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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Senior Feasibility Strategy Leader / シニア・フィージビリティ・ストラテジー・リーダー(東京・大阪・神戸・在宅)

Job ID R0000005046 Japan, Remote

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

関係部門と連携をとりながら、クライアントへのプロポーザル作成に際して、最適な試験実施戦略を提案し、新しいビジネス獲得に貢献するポジションです。

具体的には、クライアントのニーズに応じて社内・社外のデータを分析、状況に応じて試験実施国や施設、患者を洗い出し、患者募集戦略の提案を行います。

※当該ポジションは管理職です。

<業務内容>

  • プロポーザル作成チームと協力して、それぞれの試験の戦略的なシナリオを提案する。プロポーザル作成依頼書や想定される質問に関しても細かくレビューし、クライアントがCRO選定の際の条件や重要な要素を理解する。
  • 社内、社外のデータを分析し、試験実施国や施設、対象患者の登録に要する期間等の患者登録のシナリオ作成のベースを見積る。クライアント特有の想定される課題やリスク等を明らかにする。
  • 試験の全体的な性質を認識するとともに、患者のプロフィールを理解し、どこで患者が見つかったのか、患者が試験に参加する際の障壁やきっかけを明らかにし、メディカルドクターと共有する。
  • ツールを使用して試験実施国の分析を行い、確実で理にかなったデータ分析により、プロトコールに沿った推薦国を提案する。
  • 一つの国における施設数や最大の患者数が期待できる施設を特定する為に、最適な戦略を明確にする。
  • 患者登録を成功させる為の戦略開発をリードし、合意を得た戦略に基づいてツールを使用し運用する。
  • 社内ミーティングにおいて、提案する戦略や登録シナリオを明確に伝える。
  • クライアントニーズを考慮し、最適な運用プランにあった説得力のある戦略のプロポーザルを作成する。
  • 試験実施について、国や施設の選定、最適なシナリオ戦略をプレゼンテーションする準備を行う。
  • ビッドディフェンスミーティングに参加し、総合的な戦略を売り込み、新しいビジネス獲得に貢献する。

<応募条件>

求める知識・経験、資質:

  • メーカーやCROでの開発経験
  • 施設立ち上げ業務、フィージビリティ調査経験歓迎
  • ビジネスニーズに応じた分析能力
  • 問題解決能力、顧客目線
  • リーダーシップ、周囲へ影響力を与える能力
  • コミュニケーション能力 (良好な関係構築、プレゼンテーション能力、口頭や文書でのコミュニケーション)
  • ビジネスレベルの英語力 (読・書・会話) 
  • ビジネスレベルの日本語力 (読・書・会話)

Essential Functions

The Feasibility & Strategy Leader (FSL) acts as a key contributor to the proposal team to support Parexel in winning new business.  Working independently with limited supervision from management, the FSL is responsible to deliver, in collaboration with Patient Recruitment Strategy (PRS) and Site Alliance (SA) groups, an optimized integrated strategic approach to target the right countries, right sites, and right patients for Request for Proposals (RFPs) on all types and phases of studies.  The FSL must demonstrate good communication and time management skills resulting in the completion of all deliverables within required timelines meeting proposal team needs and departmental quality standards.  Good analytical and writing skills are a pre-requisite to the job to allow FSL to fully adopt a consistent data-driven approach to feasibility and deliver clear, concise, selling proposal texts.

Key Accountabilities

  • Maintain collaboration with the virtual RFP team to take active role in creating and presenting integrated strategy for scenario planning for each study.  Through in-depth review of the RFP documents and ad-hoc follow-up questions, ensure a full understanding of customer requirements for the proposal as well as key drivers for CRO selection decision.
  • Conduct high level recruitment benchmark data analysis to estimate the basic foundations for the enrolment scenario building, namely range of countries and sites as well as months of recruitment required to enroll the target patients. Identify potential challenges/risks associated with Sponsor specifications if any.
  • Understand the patient profile and where these patients are found in the healthcare section, recognizing the global nature of the study.  Identify site and patient barriers and motivators to participate in this study.  This should be discussed with the study assigned MD for confirmation or questions.
  • Determine and operationalize relevant pre-award feasibility services required to support and/or back-up PAREXEL strategic delivery plan to conduct the trial in order to positively influence Sponsor award decision.
  • Conduct country selection analysis via available country selection tool/platform and deliver protocol-specific country recommendations including solid data-driven rational.
  • Define optimal strategy for site identification that would allow maximizing number of patients per site as well as number of sites per country.
  • Lead the development of an integrated operational strategy to successfully recruit patients for clinical trials and deliver enrolment scenarios aligned to the agreed strategy utilizing available modeling tools and techniques.
  • Articulate and defend the proposed strategy and enrolment scenario models in PAREXEL internal meetings.
  • Develop strong selling proposal text to deliver the agreed compelling strategic approach to meet PAREXELs optimum delivery plan taking into account Sponsor specific requirements.
  • Prepare compelling slides to present the strategy for study delivery, country and site selection, and optimized scenario plan.
  • Attend Bid Defense Meetings and sell the integrated strategy to Sponsor to support the winning of new business.

Skills & Competencies

  • Strong analytical skills applied to business needs
  • Excellent interpersonal, presentation, verbal and written communication
  • Demonstrated leadership capabilities, and ability to influence others
  • Problem-solving skills allowing Client focused approach to work
  • Ability to multitask to tight timelines prioritizing workload and maintaining high quality standards
  • Willingness to work in a matrix environment, work independently and part of a dynamic team and in a decentralized reporting model (as applicable)

Education

  • Scientific degree, Registered Nursing degree or comparable life skill experience, Master’s degree, MD, or PhD preferred.

Language Skills

  • Fluent in written and spoken English

Minimum Work Experience

  • Relevant clinical research experience in international clinical trials.
  • Demonstrated expertise in scientific report writing, independent research and data analysis.

#LI-REMOTE

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