Senior Clinical Scientist

研究開発

職務内容／Job duties	（雇入れ直後 / Immediately after hiring） ■PURPOSE/SUMMARY The Sr. Scientist collaborates closely with the leadership of Clinical Affairs to execute clinical strategy activities and oversee aspects of clinical studies in support of clinical evidence generation strategies across the AI business unit portfolios. This individual will participate in the development, execution, and closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus’s portfolio. Specifically, this individual will be responsible for writing clinical study protocols, case report forms, and study reports; will work closely with study sites to obtain necessary approvals (EC/IRB); and will respond critically to questions raised throughout the clinical study execution. The individual is a critical member of Clinical Affairs strategy team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across different business units, and within the broader Olympus organization, as appropriate. ■PRIMARY DUTIES AND RESPONSIBILITIES ・In collaboration with internal and external to MSA stakeholders, contribute to an evidence generation strategy that will drive the clinical evidence strategy for OLY business units ・Provides critical input into Business Development, R&D, and product development project (PDP) activities to inform decision-making on whether clinical evidence supports a product’s value proposition. ・Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans. ・Participate in clinical trial design (protocol and CRF development), execution (data collection, analysis, and interpretation), and closeout (final reporting). ・Oversee execution of Investigator Initiated Trials (IIT) and Collaborative Clinical Research (CCR) initiatives. ・Present clinical study updates to internal and external stakeholders; support Publication strategies. ・Support Regulatory submissions. ・Facilitate communication between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs, and investigational sites. ・Ensures clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. ■SUPERVISOR RESPONSIBILITIES The Sr. Clinical Scientist is an individual contributor and will have no direct reports. （変更の範囲 / Scope of change）会社の定める業務 Business as defined by the company
応募資格／Qualifications	【MINIMUM QUALIFICATIONS】 ■Education ・Required: BA/BS degree in life sciences or related field ・Highly Preferred: Advanced degree in life sciences, medicine or related field ■Experience ・8+ years medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within biotech industry. ・Experience working on evidence generation strategies. ・Ability to think strategically, critically analyse and synthesize complicated data and scientific information. ・Demonstrated scientific writing ability. ・Ability to plan and organize project assignments of substantial variety and complexity. ・Ability to be innovative, resourceful, and work with minimal direction. ・Ability to work within a team and as an individual contributor in a fast-paced, changing environment. ・Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. ・Demonstrated ability to engage with external stakeholders; build and maintain relationships with key opinion leaders, investigators, and research staff. ・Strong organizational and follow-up skills, as well as attention to detail. ・Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration. ・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. ■Other Considerations (travel/hours availability, etc.) ・Domestic and international travel up to 5-10%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships. ・Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings. 【COMPETENCIES】 ■Core Competencies ・Organizational Savvy: Understands how work gets done in matrixed organizations; builds productive relationships that allow him/her to efficiently drive projects; maintains a results orientation within constraints of formal organizational policies and rules. ・Customer Focus: Builds productive relationships with internal and external stakeholders; stays cognizant of stakeholder needs, concerns and satisfaction; responds promptly to stakeholder questions and requests; effectively manages stakeholder expectations. ・Situational Adaptability: Adapting communication styles to promote cooperation. Maintains a positive attitude in the face of change; appropriately adjusts behaviour and activities to changing conditions in the business environment. Demonstrate resilience and professionalism when dealing with challenging situations. ■People Competencies ・Driving for Results: Foster a positive team culture by leading with optimism and encouraging a can-do attitude. Motivate team members to overcome obstacles and stay focused on shared objectives. Work towards and achieve organizational objectives, maintaining focus and determination.
待遇／Salary & Benefits	【雇用形態】正社員（試用期間3ヶ月：待遇の変更はなし）【勤務時間】 8：45～17：30 （休憩：昼45分）　標準労働時間8時間 ※フレックスタイム制度あり/コアタイム無し（管理職採用の場合対象外） ※時短勤務制度あり ※テレワーク勤務あり・時間外労働あり【休暇・休日】・休日　　：土日祝、年末年始、GW、夏期休暇・年間休日：129日（自社カレンダーに応ず）・有給休暇：20日間の年次有給休暇を付与。 ※入社初年度は入社月にて変動します（最大20日） ※時間単位での取得も可能です（一部条件有）・育産休暇：取得実績あり（2022年度育児休暇取得率：女性94％※1、男性70.2％）・特別休暇：結婚、出産、忌引き、転勤　など・私傷病特別休暇・治療との両立に伴う特別休暇（厚労省が支援を推奨する疾病に対して、特別休暇を付与）・リフレッシュプラン ※対象年度の出産者の育児休業取得率は100％であるが、出産者の産後休暇が期間内に含まれるため94％となっています。【手当】交通費支給、次世代手当（管理職採用の場合対象外）、在宅勤務手当など【保険】社会保険完備（雇用保険、健康保険、厚生年金、介護保険、労災保険）【福利厚生】※1 退職金制度：確定給付企業年金、確定拠出年金育児サポート：企業内託児所、出産祝い金、ベビーシッター補助※2 その他：従業員持株会、財形貯蓄、カフェテリアプラン※3、社内食堂、社外シェアオフィス、健康診断※4、団体保険 ※1）記載の福利厚生については各種規定、条件がございます ※2）内閣府企業主導型ベビーシッター利用支援事業 ※3）自己啓発、健康増進、育児・介護支援など様々なメニューから選択して利用できます ※4）35歳以上の方は健康診断で内視鏡検査を受診する場合は全額補助が出ます
勤務地／Location	（雇入れ直後 / Immediately after hiring） ■グローバル本社（東京都八王子市石川町2951）働く場所は在宅・新宿サテライトオフィス・宇津木事業所・シェアオフィス（社外）なども可能です。活用方法や頻度は部署と職種により異なります。詳細は面接時にご確認願います。新宿サテライトオフィス（東京都新宿区西新宿2-3-1 新宿モノリス）雇用契約はグローバル本社にて締結します。【受動喫煙対策】事業場内禁煙　（変更の範囲 / Scope of change）会社の定める場所( テレワークを行う場所を含む) Workplace determined by the company(including the location where the telework will take place)