Purpose Statement:

To innovative drugs and treatments to patients by providing medical knowledge and experiences for clinical development strategy.

医学的な知識・経験をもとに 臨床開発計画の作成や実施に貢献することにより、日本の患者さんに革新的な新薬及び治療法を届ける。

Major Responsibilities:

An associate medical director provides medical perspectives into the clinical development programs that are discussed by a cross functional team. In addition, Associate Medical Director ensure safety in subjects in a local clinical studies in Japan. For Assistant medical directors, in principle, they work under the oversight of associate medical director and/or a supervisor. Associate and Assistant Medical Director own the below responsibilities:

アソシエイトメディカルダイレクターは、クロスファンクショナルチームにおいて議論される臨床開発プログラムについて、医学的および科学的視点から助言を行う。また、日本で実施する臨床試験において, 被験者の安全性を確保する。アシスタントメディカルダイレクターは、原則、アソシエイトメディカルダイレクター及び/又は上長のアドバイスのもと業務を遂行する。アソシエイト/アシスタントメディカルダイレクターは、それぞれ以下の責務を担う。

1. Provide medical advice in a cross functional team such as Japan product team

クロスファンクショナルチーム(Japan Product Team等)における医学的助言を行う

1-1 Medical inputs into clinical development plan

臨床開発計画における医学的な助言

• Provide medical knowleages during preparation of clinical development strategy plans.

臨床開発戦略に医学的な観点から助言を行う。

• Contribute to interaction with PMDA and key opinion leaders (KOLs) by providing medical and scientific perspectives.

医学的知見による助言を行い、PMDAやKey opinion leaderとの協議に貢献する。

1-2 Medical inputs in execution of clinical study

治験実施中の医学的な助言

• Provide Japanese medical information such as epidemiology data, standard of care, and /or guideline during protocol development

プロトコール作成時において、日本の疫学、標準治療、ガイドライン等の医学的な情報を提供する。

• Provide medical suggestions or inputs regarding safety issues and contribute implementation of global study.

試験実施中の安全管理について医学的な助言を行い試験継続に貢献する。

1-3 Tasks related to NDA and other activities

申請段階及びその他の業務

• Review Japanese CTD (CSE, CSS) and confirm if the contents are medically appropriate.

CTD(CSE、CSS)の確認を行い、内容が医学的に適切か確認する。

• Contribute preparations of query response for PMDA by providing medical knowledge

照会事項対応の際、医学的な助言を行い回答作成に貢献する。

• Attend a meeting led by medical department such as a advisory board meeting prior a drug

approval

承認前にMedicalが主催するアドバイザリーボード等の会議に参加する。

2. Therapeutic Area Medical Director (TA MD) in a GCP related organization

GCP社内組織におけるTAMDとしての役割

• TA MD is responsible for a study design, eligibility criteria, safety management, and safety/efficacy assessments, and also responsble for conducting the study in accordance with the protocol and operation manual.

TA MDは、試験の責任者として、試験のデザイン、適格基準、安全性管理、有効性判断を主導し、プロトコール及びオペレーションマニュアルに従い試験が実施されるよう責任をもつ。

• TA MD is responsible for discussion with PMDA and KOLs

当局及び外部専門医等との検討に責任をもつ。

• TA MD is responsible for the contentes of CSR

CSR作成及び申請における臨床試験成績の記述について責任をもつ。

• Qualifications: 経験/職歴 / Background/Experience Mandatory 必須条件
• Sufficient and medical knowledge in the therapeutic area assigned
• 割り当てられた治療分野における十分な医学的知識
• General knowledge of pharmaceutical association (Seiyaku kyo and Pharma etc.).
• 製薬協会の一般的な知識(製薬協やPhARMA など)
• TOEIC score is 800 or higher, or equivalent skill for English communication.
• TOEIC スコアが800 以上、または英語でのコミュニケーションで同等のスキル Preferable 望ましい条件
• Experience of participating in company-sponsored clinical studies as investigators
• 治験責任医師として企業主催の臨床研究に参加した経験
• Knowledge regarding process of New Drug Application (NDA) and approval from making clinical development plan (PMDA consultation, Protocol preparation, Study management, CTD preparation, response to PMDA queries after NDA etc.) NDA のプロセスに関する知識および臨床開発計画の作成からの承認(PMDA の協議、プロトコルの準備、試験管理、CTD の準備、NDA 後のPMDA からの照会事項対応等)
• Skill スキル
• Leadership リーダーシップ
• Coaching コーチング
• Team building チームビルディング
• Communication skill with English 英語のコミュニケーションスキル
• Background/Experience 経験/職歴
• At least 5 year experience of medical practice (Associate Professor or equivalent is preferable)
• 少なくとも5年の医療行為の経験(准教授または同等の能力が望ましい)
• Having experience in clinical development would be preferable.
• 臨床開発の経験があることが望ましい Education 学歴
• Graduate from Medical School (PhD degree holder is preferable)
• 医学部卒業(博士号取得者が望ましい)
• Qualified Medical Doctor (mandatory)
• 医師免許(必須) Good fit with the ways we work as per below. All4OneAbbvie - Interpersonal Savvy Relates well to all kinds of people, up, down, and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably. Decide Smart&Sure - Dealing With Ambiguity Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty. Agile&Accountable - Managing Vision and Purpose Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision shareable by everyone; can inspire and motivate entire units or organizations. Clear&Courageous - Managerial Courage Doesn't hold back anything that needs to be said; provides current, direct, complete, and "actionable" positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports) quickly and directly; is not afraid to take negative action when necessary. Make Possibilities Real – Planning Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results.

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