Job Abstract

Job ID

2024-1862

# of Openings

1

Category

Medical Science & Translational Research

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 Japan’s 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. MTPA’s 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 Senior Director, Clinical Pharmacology supports the company’s Clinical Development teams, brings expertise in oversight of Clinical Pharmacology, and integrates characteristics of ADME of the drug, pharmacometrics, and non-clinical data (ADME, toxicology) to assist in the development of the clinical pharmacology aspects of compounds from multiple therapeutic areas. The Senior Director, Clinical Pharmacology works to advance multiple compounds by integrating PK/PD and clinical data to evaluate/simulate optimal doses/regimens, exposure-response, exposure-safety analyses, etc. to support the clinical pharmacology section of product inserts. The incumbent designs and writes clinical PK protocol synopses, PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions. The Senior Director, Clinical Pharmacology also analyzes, interprets and integrates all available clinical data to refine the PK development plan, and actively participates in cross-functional and clinical teams by promoting clinical pharmacology, explaining/defending the PK strategy and data analyses, and providing PK deliverables according to timelines.

The Senior Director, Clinical Pharmacology role represents an outstanding opportunity to use and share your experience and pharmaceutical development knowledge in the areas of neurology and inflammation while growing your skill set in a fast-paced learning environment that includes many rare diseases.

• Provides clinical pharmacology and pharmacokinetic expertise through the designs and implementation of clinical pharmacology development plans; study design/protocol development, PK/PD analyses and data interpretation, and defining study conclusions.
• Supports the successful delivery of early- and late-stage clinical milestones for the Company, drawing on expertise in clinical and regulatory requirements, both U.S. and international, related to clinical medicine and drug development processes.
• Develops Clinical Pharmacology studies protocol using up-to-date scientific information and innovative methodologies to maximize the accuracy and effectiveness of the clinical studies.
• Supports the goal of meeting Company objectives leading to quality submissions to various worldwide regulatory agencies.
• Assists in evaluation and interpretation of clinical pharmacology data to prepare for internal governance bodies and regulatory interaction; integration of clinical pharmacology study results, drafting and refining the clinical pharmacology contents of drug labels.
• Provides clinical pharmacology inputs in dose selection for Phase II/III studies and modeling/simulation of emerging PK/PD data.
• Stays abreast of recent developments in the field of clinical pharmacology and relays that information to staff in both formal and informal meetings.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Actively engages and works with other members of the clinical trials to enhance and advance the Clinical Pharmacology concepts; interacts and educates team members on the PK/PD aspects of the projects.
• May be requested to conduct other project-related tasks under the company’s drug development management structure and applicable FDA/ICH guidelines and regulations.

• PhD degree in pharmacokinetics or related discipline
• A minimum of 15 years of clinical pharmacology/pharmacokinetic drug development and data analysis experience demonstrated through progressively responsible scientific roles.
• Managerial position in Clinical Pharmacology is a plus.
• Experience formally communicating with regulatory agencies, including FDA and EMA (e.g., attendance at meetings with RAs; writing Clinical Pharmacology briefing book sections; drafting Response to Questions from RAs during filings)
• Experience collaborating or communicating with external service providers and suppliers directly involved in the drug development process.
• Thorough understanding of early- and late-stage clinical programs in Clinical Pharmacology, including hands-on experience and skills in utilization of modeling and simulation in drug development
• Strong knowledge of related FDA and ICH regulations
• Proven ability to analyze, interpret and integrate all available clinical data, including ability to assess results from standard PK software (e.g., WinNonlin, NONMEM), although proficiency in the use of such programs is not required.
• Strong technical writing skills
• Demonstrated ability to work effectively with people, lead teams, and explain/defend analyses and plans.
• A consultative style with proven ability to transfer knowledge at all levels of the organization.
• Required to travel up to 20% as needed, though travel is expected to be infrequent

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 | Employee’s Savings Plan (401K Plan) | Competitive Paid Time Off

The salary range for this position is $194,000 - $329,000. 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.