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.
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.
You will be responsible for:- 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: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
The anticipated base pay range for this position is :$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
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
