotline service, Clinical Events Committee, development, and updates of the Clinical Development Plan within Compound Development Plan. They will contribute to protocol development, preparation of clinical study reports, and for the preparation and approval of essential documents for regulatory filings.
The CL may manage direct reports who are project physicians. They will operate in a matrix environment including external partners, and interact with different functions including project management, operations planning, project direction, regulatory affairs, data management, medical writing, biostatistics, benefit-risk management, pharmacogenomics, drug discovery, early clinical development, clinical pharmacology, clinical operations, health economics, epidemiology, worldwide medical affairs and other scientific and business-related disciplines. The CL is also expected to assist in the leadership of the evaluation of external scientific opportunities in the therapeutic area.
Major Duties & Responsibilities Responsible for medical monitoring/reporting and safety oversight; Evaluates adverse events (pre and post-marketing) for relationship to treatment and works closely with Global Medical Safety. Responsible for program medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment May support or assume responsibility for clinical development plans and participates in the design of clinical trials and development of the content of clinical study reports Interprets, reports and prepares results of product research in preparation for world-wide health authorities and submissions Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting Acts as medical contact at company for worldwide health authorities concerning clinical/medical issues.
Assists Regulatory Affairs in the development of drug/device regulatory strategies May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance May support early clinical development and discovery activities involving product potential and development for registration Participates on evaluation of new product ideas, implement franchise business strategies, etc.
Responsible for backssment of medical publications emerging from the Team and its affiliates; Responsible, with appropriate colleagues, for review of Company advertising and promotion Recruitment, supervision, and development of junior medical staff, assuring diversity of candidates Maintain personal knowledge of assigned therapeutic indication(s) Recruit, supervise, and develop junior medical staff, assuring diversity of candidates Required Knowledge, Skills and Abilities: An MD (or international equivalent) is required.
Board Certification or Eligibility, experience in late development (ie, Phase II/III development experience including interactions with co-development partners) studies with cardiovascular outcomes preferred.
Additional education: Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. A minimum of 10 years Drug Development experience is required, safety review experience is preferred, as well as a minimum of 7 years medical industry experience. Highly successful managerial/supervisory experience is an asset. Also required is Phase II/III development experience including interactions with co-development partners. Worldwide registration experience strongly preferred as well as experience working or with the FDA is very strongly preferred.
Experience working in a Matrix environment and co-development partners is required. Up to 15-20% yearly travel is required (International as well as Domestic). • Fluent in written and spoken English • Working knowledge of the use of Microsoft software products including Excel, Powerpoint, and Word • Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings • Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
• Demonstrated ability to think strategically The anticipated base pay range for this position is $213,000 to $368,900. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.
Additional information can be found through the link below. For additional general information on Company benefits, please go to: - www. careers. /employee-benefits At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.
Management & Executive Jobs refer to positions at the higher levels of an organization's hierarchy, involving significant responsibility over strategic planning, decision-making, and leadership. Executives set visions, goals, policies, and they often participate in high-level negotiations. Managers oversee the implementation of these directives, leading teams, managing resources, and ensuring operational efficiency. These roles demand strong leadership, communication, and analytical skills, as well as extensive experience in their respective fields. Typical titles include CEOs, CFOs, directors, and various department heads, each with a critical influence on the company's success and direction.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
Management & Executive Jobs refer to positions at the higher levels of an organization's hierarchy, involving significant responsibility over strategic planning, decision-making, and leadership. Executives set visions, goals, policies, and they often participate in high-level negotiations. Managers oversee the implementation of these directives, leading teams, managing resources, and ensuring operational efficiency. These roles demand strong leadership, communication, and analytical skills, as well as extensive experience in their respective fields. Typical titles include CEOs, CFOs, directors, and various department heads, each with a critical influence on the company's success and direction.
open development space. You are self-motivated and capable of working both independently and with cross functional teams to guide manufacturers and their products through the process. Your strong technical knowledge, Project Management and communication skills will be used daily in this role.
Evaluate device entries and independently manage approvals Work with cross functional teams on device issues Manage requirement and process changes while communicating them to OEMs that are in process. Educate OEMs as needed Certify device updates PDN-9af3e95e-7b26-41de-bc92-c8d9d923d7cd
