Senior Director Clinical Development - Early Development Team Leader (Edtl)

Company Description

Entrepreneurial Verve, Rooted in Tradition. At MT Pharma America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma, 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.

Job Description

The Senior Director, Clinical

Development will fill a vital role in our growing organization serving as the Early

Development Team Leader (EDTL) responsible for overseeing a globally based, multidisciplinary

team responsible for successful delivery of development milestones including

IND, FIH, POC, EOP2 and NDA. In addition

to leading the Early Development Team (EDT), the individual will be responsible

for supporting the development and writing of regulatory documents (IB/IND/CTA),

study protocols and clinical development plans. The role will include oversight

of design and conduct of FIH and proof of concept studies for new molecules

that were discovered in Mitsubishi Tanabe Pharma Corporation (MTPC)

laboratories or obtained through in-license activities. Presently, the role will be responsible for

leading one or more projects with global teams including representatives from non-clinical,

clinical operations, CMC, project management

and regulatory affairs in

preclinical to Phase IIa (human proof of

concept). Therapeutic areas may vary and the pipeline candidates may be small

molecules or biologics covering broad disease markets all the way down to

narrow indications including orphan conditions.

Duties:

With respect to leadership of the

EDT, the responsibilities will vary based on the products' life cycles, but

will include the following:

• Responsibility

for the success of a project from pre-IND to POC

• Lead the EDT to plan, execute and

manage the early stage development projects

• Set expectations of deliverables to

functional representatives within the team

• Working closely with the EDT Project Manager, plan and

manage the project timelines, the project budget and the human resource

requirements against the approved IDP and approved resources.

• Represent the project at decision-making meetings

Additional responsibilities outside

the EDT include the following:

• Provide scientific expertise to New Product

Marketing Strategy

• Working closely with Marketing and Medical Affairs, define the publication

strategy

• Working closely with all

contributing lines of the organization, shepherd the development of an integrated

development plan

• Assist and manage a medical writer

for full protocol, regulatory documents or other deliverables.

• Communicate with KOLs as needed to

for development of target indications, clinical development plans, study designs

and program feasibility.

• Support clinical operations and regulatory

affairs staff as needed.

• Collaborate with internal staff

from multiple functions in Mitsubishi Tanabe Pharma Development America (MTDA)

(the US subsidiary of MTPC), consultants and CROs. Communicate with Europe and

Japan (MTPC).

Qualifications

Excellent communication skills, both

verbal and written

Minimum of 15 years of industry

experience (Pharmaceutical, Biotech or related field)

Minimum of 10 years of hands-on

experience: Developing a clinical development plan after deep understanding and

evaluation of nonclinical data, CMC, regulatory, marketing and clinical

operations;

Minimum of 5 years of hands-on

experience: leading a global team for clinical development including

non-clinical, clinical, data science, regulatory and CMC staff; and

communicating with FDA and/or EMA

Designing/writing phase 1 and 2 clinical

study protocols, and comfortable with supporting the writing of sections from IB/IND/CTA

or other regulatory dossiers as needed;

Preferred: Experience filing NDA(s); experience creating clinical

development plan in immunology, dermatology, internal medicine or neurology

areas including orphan conditions

Additional Information

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, MT Pharma America offers our employees unparalleled 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