Medical Director, Medical Safety Evaluation - Jersey City, United States - Mitsubishi Tanabe Pharma

Description

Overview:

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japans most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), and amyotrophic lateral sclerosis (ALS).

MTPA is rapidly expanding its operations across all functional areas. MTPAs commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare diseases treatments including RADICAVA (edaravone) injectables in 2017, EXSERVAN (riluzole) oral film in 2021, and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

The Medical Director is responsible for leading Mitsubishi Tanabe Pharma America (MTPA) global product and/or combination product level safety analysis and strategic medical safety management 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 product portfolio. The Medical Director is accountable for providing medical input to the assessment of the safety profile for each global product and for appropriate and timely regulatory reporting of safety issues.

• Leads overall medical safety evaluation for assigned global products through the pharmaceutical product lifecycle management.
• Participates in US FDA and Health Authority safety interactions/responses as the product safety lead.
• Proactively identifies, investigates and manages global products (drug, combination product) safety risks and device-related safety risks ensuring timely communication with relevant stakeholders and senior management.
• Responsible for the development and implementation of innovative global product (including drug, combination product and device) risk management strategies.
• Utilizes technical combination product and device knowledge, regulatory expertise and lessons learned to shape MTPA and global best practices.
• 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
• Completes/reviews medical assessments of safety data [Periodic Safety Update Reports (PBRER, 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., 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), 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
• 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 Performs medical review/approval of medically coded safety data, including adverse events, medical history and concomitant medications.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.

• 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 10 years in the pharmaceutical industry experience with at least 8 years of experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions
• Solid understanding of scientific principles and regulatory requirements relevant to global drug and drug-device combination product development, registration and post-market support
• 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 PBRER, DSUR, RMP documents etc.
• Solid understanding of 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 10-15%

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, MTDA offers our employees outstanding opportunities for career success coupled with a supportive level of employee benefits:

Medical/Dental | Life Insurance | Supplemental Life Insurance/Dependent Life Insurance | Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employees Savings Plan (401K Plan) | Competitive Paid Time Off

The salary range for this position is $171,000 - $290,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.