Associate Director, Translational Medicine Study Responsible Physician- Immunology

Johnson & Johnson Innovative Medicine; Lower Gwynedd Township (Montgomery County); On-site; USD 155,000 - 267,000; Full time

Job summary

An established industry player is seeking an Associate Director in Translational Medicine to lead safety strategies and oversee clinical trials in immunology. This pivotal role involves ensuring patient safety, data integrity, and compliance while collaborating with diverse stakeholders. Join a team dedicated to developing transformational medicines and pioneering innovative healthcare solutions. With a strong focus on patient advocacy, this position offers a unique opportunity to make a significant impact in the field of immunology. If you are a visionary leader with a passion for medical advancement, this role is for you.

Qualifications

• 5+ years in pharma/biotech with clinical trial safety experience.
• Knowledge of global regulatory requirements essential.

Responsibilities

• Lead safety strategies and medical oversight for clinical trials.
• Assess laboratory data and manage subject eligibility.

Skills

Clinical Trial Safety Monitoring

Regulatory Knowledge (ICH, GCP)

Project Management

Communication Skills

Organizational Skills

Education

MD or equivalent physician qualification

Job description

Join to apply for the Associate Director, Translational Medicine Study Responsible Physician - Immunology role at Johnson & Johnson Innovative Medicine.

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; 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 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

Scientific/Technology

Locations

Spring House, Pennsylvania, United States of America, US064; CA San Diego - 3210 Merryfield Row

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 Immunology team leads in developing transformational medicines for immunological disorders and illnesses, aiming to restore health to millions 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 an Associate Director, 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 role is to lead safety strategies, develop medical review and oversight plans, and conduct medical surveillance and interpretation of safety findings for clinical pharmacology and early development studies, ensuring patient safety, data integrity, and protocol compliance.

Responsibilities include providing medical leadership for studies, designing and executing clinical trial protocols, overseeing safety monitoring, and collaborating with various stakeholders to operationalize studies efficiently.

Principal Responsibilities

• Medical oversight for clinical trials, including safety review and risk assessment.
• Managing actions related to subject eligibility and safety.
• Assessing laboratory data and pharmacodynamics results for safety signals.
• Reviewing clinical data, adverse events, and adverse drug reactions.
• Identifying and mitigating medical risks during trials.
• Developing medical review plans and contributing to key documents.
• Interacting with regulatory authorities and external stakeholders.

Study Responsibilities

• Supporting trial design and execution, collaborating with study teams.
• Developing and presenting protocol and safety documents.
• Serving as the primary medical contact for trials.
• Monitoring trials for safety, data accuracy, and compliance.
• Handling safety reporting and communication.
• Contributing to internal and external study reports and publications.

Qualifications

• MD or equivalent physician qualification.
• Minimum 5 years of pharma/biotech experience, including clinical trial safety monitoring.
• Experience in early clinical development and pharmacovigilance preferred.
• Knowledge of global regulatory requirements, ICH, GCP.
• Strong communication, organizational, and project management skills.
• Ability to work independently, under pressure, and in a matrix organization.

The anticipated base pay range is $155,000 - $266,800, with eligibility for performance bonuses and comprehensive benefits. For more details, visit https://www.careers.jnj.com/employee-benefits.

Johnson & Johnson is an Equal Opportunity Employer. We value diversity and inclusion and provide accommodations for applicants with disabilities. For assistance, contact [e-mail].