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Vice President, Non-Clinical Development - Austin

Company: Molecular Templates
Location: Austin
Posted on: July 16, 2019

Job Description:

Company Description:Molecular Templates (MTEM) is a clinical stage biopharmaceutical company targeting a variety of cancers through development of its innovative proprietary Engineered Toxin Body (ETB) platform. MTEM's first immunotoxin, MT-3724, is in clinical development for non-Hodgkin's lymphoma. Pipeline products for additional oncology targets are being advanced toward clinical development. For more information, please visit MTEM's website at www.mtem.com. Position Overview:Molecular Templates is seeking an experienced and dynamic professional who will play a vital role in advancing Molecular Template's nonclinical programs, driving the support all nonclinical toxicology, PK and PD efforts for our in-house products from IND-enabling through clinical development phases. As a key member of the management, this role will lead nonclinical development efforts across our pipeline, from study design to execution and support of regulatory filings. This requires excellent technical knowledge, ability to provide strong leadership in order to drive results and meet corporate goals and timelines and ability to work in a fast-paced, high-growth environment.Job Responsibilities will include: In coordination with the Chief Development Sciences Officer, devise strategy for, develop and implement preclinical/nonclinical studies for investigational medicines, assuming accountability for design and execution of studies and analysis. Work closely with other functional areas with both in-house and contract R&D (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to support the execution of programs and clinical trials. Direct all clinical and nonclinical product specific assays such as PK and ADA bioanalytical methods and IVDs, along with the PK/PD data analysis and reports. Incorporate regulatory strategy and data from competitive intelligence into clinical trials, in conjunction with project team members, regulatory affairs and senior management. Provide scientific input during the development, execution and completion of clinical trials. Interpret clinical trial PK/PD data and nonclinical date to prepare reports, regulatory submissions and publications based on the results. Qualifications: PhD in Life Sciences Experience in oncology, immunology, toxicology or DMPK, required. Minimum ten (10) years of drug development in biotech and/or pharmaceutical environment. Proven experience and success with development of oncology or immunology assets. Demonstrated experience in preparation of document submission and acceptance to regulatory agencies; IND, required and EOP2/BLA/MA, preferred. Strong knowledge of ICH, GxP, and FDA, and international regulatory requirements. Excellent written and verbal English communication skills and proven ability to work in a collaborative environment, working with internal and external stakeholders. Experience in leading the design, conduct, analysis and reporting of nonclinical studies. Excellent organizational and time management skills, ability to lead and manage multiple complex projects. Ability to provide thought-leadership and drive results leading to success of corporate goals and timelines. Ability to work in a fast-paced, high-growth environment. Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships. Ability to work proactively and effectively using creative problem-solving skills. Travel required, 10-20%. Reporting Structure:This position currently has supervisory responsibilities. This position reports to Chief Development Sciences Officer.Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.Molecular Templates Inc https://mtem.isolvedhire.com

Keywords: Molecular Templates, Austin , Vice President, Non-Clinical Development - Austin, Healthcare , Austin, Texas

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