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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub** **Function:

Clinical Development & Research – MD

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

POSITION SUMMARY:

The Director, Study Responsible Physician (SRP) is responsible for development and execution of medical and scientific strategy for a selected clinical trial(s) in the development program for Milvexian and operational implementation, delivered through effective communication with Cross-Functional Trial Team (CFTT). The SRP provide support to a study senior physician, clinical leader (CL) to deliver a trial(s) in a timely and cost-effective manner or program wide activities and is responsible for site interactions in partnership with the clinical project scientist (CPS) for medical questions and education (including safety management guidelines), protocol development, execution, preparation and ownership of clinical study reports and for the preparation and approval of essential documents for regulatory filings. Performs medical safety data review, including evaluation of adverse events and eligibility of participants for assigned studies. May also be responsible for program wide activities such as interactions with IDMC, clinical events committee. May leads or co-leads CFTT, provides leadership via matrix interactions also includes individuals from project management, operations, regulatory affairs, data management, medical writing, biostatistics, benefit-risk management, pharmacogenomics, drug discovery, early clinical development, clinical pharmacology, clinical operations. The SRP is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.

ESSENTIAL FUNCTIONS:

+ Supervision, and development of junior medical staff assuring diversity of candidates

+ Supports development of clinical development plans and ownership for the design of clinical trials and for the content of clinical study reports

+ Interprets, reports and prepares results of product research in preparation for world-wide health authorities and submissions

+ Responsible for medical monitoring/reporting and safety officer activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment

+ Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting

+ May act 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 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 assessment of medical publications emerging from the Team and its affiliates; Responsible, with appropriate colleagues, for review of Company advertising and promotion

+ Ensures the study is executed within a budget for all project related clinical activities

+ Maintain personal knowledge of assigned therapeutic indication(s)

_This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned._

PRINCIPAL RELATIONSHIPS:

Contacts Inside the Company:

• Trial Clinical Leader

• Members of the Clinical and Indication Compound Development Teams

• Colleagues from project management, operations, regulatory affairs, data management, medical writing, biostatistics, drug safety and benefit-risk management, pharmacogenomics, drug discovery, early clinical development, experimental medicine, clinical pharmacology, clinical operations, health economics, epidemiology, worldwide medical affairs and other scientific and business related disciplines

• Members of the therapeutic area and franchise

Contacts Outside the Company:

• Vendors and CRO contacts.

• Interacts with development partners

• May act, in concert with senior clinical personnel, as a company spokesperson regarding publication of clinical research findings and presentations to relevant FDA advisory committees and review meetings (e.g. pre-NDA meeting).

• May be asked to assess external clinical research proposals involving company products relevant to company's mission.

• The SRP develops, in concert with senior clinical staff, credible relationships with opinion leaders, medical directors, and key regulatory officials.

Supervision:

Senior study physician/Trial Clinical Leader

SUPPLEMENTAL INFORMATION

Education and Experience:

An MD (or international equivalent) is required. Board Certification or Eligibility, experience in a Cardiovascular specialty, Neurology and Stroke trials is preferred.

Additional education: Significant academic or pre-clinical research experience is especially desirable. A minimum of 7 years of highly successful managerial/supervisory experience is an asset. A minimum of 5 years Drug Development experience is required as well as a minimum of 3 years pharmaceutical industry experience. 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 interacting with the FDA is very strongly preferred. Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. Energy and enthusiasm are essential. Experience working in a Matrix environment is required. Up to 15-20% yearly travel is required (International as well as Domestic).

Required Technical Knowledge and Skills:

o Fluent in written and spoken English

o Working knowledge of the use of Microsoft software products including Excel and Word

o Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings

o Knowledge of clinical trial supporting systems

The anticipated base pay range for this position is :

$194,000 - $344,000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits