Medical Director Orthopaedics, Spine

Johnson & Johnson Innovative Medicine•Warsaw, IN

21d•Hybrid

About The Position

This role provides medical affairs support within the spine platform. Leading with both outside-to-inside vision to assimilate opportunities of unmet patient and provider needs, and inside-to-outside vision to communicate the medical, surgical, and scientific this role provides strategic input to inform the innovative agenda within the Platform Portfolio. This role provides medical input throughout product development and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential patient safety issues. This role collaborates cross-functionally to support product development, including evidence generation and dissemination to drive market registration, access and adoption. This role supports medical education to internal and external stakeholders, and commercialization activities to drive market adoption.

Requirements

MD or equivalent
Completion of an accredited orthopedic surgery residency
A minimum 1-year fellowship in spine surgery is required.
Candidate must have a minimum of 5 years relevant experience (beyond initial licensure) including clinical practice, dedicated research, or other related training/experience.
Strong understanding of clinical trends and the related healthcare market environment, with deep connections in the digital-, med tech- ecosystem is required.
Background and 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. is required.
Ability to be strong advocate for patient-centric decision making is essential.
Demonstrated ability to build successful relationships & develop partnerships with key business stakeholders & externally with regulators, investigators, etc. is crucially important.
Strong business acumen is essential

Nice To Haves

Previous experience leading in medical affairs, clinical development, or related roles in research / medical device industry is highly beneficial.

Responsibilities

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.
Support business leaders by providing 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.
Provide strategic medical support for operating companies with no dedicated medical affairs personnel (and as requested for those companies with medical teams) including to help drive global innovation agenda through leadership and partnership with the Innovation leaders: Global Strategic Marketing, New Business Development, R&D, Regulatory, Clinical, Quality, & Supply Chain leveraging deep medical expertise.
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.
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.
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.