Global Lead, Medical Affairs, Respiratory

Job Description

The Global Lead Medical Affairs - Respiratory (GLMAR) is a board-certified, fellowship trained pulmonary medicine physician or interventional pulmonologist proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management proficiencies to effectively deliver expert medical guidance to the Respiratory business. Fundamental competencies for this role include:

1. Pulmonary disease state, procedural, clinical, and technological market knowledge & experience
2. Comprehensive medical affairs proficiencies (e.g., practice insights, care delivery, intended use, clinical impact, and intended therapeutic benefit) spanning from ideation to execution across the product lifecycle
3. Capabilities in clinical integration of current and future interventional pulmonary diagnostic/therapeutic technologies to improve equitable access to care while delivering meaningful clinical and economic outcomes. 

The GLMAR is part of the growing Medical Affairs division within the broader Medical and Scientific Affairs (MSA) of Olympus. The intended purpose of this role is to support the Respiratory global leadership team as an applied medicine expert for medical strategy development and to champion the patient and provider prospective. This role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the Pulmonary therapeutic area while simultaneously demonstrating proficiencies in external scientific engagement via peer-to-peer consultations with physicians, payors, professional societies, patient advocacy groups, as well as health system and integrated delivery networks worldwide. The successful candidate will bring a combination of strategic mindset, strong operational involvement (“hands on mentality”), together with a personality of being a team player, humble and inquisitive, along with servant leadership skills and the ability to influence across matrixed internal & external environments.

Job Duties

• Medical Strategy: Provide expert medical and clinical insights to inform the effective development of the Respiratory medical strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives.
• Medical Affairs: This GLMAR is an applied medicine subject matter expert within the Pulmonary therapeutic area responsible for providing medical practice insights, intended use, and anticipated clinical impact. This spans the product lifecycle through all phases of product development (Initial Conceptualization, Product Development, Launch Excellence, Lifecycle Management) and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement.
• Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing applied medicine therapeutic expertise to the clinical team (e.g., practice insights, care delivery, clinical impact assessments, and intended therapeutic benefit).
• Clinical Evaluation: The GLMAR will support the Clinical Evaluation team through consultations on literature search strategy, data appraisal, threshold of performance, and assessment of clinical benefits. Contributing authorship of Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Summary of Safety & Clinical Performance (SSCP) and Periodic Safety Update Report (PSUR) is expected as well as providing input on equivalent comparators, state of the art, to substantiate safety and performance.
• Clinical Care Integration: Demonstrate proficiencies in understanding and facilitating the coordination of patient care, (including care redesign), across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-centric.
• HEMA/HEOR:  The GLMAR will support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriately manner.
• Therapeutic Area Expertise: Support the Respiratory business strategic goals by providing critical insights obtained through productive peer to peer physician and societal scientific engagements.
• Medical Safety: Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, non-conformances, and benefit risk determinations.
• Respiratory Leadership Team: Serve as a member of the Respiratory Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support to the Medical & Scientific Affairs subfunctions in their interactions with the Respiratory global team is expected.
• Business Development: Provide medical/scientific input into Business Development, R&D, marketing, and greater Respiratory business strategies, based on their knowledge and medical expertise. Guide teams to understand what is medically important in digital product design, development, and lifecycle management. Provide integration strategy and operational implementation guidance for acquisitions.

Job Qualifications

Required:

• Medical Doctor (MD) degree, with demonstrated independent clinical practice experience in bronchoscopy and pulmonary interventions
• Minimum of 5 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• Deep knowledge of the Pulmonary therapeutic area and associated interventions as well as global understanding of medical affairs, clinical evidence development and global healthcare delivery systems.
• Success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.
• A record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level.
• Ability to understand current evolving environmental and market access issues.
• Success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.
• Vitality and scheduling flexibility to commit to a global schedule navigating multiple time zones with extended hours into the early morning as well as late evenings (e.g., Eastern Standard Time: UTC-5, Central European Time: UTC+1, and Japan Standard Time: UTC+9)
• Domestic and international travel up to 40%, including weekend and evening travel as needed.

Preferred:

• Additional advanced degrees: PhD, MS, MBA, or MPH desired
• Interventional Pulmonology Fellowship, Pulmonary Medicine, or Pulmonary Critical Care Fellowship
• Interventional Pulmonology Board Certification or Pulmonary Disease Board Certification
• Active participation in a Maintenance of Certification (MOC) program
• Active medical license
• Ability to think strategically, critically assess and synthesize complicated data and scientific information.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.