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Global Head, Medical Affairs (ESD/TSD)

Req ID:  2962

Working Location: PENNSYLVANIA, CENTER VALLEY 

 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Global Head of Medical Affairs (Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD)) is part of Medical and Clinical Affairs (MCA) and reports directly to the Global Head of MCA. This position is responsible for establishing and leading the overall global medical and scientific strategy across all Olympus ESD/TSD therapeutic areas (TA), product portfolios, and clinical development programs.

 

As a physician, this role requires applying clinical knowledge and training to lead peer-to-peer engagements with medical experts and be responsible for managing the TA Medical Affairs team who are responsible for driving medical innovation, identifying clinical insights, and validating the value propositions for Olympus’ products.

Job Duties

* Develops, coordinates, prioritizes, and executes the overall global medical strategy across TAs (including GI/ET, RESP, URO, SUR, SD, ENT, GI, and SE) and product development.


* Conceives, develops, and implements strategies to support Olympus’ strategic and financial goals by building productive professional relationships with the medical community to identify unmet customer needs and promising business opportunities involving emerging medical and health care practices.


* Provides medical/scientific input into Business Development, R&D, marketing, and ESD/TSD strategies, based on her/his medical expertise, and guides teams to understand what is medically important in product design, development, and lifecycle management.


Leads strategy development for clinical evidence development in close collaboration with the Global Head of MCA, Global Head of Clinical Affairs, and the Global Head of Operations Center of Excellence.


* Provides global medical leadership to ensure alignment of MSA strategies and activities across all phases of product development, including preclinical and clinical studies, market access, professional education, and product safety to ensure MSA objectives are fulfilled.


* Develops and executes strategic communication plans involving abstracts, presentations, and manuscripts for all ESD/TSD products involving Olympus-sponsored clinical studies.


* Develops and accountable for scientific communication timelines and deadlines.


* Ensures compliance with the Olympus publications policy and SOPs, and with external guidelines on good publication practices.


* Develops and manages the operating plan (budget and resources) for Medical Affairs.


* Owns the global Medical Affairs strategy and drives harmonization globally while accommodating for differences in regional implementation.


* Collaborates with, oversees, and prioritizes deliverables from Regional Leads, Medical Affairs, and is accountable for reconciling major regional medical differences that may exist regarding patients, healthcare professionals, and healthcare systems, into respective global ESD/TSD strategies.


* Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety to review clinical evidence and to evaluate a product’s risk-benefit calculus.


* Serves as a medical Subject Matter Expert (SME) expert within Olympus, as needed (e.g., ad hoc review of promotional materials, contribute to development/adaptation of medical materials, such as CERs, presentations, trainings, medical briefs and talking points).


* As a member of the MCA leadership team, is responsible for contributing to the MCA mission and objectives, and strategy over a 3- to 5-year time horizon and is accountable to the Global Head of MCA.


* Develops and works to continually improve Medical Affairs’ infra-structure, including development of SOPs, best practices, and training and workshops.


* Provides leadership, career development, coaching and mentoring to direct reports as well as developing a succession plan.


* Supports Medical Safety function in risk management and medical safety.


* Other duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS

* Medical Doctor (MD), or non-US equivalent of M.D.

 

* Minimum of 3 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in late-stage 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.

 

* Domestic and international travel 40%, including weekend and evening travel as needed.

 

PREFERRED QUALIFICATIONS

Demonstrated success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.


* Demonstrated track 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.


* Demonstrated ability to understand current evolving environmental and market access issues.


* Demonstrated success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.


* Strong knowledge and application of ICH E6 (R2), ISO 14155:2020, GxP global regulations and good document management practices preferred.


* Direct people management experience and managing teams.


* Ability to think strategically, critically analyse 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.

 

* Demonstrated 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.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,500 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
 

Olympus…True to You. True to Society. True to LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || 


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