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, ClinicalDevelopment will fill a vital role in our growing organization serving as the EarlyDevelopment Team Leader (EDTL) responsible for overseeing a globally based, multidisciplinaryteam responsible for successful delivery of development milestones includingIND, FIH, POC, EOP2 and NDA. In additionto leading the Early Development Team (EDT), the individual will be responsiblefor supporting the development and writing of regulatory documents (IB/IND/CTA),study protocols and clinical development plans. The role will include oversightof design and conduct of FIH and proof of concept studies for new moleculesthat were discovered in Mitsubishi Tanabe Pharma Corporation (MTPC)laboratories or obtained through in-license activities. Presently, the role will be responsible forleading one or more projects with global teams including representatives from non-clinical,clinical operations, CMC, project managementand regulatory affairs inpreclinical to Phase IIa (human proof ofconcept). Therapeutic areas may vary and the pipeline candidates may be smallmolecules or biologics covering broad disease markets all the way down tonarrow indications including orphan conditions. Duties: With respect to leadership of theEDT, the responsibilities will vary based on the products' life cycles, butwill include the following:Responsibilityfor the success of a project from pre-IND to POCLead the EDT to plan, execute andmanage the early stage development projects Set expectations of deliverables tofunctional representatives within the teamWorking closely with the EDT Project Manager, plan andmanage the project timelines, the project budget and the human resourcerequirements against the approved IDP and approved resources.Represent the project at decision-making meetingsAdditional responsibilities outsidethe EDT include the following:Provide scientific expertise to New ProductMarketing StrategyWorking closely with Marketing and Medical Affairs, define the publicationstrategy Working closely with allcontributing lines of the organization, shepherd the development of an integrateddevelopment plan Assist and manage a medical writerfor full protocol, regulatory documents or other deliverables.Communicate with KOLs as needed tofor development of target indications, clinical development plans, study designsand program feasibility. Support clinical operations and regulatoryaffairs staff as needed.• Collaborate with internal stafffrom multiple functions in Mitsubishi Tanabe Pharma Development America (MTDA)(the US subsidiary of MTPC), consultants and CROs. Communicate with Europe andJapan (MTPC).Qualifications: Excellent communication skills, bothverbal and writtenMinimum of 15 years of industryexperience (Pharmaceutical, Biotech or related field) Minimum of 10 years of hands-onexperience: Developing a clinical development plan after deep understanding andevaluation of nonclinical data, CMC, regulatory, marketing and clinicaloperations;Minimum of 5 years of hands-onexperience: leading a global team for clinical development includingnon-clinical, clinical, data science, regulatory and CMC staff; andcommunicating with FDA and/or EMA Designing/writing phase 1 and 2 clinicalstudy protocols, and comfortable with supporting the writing of sections from IB/IND/CTAor other regulatory dossiers as needed; Preferred: Experience filing NDA(s); experience creating clinicaldevelopment plan in immunology, dermatology, internal medicine or neurologyareas 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