Medical Director, Medical Safety Evaluation

Overview Entrepreneurial Spirit, Rooted in Tradition.

At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making.

Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

Relatively new to the U.S.

market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S.

partners.

In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label.

We’re currently building a new commercial organization and expanding our other functions to support this strategy.

The Medical Director, Medical Safety Evaluation (MSE) is responsible for leading product level safety analysis and strategic medical safety management for global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC).

Incumbent implements corporate policies to ensure the safety of the product in global development portfolio.

The Medical Director is accountable for providing medical input to the assessment of the safety profile for each drug and for appropriate and timely regulatory reporting of safety issues.

Responsibilities Leads overall medical safety evaluation for assigned global investigational products and clinical development program.

Participates in FDA or other health authority safety interactions/responses as the product safety lead.

Has full accountability for all aspects of the global drug safety function, including development/delivery of a quality Pharmacovigilance system for assigned products/activities.

Is the primary safety representative between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, external experts, and CROs) on product safety related issues.

Leads safety signal detection activities and chairs global cross functional safety teams, with appropriate communication/escalation.

Oversees/conducts signal tracking for products according to regulatory requirements and corporate business strategy.

Completes/reviews medical assessments of safety data [Periodic Safety Update Reports (PSURs, DSUR), safety sections for labels/IBs/regulatory submissions (e.g.

IND/pre-NDA briefing books, safety queries), Safety Surveillance Plans, and CCDS] as appropriate and ensures the benefit/risk information is accurate.

Oversees development and preparation of Risk Management Plans (RMPs), safety portions (e.g., 2.7.4, ISS), and 120-day safety updates for regulatory approval filings.

Interacts extensively with regional and corporate departments to provide medical/drug safety strategic input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing.

Works with cross-functional commercial teams to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities.

Oversees data collection, processing, assessment, and preparation of case reports, annual reports, and periodic reports to ensure the timely submission to international regulatory agencies as well as ensure quality medical assessment (e,g., case medical review oversight).

Provides overview of the safety aspects of the planning, execution, data collection and interpretation of clinical research.

Performs medical review/approval of medically coded safety data, including adverse events, medical history and concomitant medications.

Accountable for the performance and results of the Drug Safety department and provides medical advice, training, and support.

Implements department plans and priorities to address business and operational challenges.

Develops and implements strategies for Pharmacovigilance business plans in accordance with long-term company strategic plans.

This includes active involvement and coordination with local and international Pharmacovigilance directors and physicians.

Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements.

Improves organizational efficiency through outsourcing and other alliances.

Provides input to senior management, as requested, regarding safety aspects of brand strategy, key messages, data review, and future data needs.

Performs other departmental duties as assigned.

Qualifications Medical Degree (MD or DO); current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience desired Post-graduate training in clinical epidemiology and biostatistics is also desirable Minimum of 8 years in the pharmaceutical industry with at least 5 years of experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions Previous experience with leading strategic safety medical evaluation activities (e.g., Medical Director/Global Safety Officer level) at a product level is required Experience writing/leading pharmaceutical regulatory or clinical research safety documents, including periodic safety reports, IB safety sections, and risk management plans required Experience as lead safety physician for Phase I-III trials, especially with key safety activities (e.g.

SMMP, CRO interaction, AOSE, IND update, AR, ISS) required Experience with safety databases, including medical review of case reports (pre-marketed and post-marketed products) required Contributor for PSUR, RMP, and DSUR documents Experience as lead safety physician in post-marketing/phase IV studies and surveys with key activities (e.g.

patient registries, survey protocols) preferred Familiarity with US and International Safety reporting regulations and guidelines (in particular, ICH clinical safety guidelines) Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Required to travel domestically and internationally typically up to 10%