Johnson and Johnson is recruiting for a Associate Director, Clinical Science; Immunology Therapeutic Area, 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.
At Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus 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.
Johnson & Johnson discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
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Johnson and Johnson Immunology has a history of bringing life-changing therapies to patients with immune-mediated diseases.
Position Overview:
The focus of the Associate Director Clinical Scientist is to support various clinical research tasks associated with assigned Immunology Development clinical trials, providing leadership in program execution, innovation, and optimization of execution. Scope of work will include tasks associated with the execution, monitoring, and reporting results of clinical trials evaluating therapeutics in immunologic disorders. The range of tasks may vary to some degree depending on the therapeutic area and trial-specific requirements.
The Associate Director Clinical Scientist is a key member of development clinical trial teams and leads the team designing and execution of clinical studies in partnership with Project Physician(s). The Associate Director Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The Associate Director Clinical Scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues from different disciplines.
Responsibilities include:
- Performs activities which support the design, execution, monitoring, and reporting of clinical trials.
- Leads preparation of clinical development plans, trial protocols, case report forms, study operational plans
- Performs medical monitoring and reporting in partnership with Study Responsible Physician, evaluates clinical trial adverse events, reviews clinical laboratory results, drafts adverse event narratives.
- Builds credible relationships with clinical investigators, medical/scientific experts
- Partners with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting
- Assists Data Management with the review of clinical data and query resolution
- Works closely with Quality Management & Assurance to ensure flawless execution of clinical trials
- Drafts and coordinates completion of clinical study reports
- Drafts responses to questions from Ethics Committees and Health Authorities
- Supports integrated document development for marketing authorization filing
- Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
- Supports preparation for the FDA Advisory Committee and EU Oral Explanation
- Reviews medical literature and related new technologies
Qualifications
- BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 8 years industry experience or equivalent clinical research experience is required.
- Experience in late-stage drug development, experience in immuno-inflammatory indications is preferred.
- Ability to survey and interpret the scientific literature related to the assigned projects is required.
- Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
- Good interpersonal skills and the ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.
- Excellent written and verbal English communication skills.
- The ability to work in a global matrix organization with cross-functional teams is required.
- Proficient with Microsoft Office applications EXCEL, POWERPOINT, and WORD.
- 10-20% domestic/international travel may be required.
he anticipated base pay range for this position is 137000 to 235750. California Bay Area - The anticipated base pay range for this position is 168000 to 271400.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. • Please use the following language:
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company's long-term incentive program.
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
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.
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.
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