Johnson & Johnson MedTech is recruiting a Senior Director, DePuy Synthes, Medical Affairs, TECA located in West Chester, PA

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 https://www.jnj.com/.

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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

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This Senior Director provides medical affairs leadership for the Trauma, Extremities, Craniofaciomaxillary, and Animal Health (TECA) platform within J&J MedTech - Orthopedics. Leading with an outside-in vision to assimilate opportunities of unmet surgical needs, this role provides strong strategic input to inform the innovative agenda across Platform Portfolio. This role leads the Medical Affairs team for the Platform, providing independent medical input throughout product development and life-cycle management, including critical evaluation of clinical risk and input into critical business decisions regarding potential patient safety issues. This leader collaborates cross-functionally to support product development, including evidence generation and dissemination that drive market registration, access, and adoption. This role supports medical education to internal and external stakeholders, and commercialization activities to drive market adoption.

Tasks/Duties/Responsibilities

INSIGHT MANAGEMENT AND BUSINESS DEVELOPMENT SUPPORT

• Engage with omni-channel external sources of information (key opinion leaders, medical societies, literature, social media, etc.) to capture, assess, and translate opportunities of unmet patient and provider needs and trends in the medical/healthcare ecosystems.

• Gather and assimilate input from Medical Affairs leaders across key markets.

• As a critical member of the Platform Leadership Team, provide medical and scientific expertise and omni-channel insights to help shape optimal business development strategy and targets, including product launches, key scientific meetings, relationship management with leading research physicians, critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.

• Validate Target Product Profiles across the assigned innovation pipeline, including gathering and assimilating input from Medical Affairs leaders across key markets.

INTERNAL PROCESS SUPPORT

• Work with cross-functional partners, including but not limited to R&D, Clinical Affairs, Regulatory Affairs, Health Economics & Market Access (HEMA) and Marketing to provide leadership with product development and commercial plans to support product launch, training content and delivery.

• Provide medical/surgical/scientific insights into design requirements, concept, and prototype testing.

• Provide input into risk management processes for hazard/harm identification & risk mitigation.

• Assess device performance, including clinical benefits and safety profile, to evaluate the appropriate Risk-Benefit balance to support market registration and throughout life cycle.

• Work with Medical Safety and Post-Market Surveillance to assess, analysis and interpret events, complaints, signals and trends from clinical studies, literature, complaints, etc.

• Provide medical/surgical/scientific support for external regulatory inspections and audits, and internal audits.

• Provide expertise to support addressing complex medical information requests.

• Provide physician perspective, advice, guidance, and expertise as a medical expert for non-MD colleagues in medical affairs in matters requiring escalation or medical consultation.

• Provide expert medical/surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications.

EVIDENCE GENERATION and DISSEMINATION SUPPORT

• Assist medical evidence generation leaders to develop and execute global strategies for evidence generation for new and existing products, including medical interpretation of clinical analyses, and in the review and approval of clinical study reports and scientific articles (abstracts, manuscripts, etc), in order to support regulatory approval/clearance, health technology assessment, customer access, medical safety and post-marketing support.

LIFE CYCLE MANAGEMENT (LCM) SUPPORT

• Provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups.

• Research, prepare and document responses to Medical Information Requests from Healthcare providers; review and approve medical content in Copy Approval process; and consults with Franchise Medical Director when needed.

• Provide consultation in support of literature review, analysis, and conclusions for Clinical Evaluation Reports (CER) and provide review of CERs and assists in preparation of periodic safety reports for assigned products.

• Assist in reviewing of risk evaluation (PRE or PRA) documents.

• Lead, mentor and coach a team of Medical Affairs professionals.

Qualifications

Requirements

• Must have an MD or equivalent.
• Completion of an accredited orthopedic surgery residency and a minimum 1-year fellowship in orthopedic trauma surgery is required.
• Candidate must have a minimum of 10 years relevant experience (beyond initial licensure) including clinical practice, dedicated research, or other related training/experience.
• Experience leading in medical affairs, clinical affairs, biomedical research or related roles is required.
• Thorough understanding of clinical trends and the related healthcare market environment, with deep connections in the digital-, MedTech- ecosystem
• Strong background and deep medical expertise in assessment of clinical risk-benefit throughout product development and life cycle management, with deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
• Proven ability to be strong advocate for patient-centric decision making.
• Demonstrated ability to build successful relationships & develop partnerships with key business stakeholders & externally with regulators, investigators, etc.
• Strong business acumen
• 20% Travel - Domestic and International
• At least 2 years of People Management experience
• Board Certification or equivalent in Orthopedic Surgery is preferred.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

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