Job Description

General Information

Job Advert Title: Medical Lead, Biopharma

Location: Nihonbashi, Tokyo

Division: Biopharma and Ophthalmology Development

Employment Class: Permanent

Description

【About Astellas】

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. （HP:Learn more about Astellas）　

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

【募集の背景 / Purpose & Scope】

The Global Medical Lead (GML), Biopharma and Ophthalmology Development (BOD), will lead the clinical development of one or more biopharmaceutical research programs at any stage from pre-clinical to approval, especially gene and ribonucleic acid (RNA) therapy. The GML will join a team of physician scientists reporting to the Global Medical Portfolio Lead, Biopharma and support the mission of BOD to create VALUE for patients.

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

The GML will

• oversee ongoing clinical trials to ensure the safety and well-being of clinical trial participants.
• design the overall clinical development plan for their assigned programs.
• draft protocols and supporting documents required to conduct individual clinical trials.
• direct a team of one or more development scientists and/or physicians in pursuit of program goals.
• contribute to global regulatory submissions.
• analyse, interpret, and disseminate clinical trial data internally and externally.
• prepare written and visual materials required for internal decision-making.
• collaborate with personnel from operations, regulatory, biostatistics, project management etc.
• educate and advise internal stakeholders as a subject matter expert in clinical medicine.
• engage with external stakeholders including physicians, regulators, advocates, patients, and caregivers.
• evaluate the clinical development feasibility of new business opportunities.

（変更の範囲）

会社内での全ての業務

【就業環境に関する要件 / Specific Physical or Environmental Requirements】

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
• This position requires approximately 25% travel, including domestic and international travel

【応募要件 / Qualifications】

＜必須 / Required＞

• Doctor of Medicine (M.D.), or equivalent degree from an accredited medical educational institution
• Board certification (active or prior) in a relevant specialty, such as neurology, neurosurgery, or physical medicine and rehabilitation
• Unrestricted medical licensure in one or more jurisdictions
• 3 or more years of clinical practice experience
• 3 or more years of biopharmaceutical industry experience
• Proficiency with written, visual, and oral communication of medical knowledge
• Proficiency with Microsoft Office (Word, Excel, Power Point, One Note, Outlook, Share Point, and Teams)
• Proficiency with accessing, reading, and interpreting primary medical and scientific literature
• Proficiency with work in a cross-functional, matrixed, work environment
• Proficiency with people of diverse cultural backgrounds and geographic origins
• Working knowledge of biostatistics
• Fluent in written and verbal English
• Valid identification and up-to-date vaccination history to facilitate domestic and international travel
• Significant and demonstrable working-knowledge of regulatory procedures and guidelines in all regions (global scope)
• Proven record in clinical study design, monitoring and execution and results analysis
• Has demonstrated knowledge of designing, implementing, and conducting clinical studies, to produce both timely and high-quality data.
• Proven record of working on teams and in a matrix environment.
• Proven ability to get results in a matrix management environment.

＜歓迎 / Preferred＞

• Training in a relevant subspecialty, such as vascular neurology, neurocritical care, or stereotactic and functional neurosurgery.
• Clinical research experience as a site investigator or sub-investigator on a clinical trial
• Ph.D., M.S., post-doctoral laboratory research experience, or equivalent scientific training
• At least one scientific or clinical publication
• At least one scientific or clinical presentation at a regional or national meeting
• Phase 1 clinical trial experience
• Experience working in gene therapy, RNA therapy, or stroke drug development
• U.S. F.D.A. Pre-IND, IND, and BLA submission experience
• E.U. E.M.A. CTA and MAA submission experience
• Proficiency with Medidata Rave and Veeva Vault
• Working knowledge of artificial intelligence system use (e.g., Microsoft CoPilot)
• Experience in development and implementation of global clinical trials for the registration and support of new molecular entities worldwide

【応募書類 / Application Documents】

和文履歴書・和文職務経歴書・英文レジュメ

Both Japanese and English Resumes are needed

【選考プロセス / Selection details】

書類選考 → 1次面接 → 最終面接

※変更の可能性もございますので、予めご了承下さい。

CV screening → First interview → Final interview

*Please be advised that there might be a change in the process.

【勤務地 / Location】

（雇入れ直後）

東京都中央区　アステラス製薬　日本橋事業所　本社

Nihonbashi, Tokyo

（変更の範囲）

会社の定める事業場および自宅

【勤務開始日 / Start Date】

応相談

Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration】

期間の定めなし

Not limited to specified period

【試用期間 / Probation Period】

試用期間原則なし

No probation period in principle

【給与 / Salary】

①当人の経歴・技術・技能等を考慮して決定

②中長期インセンティブ報酬:株式報酬

①Will be decided by the candidate's experience, skill and capability.

②Long-term incentive: Share Plan

【昇給 / Salary Raise】

有り

【賞与 / Bonus】

有り

【諸手当 / Allowance】

住宅手当、通勤手当　等

Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】

管理監督者　8:45～17:45（月～木）、8:45～16:00（金）

Managers and Supervisors　8:45～17:45（Mon～Thu）、8:45～16:00（Fri）

【休日 / Holidays】

完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave】

年次有給休暇、育児休業制度、介護休業制度　等

Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare】

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度　等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【アステラス製薬　採用サイト/ Career web site】

https://re-jp.astellas.com/jp/recruit/newgraduates/

For more information about Astellas, please visit our career web site.

"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."

【What awaits you at Astellas? 】

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

【Our Organizational Values and Behaviors】

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.