Senior Director Clinical Development – Early Development Team Leader (EDTL)

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).

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

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