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 DESCRIPTION:

About Innovative Medicine
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
About Immunology
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.
Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Johnson & Johnson is recruiting for a Senior Manager, Study Responsible Physician (SRP) Immunology Translational Sciences and Medicine (TSM) to be located in Spring House, PA, Cambridge, MA, San Diego, CA.
The primary focus of this Senior Manager, Study Responsible Physician (SRP) position within the Immunology Translational Science and Medicine (TSM) department is to lead the safety strategy; develop the medical review and oversight plans and conduct medical surveillance and interpretation of safety findings for clinical pharmacology (CPP) and Early Development (ED) studies as outlined in the asset clinical development plan (CDP) to ensure patient safety, data integrity, and protocol compliance.
For TM Accountable studies the TM SRP will provide medical leadership to the study teams, including leading the design and execution of clinical trial protocols, the strategy for medical review and conduct medical surveillance and interpretation of safety findings and communication of results to TSM leadership, and CDT (compound development team) as needed. For CPP accountable studies, the TM SRP will partner with the CPP lead, overseeing the clinical aspects of study design, protocol development and execution, being accountable for the medical monitoring and safety strategy of these trials.
This work is at its core a deep collaboration between Disease Area experts, CPP, Clinical and Non-Clinical Safety, Translational Science (Biomarker), Translational Medicine (Clinical) experts, Immunologic Pathway experts and other relevant stakeholders at the CDT. The TM SRP collaborates with Global Development Operations (GDO) and the entire Trial Team to operationalize studies efficiently and effectively.

QUALIFICATIONS - EXTERNAL

• Physician (MD or equivalent required).
• Minimum of 5 years pharma/biotech industry experience; or relevant equivalent clinical; or relevant laboratory research experience
• 3 years or more of clinical experience. Relevant work experience as Medical Monitor, and/or pharmacovigilance and/or drug safety officer in a CRO, pharma/biotech.
• Demonstrated experience in clinical trial safety monitoring, Adverse Event reporting, and data review, and related regulatory interactions/response
• Early Clinical Development and Clinical Pharmacology experience is preferred.
• Knowledge of global regulatory requirements, ICH, GCP and clinical trial terminology is required.
• Ability to survey and interpret scientific literature related to assigned projects is required.
• Excellent written and verbal English communication and presentation skills is preferred.
• Working knowledge of the use of Microsoft suite of software products including Excel, PowerPoint, and Word. The ability to do more complex data analysis with Excel or similar programs is a plus.
• Leadership and interpersonal skills. The ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion is highly preferred.
• Good sense of cultural sensitivity and diversity.
• Project and time management skills are 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 is a plus.
• The ability to work in a matrix organization with (virtual) cross-functional teams is required.
• Ability to operate independently or with limited day-to-day supervision is required.
• Ability to work under pressure to meet deadlines.
• Ability to handle complex projects and to overcome delays and obstacles is highly preferred.
• Willingness and ability to travel, including trans-Atlantic travel if applicable.
  The anticipated base pay range for this position is: $155,000 - $$266,800
  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
  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 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
  Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
  

  LI-Hybrid

LI-Onsite

PRINCIPAL RESPONSIBILITIES:

• Medical Monitoring (MM): Provide medical oversight for clinical trials. Functions as the clinical lead with SRP and/or MM role responsibilities on clinical pharmacology and other ED studies, as needed.
• Eligibility Reviews: Manages actions to be taken during a study as they relate to subject eligibility and safety. Ensure that participant eligibility meets study criteria and provide guidance on any medical issues that arise.
• Lab Reviews: Assess laboratory data and pharmacodynamics results to identify any safety signals or concerns
• Data Review: Review clinical data, adverse events, and adverse drug reactions in collaboration with the clinical
• Safety Oversight: Identifies and assesses medical risks and mitigation plans prior to and during clinical trials. Provide medical guidance on patient safety, including reviewing serious adverse events (SAEs) and any necessary clinical interventions.
• Follows Johnson & Johnson SOPs for the SRP function including development of medical review plans; medical input and development of protocol elements document (PEDs), protocols, Informed Consent Form (ICF), Case Report Forms (CRF), Top Line Results (TLRs), Clinical Study Reports (CSRs); owner of safety sections of key documents (DSURs, CSRs, briefing books, etc.)
• Evaluates safety in support of dose escalation, safety data reviews, and decision making.
• Interacts with regulatory authorities and external stakeholders (study Investigators/ /Vendors)
• May participate on early development CDTs to contribute to and communicate strategic asset information relevant to the study design and at key meetings (e.g., CDT, Protocol Review Committee (PRC), First in Humans Early Development Committee (FIHEDC)

STUDY RESPONSIBILITIES:

• Supports the design and execution of assigned clinical trials and works closely with cross functional study team members.
• Collaborates cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee, Protocol Review Committee meetings (PRC) and early clinical development team (TSM) meetings as required.
• Primary medical / safety contact for assigned clinical trials, ensuring protocol adherence by internal and external investigators and study teams.
• Serves as the primary contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and clarification.
• Engaging with investigators and monitoring clinical trials to ensure participant safety, data accuracy, and protocol compliance, addressing medical issues as they arise.
• .
• Ensures study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and Johnson & Johnson standard operating procedures.
• In collaboration with Data Management/Programming, develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with assigned protocols
• Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion with TSM Leadership.
• Responsible for study-related review, assessment, escalation, documentation, and reporting of identified adverse events (AEs), serious adverse events (SAEs), and other safety-related events.
• Communicates SUSAR case digests with GMS and/or other SRPs.
• Performs routine (e.g., biweekly or monthly) AE and CM coding reviews.
• Reviews SAE/severe AE case studies with principal investigators as necessary.
• Responsible as an owner of safety sections of key documents and assures the overall integrity of the data presented such as CSRs.
• Presents trial design, trial conduct updates, and top line results for assigned studies to management.

In collaboration with other functions in GDO:

• Participates in study feasibility, CRO/site selection, trial preparation, initiation, conduct, monitoring, and database locks.
• Reviews incoming data from the study for accuracy and completeness; responsible for data review in conjunction with other clinical team members prior to database locks (iDARTS/Spotfire, listings etc.)
• Supports the assessment and review of clinical safety data from studies by collecting and summarizing appropriate safety data/information for review by the Molecule Responsible Physician (MRP) and/or Safety Management Team (SMT).
• Reviews and interprets clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
• Lead development of clinical contributions to internal documents and presentations for assigned studies; including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, Briefing books, scientific advice meetings, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts)