Preclinical Research Associate Director

Biopharma Careers; Irvine (CA); Hybrid; USD 137,000 - 236,000; Full time

Benefits offered by this job

Vacation time

Sick time benefits

Job summary

Johnson & Johnson MedTech in Irvine, CA, is seeking a Preclinical Evidence & External Partnerships Associate Director in a hybrid role. You will drive pre-market evidence generation strategies and physician collaborations to advance cardiovascular programs and patient care.

Ideal candidates have a PhD or Master’s, 8+ years in Medical Affairs, 2+ years of people leadership, and experience with global regulatory submissions for medical devices or biologics. Travel up to 25% may be required.

Qualifications

• Bachelor’s degree in Biological Science or related field required; advanced degree strongly preferred.
• At least 8+ years of related scientific and technical experience in Medical Affairs or similar; 2+ years of people management experience.
• Experience in Cardiovascular/Electrophysiology or Structural Heart preferred.
• Experience supporting global regulatory submissions for medical devices, biologics, or drugs is highly desired.

Responsibilities

• Ideates preclinical evidence strategies to support first-in-human use for portfolio programs.
• Manages preclinical external research programs and physician partnerships with cross-functional teams.
• Reviews new study proposals, ensures timely decisions and execution with external stakeholders.
• Uses program data to review progress and updates to leadership.
• Supports dissemination strategy through external research programs and publication planning.

Skills

Analytical Reasoning

Medical Affairs

Strategic Thinking

Leadership

Clinical Research

Education

Bachelor's degree in Biological Science

Advanced degree (Master's or PhD)

Job description

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 jnj.com

Job Function: Medical Affairs Group

Job Sub Function: Medical Affairs

Job Category: People Leader

All Job Posting Locations: Irvine, California, United States of America

Job Description

Johnson & Johnson MedTech, Electrophysiology, is recruiting a Preclinical Evidence & External Partnerships Associate Director. This position is located in Irvine, CA and will be following a hybrid model.

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.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose

The Preclinical Evidence & External Partnerships Associate Director will drive pre-market evidence generation strategies (EGS) and physician collaborations. In collaboration with cross-functional teams and external research investigators, this role will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives.

Responsibilities

• Ideates preclinical evidence strategies to support first-in-human use for all portfolio programs
• Manages the preclinical external research program and physician partnerships in coordination with cross-functional clinical science partners
• Responsible for new study proposal review, ensures timely decision making and execution of approved studies including while working with external stakeholders
• Utilizes program data and metrics to conduct regular reviews of the program and provides updates to team leadership
• Supports evidence generation and dissemination strategy through external research program, including alignment of publication plan and identifies gaps
• Drives publication development with investigators and internally cross functionally with scientific affairs partners.
• Provides critical scientific input to publications
• Contributes to preclinical protocol development for all portfolio products
• Provides input to external physician partners on proposed preclinical research plans

Qualifications / Requirements

• Minimum of a Bachelor’s degree in Biological Science or a related discipline is required; Advanced degree (Master’s or PhD) is strongly preferred.
• At least 8+ years of related scientific and technical experience, including leadership or management role within Medical Affairs or a similar role is required.
• A minimum of 2 years of people management-related experience is required.
• Experience working in Cadiovascular, Electrophysiology, or Structural Heart is strongly preferred.
• Expertise in preclinical science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and clinical trial regulations is required.
• Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including IDE/510(k)/De Novo/PMA and/or their global counterparts) is highly desired.
• Ability to lead a team of preclinical scientists to provide strategic and scientific research input across NPD projects is required.
• Proven track record of contributing to medical programs on time, within budget and in compliance to SOPs and regulations is required.
• Up to 25% domestic and international travel may be required.

Required Skills: Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization, Product Strategies, Scientific Research, Strategic Thinking, Team Management

Preferred Skills: Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization, Product Strategies, Scientific Research, Strategic Thinking, Team Management

Base Pay

The anticipated base pay range for this position is : $137,000.00 - $235,750.00

Benefits

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 Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.