Assistant (or Associate) Medical Director, Oncology Japan Development

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . onTwitter ,Facebook ,Instagram ,YouTube andLinkedIn .

Job Description

Purpose Statement:

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

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:

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

1-1 Medical inputs into clinical development plan

• Provide medical knowleages during preparation of clinical development strategy plans.
• Contribute to interaction with PMDA and key opinion leaders (KOLs) by providing medical and scientific perspectives.

1-2 Medical inputs in execution of clinical study

• Provide Japanese medical information such as epidemiology data, standard of care, and /or guideline during protocol development
• Provide medical suggestions or inputs regarding safety issues and contribute implementation of global study.

1-3 Tasks related to NDA and other activities

• Review Japanese CTD (CSE, CSS) and confirm if the contents are medically appropriate.
• Contribute preparations of query response for PMDA by providing medical knowledge
• Attend a meeting led by medical department such as a advisory board meeting prior a drug

approval

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

• 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 is responsible for discussion with PMDA and KOLs
• TA MD is responsible for the contentes of CSR

Qualifications

Qualifications:

• Sufficient and medical knowledge in the therapeutic area assigned
• General knowledge of pharmaceutical association (Seiyaku kyo and Pharma etc.).
• TOEIC score is 800 or higher, or equivalent skill for English communication.
• Experience of participating in company-sponsored clinical studies as investigators
• At least 5 year experience of medical practice (Associate Professor or equivalent is preferable)
• Having experience in clinical development would be preferable.
• Graduate from Medical School (PhD degree holder is preferable)
• Qualified Medical Doctor (mandatory)

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.

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.