EXECUTIVE DIRECTOR, DATA SCIENCE & MEDICAL WRITING

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 Executive Director, Data Management and Medical Writing is a leadership role responsible for overseeing the Data Science and Medical Writing organization, and for the development and ongoing operation of the company's tools, technologies, and technical solutions leveraging data science, advanced analytics, machine learning and other algorithms to support clinical development activities.

The Executive Director, Data Management and Medical Writing draws on industry expertise to serve as a key contributor to strategic planning.

This is realized through membership on the Global Clinical Development Leadership Team.

Responsibilities :

• Acts as global lead for the development and execution of biostatistics, statistical programming, and data management strategies to support clinical development activities.
• Oversees statistical leadership into the ongoing clinical trial programs and for development of new programs.
• Provides input into drug development strategies along with Program level and Group level personnel.
• Supports interactions with global health authorities, as well as with partner contract research organizations.
• Ensures quality and timeliness of statistical, programming and data management deliverables.
• Responsible for the attestations of data integrity of clinical trials and accuracy of all statistical analyses across all development programs.
• Accountable for the accuracy of statistical proposals that are part of materials for health authority meetings.
• Provides resources and supports analytical activities that are included in plans for scientific publications with the publication and medical affairs teams.
• Contributes to shaping company strategy as a member of the Global Clinical Development Leadership team.
• Manages the data science team and medical writing team. Ensures high quality management, engagement, and motivation of employees in the teams, and provides necessary resources to the Data Science and Medical Writers team with ongoing assessment of capability needs.
• Mentors and develops members of the Data Science and Medical Writing organization.
• Establishes and ensures adherence to biostatistics and statistical programming best practices, SOPs, standards, and processes regarding the conduct of clinical trials, statistical methodology, data analyses and interpretation.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.

Qualifications :

• A Doctoral degree in Statistics is required.
• Minimum of 15 years in biotech and / or pharmaceutical industry in roles of increasing responsibilities related to biostatistics and data management.
• Previous experience in managing multiple direct reports is a must, preferably with direct responsibility for areas not limited to biostatistics.
• Experience with multiple (s)NDAs, BLAs, and MAA's is a must, and experience with J-NDA submissions and reviews is preferred.
• Ideally, has worked in more than one therapeutic area and has direct experience with innovative Phase ll clinical study designs with the therapeutic areas of interest residing in rare or uncommon disorders encompassing the development of small and large and biological molecules.
• Experience collaborating with or overseeing the work of external service providers or suppliers in the drug development process.
• Experience presenting complex information to senior executives is a plus.
• Demonstrated record of fostering creativity, productivity, and execution with urgency, teamwork, and accountability.
• Team-builder who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives.
• Comfort level with model-based drug development and agile drug development is important.
• Appreciation for observational methodologies is preferred.
• Ability to clearly articulate complex methodologies to senior executives.
• Required to travel up to 20% both domestically and internationally.

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, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

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.

The salary range for this position is $242,000 - $412,000. 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.