Tanabe Pharma America

Senior Director Clinical Development - Early Development Team Leader

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeJersey City, NJ, USANo salary listedIn-person

About the Job

Requirements

Excellent verbal and written communication skills.
A minimum of 15 years of industry experience in pharmaceuticals, biotechnology, or a related field.
A minimum of 10 years of hands-on experience developing clinical development plans after understanding and evaluating nonclinical data, chemistry, manufacturing and controls, regulatory, marketing, and clinical operations.
A minimum of 5 years of hands-on experience leading a global clinical development team that includes nonclinical, clinical, data science, regulatory, and chemistry, manufacturing and controls staff, and communicating with the U.S. Food and Drug Administration and/or the European Medicines Agency.
Experience designing and writing Phase 1 and Phase 2 clinical study protocols, and comfort supporting the writing of sections of investigator brochures, investigational new drug applications, clinical trial applications, or other regulatory dossiers as needed.

Responsibilities

Oversee an early development team responsible for delivering development milestones, including investigational new drug application, first-in-human, proof-of-concept, end-of-Phase-2, and new drug application milestones.
Support the development and writing of regulatory documents, study protocols, and clinical development plans.
Oversee the design and conduct of first-in-human and proof-of-concept studies for new molecules discovered in company laboratories or obtained through in-licensing.
Lead one or more projects with global teams spanning preclinical development through Phase IIa human proof of concept.
Take responsibility for project success from pre-investigational new drug application through proof of concept.
Lead the early development team in planning, executing, and managing early-stage development projects.
Set deliverable expectations for functional representatives on the team.
Work with the early development team project manager to plan and manage project timelines, budgets, and human-resource requirements against the approved integrated development plan and resources.
Represent the project at decision-making meetings.
Provide scientific expertise to new product marketing strategy.
Work with Marketing and Medical Affairs to define publication strategy.
Work across contributing organizational functions to develop an integrated development plan.
Assist and manage a medical writer preparing full protocols, regulatory documents, or other deliverables.
Communicate with key opinion leaders as needed to develop 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, consultants, and contract research organizations, and communicate with colleagues in Europe and Japan.

Desired Qualifications

Experience filing new drug applications.
Experience creating clinical development plans in immunology, dermatology, internal medicine, or neurology, including orphan conditions.

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 PhaseIIa (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 Marketingand 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:

About the Company

Tanabe Pharma America

Company size: Not listed
Company stage: Not listed
Total funding: Not listed
Headquarters: Not listed
Founded: Not listed

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