Director, Clinical Science - 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 Director, Clinical Science (I&I) will lead the early- to late-stage development team(s) in designing, planning, implementing and executing clinical development plans and programs in accordance with company processes, SOPs, and FDA/ICH guidelines and regulations. As a senior clinical development team member, the incumbent will lead the successful delivery of milestones for assigned project(s), such as IND, EOP2, NDA and MAA for the company, drawing on expertise in clinical and regulatory strategy and requirements, both local and international, related to the clinical medicine and drug development processes. The Director, I&I will lead multidisciplinary teams, mentoring and motivating individual team members to meet overall corporate objectives. Specific targeted conditions within the I&I therapeutic area may vary based on priorities of the current pipeline; however, experience with rare diseases associated with immunology, inflammation, and/or dermatology disorders is desired.

Overall responsibilities will include clinical development strategy, clinical program oversight, and oversight of clinical interactions with regulatory agencies within the I&I therapeutic area. This may include leading the design, implementation, monitoring, analysis, and reporting of clinical studies for I&I programs. The Director, Clinical Science (I&I) will also lead/participate in developing the long-range strategic plans and commercial planning of I&I indications.

• Works closely with the Senior Director, Immunology & Inflammation (I&I) in translating the companys long-term vision into a development strategy in I&I.
• Delivers sound clinical development plans of I&I programs according to the strategy and direction set by the companys senior leadership.
• Advises and provides guidance to the I&I research and clinical programs from a medical point of view.
• Serves as the project leader in I&I development programs.
• Guides and mentors other project leaders in the I&I therapeutic area.
• Works closely with the relevant development team Project Managers; plans and manages the responsible project timelines, the project budget and the human resource requirements against the governance approved development plan and resources.
• Represents project(s) at senior management and governance stage-gate approval meetings.
• Oversees the critical design and analytical aspects of I&I clinical development plans, protocols and statistical analysis plans (SAPs).
• Oversees the strategy and support of operational aspects of I&I clinical trial execution, data management and data analysis in partnership with Global program and project leaders from various functional lines.
• Leads clinical/scientific expertise for development of effective commercial and marketing strategy for I&I projects.
• Works closely with Medical Affairs and KOLs to define the publication strategy of I&I projects.
• Serves as a Subject Matter Expert of important clinical and regulatory submissions supporting I&I clinical programs for all stages of development.
• Collaborates with KOLs, as needed, on clinical/regulatory strategy, Health Authority Advisory meetings, development of target indications, clinical development plans, study designs and program feasibility.
• Leads program specific team meetings/presentations with senior management in US, EU and Japan as needed.
• Evaluates, interprets, and presents complex scientific clinical data as required for senior management on a global basis.
• Supports regulatory safety reporting for clinical programs as needed: SAE assessment, queries and follow-up, annual reports and investigator brochures.
• Supports relevant due diligence of new in-licensing opportunities, research programs and technologies as needed.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Performs other duties as required.

• Advanced Degree in Life Sciences - PhD is required (MD or MD/PhD preferred).
• Minimum of 8 years of industry experience (Pharmaceutical, Biotech, or related field) with a minimum of 5 years in Clinical Development. Experience was preferably gained in large pharmaceutical companies and included a strong background in Immunology, Dermatology, and Rare/Orphan Disease clinical development.
• Hands-on experience in leading large, global cross-functional teams for product development with evidence of success for obtaining EOP2 and/or MAA/NDA.
• Experience with both early- and late-stage clinical development. Strong scientific background with a good understanding of drug discovery process and preclinical research.
• Experience with HEOR (Health Economic Outcomes Research), PRO (Patient Reported Outcome) Measures is preferred.
• High level of expertise in drug development including traditional New Drug Application (NDA), Biologics License Application (BLA), fast track, accelerated approval and breakthrough therapy.
• Superior interpersonal skills coupled with multicultural awareness. Able to successfully establish relationships, communicate effectively within/across company disciplines, and thrive within a global, highly matrixed, organization.
• Good leadership, management, mentoring and motivational skills; able to marshal cross-functional teams to achieve goals.
• Ability to work seamlessly with external partners in the drug development process including KOLs, external service providers and suppliers.
• Well-honed project management skills. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
• Attention to detail and commitment to high-quality and on-time deliverables.
• A highly analytical and scientific mind coupled with business acumen; thinks both strategically and tactically.
• Required to travel up to 20% 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, 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 $155,000 - $264,000. 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.