Sr. Director, Preclinical Research

Role Summary

Senior Director, Preclinical Research, EP — based in Irvine, CA. Lead preclinical evidence generation to ensure patient safety, product efficacy, and competitive positioning of electrophysiology products. Collaborate with cross-functional teams (Medical, Clinical, Health Economics, R&D) and external partners to deliver a state-of-the-art preclinical program, and focus on talent development and team effectiveness. Serve as a key member of the Scientific Affairs leadership team to shape the scientific vision and strategy for MedTech EP and support innovation across EP platforms.

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.

Qualifications

• Required: A minimum of an advanced degree in biosciences, medicine, bioengineering, or a related field is required.
• Required: A minimum of 5 years experience managing a senior scientific staff in the medical device industry is required.
• 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.
• Required: Extensive experience with interacting and communicating with (international) regulatory agencies around preclinical submission strategies and data is required.
• Required: A proved track record of new product introduction and product life cycle management is required.
• Required: Ability to partner collaboratively with various functions in a challenging and changing environment is required.
• 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.
• Required: Must possess high emotional intelligence; excellent oral and written communication skills; excellent interpersonal skills for interactions with internal colleagues and external customers.
• Required: 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.
• Required: Self-reflective and aware of her/his own limitations, open to feedback and self-improvement.
• Required: 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.
• Required: Demonstrated business acumen to understand implications of preclinical decisions.
• Required: A proven ability to execute and get results through leading others in complex technical organizations whilst leading by example.
• Required: Demonstrated ability to build successful relationships and develop partnerships with key business partners and customers/investigators.
• Required: A risk-taker who anticipates and mitigates risks or unintended circumstances.
• Preferred: A Doctorate degree (e.g., PhD, MD, DVM, or equivalent degree) is strongly preferred.

Skills

• Required: Global Regulatory, Preclinical Research, Regulatory Requirements, Regulatory Submissions
• Preferred: Clinical Development, Clinical Research, Clinical Studies, Clinical Trials, Early Clinical Development, Pre-Clinical Developments

Additional Requirements

• Travel: Up to 35% domestic and international travel.