Sr. Director, Preclinical Research

Johnson & Johnson Innovative Medicine•Irvine, CA

18h•Onsite

About The Position

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 As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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: We are seeking a dynamic and experienced Sr. Director, Preclinical Research, EP to be located in Irvine, CA. The Senior Director of Preclinical Research within the Scientific Affairs Team will lead the preclinical evidence generation necessary to ensure patient safety, product efficacy, and competitive positioning of their electrophysiology products. This leader will collaborate closely with cross functional partners and external partners, actively support the EP business by delivering a state-of-the-art preclinical study program, and focus on talent development and team effectiveness. This leader will serve as a key member of the Scientific Affairs leadership team. The Sr. Director Preclinical will leverage their research, device expertise, and partnering capabilities to help define, guide, and support the scientific vision and strategy for MedTech EP. Partnering closely with the multi-functional evidence teams: Medical, Clinical, and Health Economics, as well as the R&D project teams will be critical. This leader holds overall responsibility for MedTech EP’s industry-leading preclinical evidence organization, focused on innovation and patient safety for all EP platforms.

Requirements

A minimum of an advanced degree in biosciences, medicine, bioengineering, or a related field is required.
A minimum of 5 years experience managing a senior scientific staff in the medical device industry is required.
Extensive knowledge of medical device preclinical requirements for regulatory submissions for FDA and international agencies, like TUV and EU MDR, with proven track record of successful approvals of preclinical submissions to FDA and other international agencies is required.
Extensive experience with interacting and communicating with (international) regulatory agencies around preclinical submission strategies and data is required.
A proved track record of new product introduction and product life cycle management is required.
Ability to partner collaboratively with various functions in a challenging and changing environment is required.
Demonstrated leadership skills to serve as a change agent to identify needs and solutions, implement, and support the transformation of a function is required.
Must possess high emotional intelligence; excellent oral and written communication skills; excellent interpersonal skills for interactions with internal colleagues and external customers.
Ability to lead, inspire and influence a team, functioning in a matrixed structure, through a period of change and in alignment with the strategic direction of the Scientific Affairs leadership team.
Self-reflective and aware of her/his own limitations, open to feedback and self-improvement.
Commitment to building a culture of collaboration and trust with diverse colleagues that reflect the commitment of Johnson and Johnson to diversity, equity and inclusion.
Demonstrated business acumen to understand implications of preclinical decisions
A proven ability to execute and get results through leading others in complex technical organizations whilst leading by example.
Demonstrated ability to build successful relationships and develop partnerships with key business partners and customers/investigators.
A risk-taker who anticipates and mitigates risks or unintended circumstances.

Nice To Haves

A Doctorate degree (e.g., PhD, MD, DVM, or equivalent degree) is strongly preferred.

Responsibilities

Oversee the development and implementation of robust preclinical plans and evidence-based strategies for EP projects that ensure patient safety, minimize risk to product approvals and increase product adoption to our customers.
Drive execution excellence of the preclinical evidence package and support the dissemination of results
Strive to create differentiated value to advance innovation across the EP portfolio.
Provide scientific input and rationale to help identify those projects with the highest potential commercial value and patient benefit, to effectively direct and utilize resources.
Support the new product development pipeline goals through due diligence and scientific evaluations as needed
Promote the Preclinical team’s contribution in the innovation process across the EP platforms.
Connect externally and engage strategically with regulators, customers, thought leaders, CROs and other external partners to anticipate industry trends and unmet needs, facilitate innovation, enhance product development and physician testing of products in preclinical studies.
Prioritize projects, assign resources, and address lifecycle needs across all platforms as they arise, in close collaboration with cross-functional partners and project leadership.
Partner with the R&D and Medical Safety groups to execute product design evaluations and preclinical evidence strategies required for product approval, safety, and product adoption.
Identify appropriate animal and bench top models that may be used to drive product development and safety assessments.
Develop and strengthen the preclinical talent pipeline through recruitment, coaching, and talent development.

Benefits

Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
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.
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year