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Vice President, Head of Translational Medicine and Early Development

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Vice President, Head of Translational Medicine and Early Development Company: Sumitomo Dainippon Pharma Oncology, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

National Postdoctoral Association Career Center Vice President,Head of Translational Medicine and Early Development

Vice President, Head of Translational Medicine and EarlyDevelopment Cambridge, Massachusetts, United States

9 days ago

Description

The Head of Translational Medicine and Early Development willdevelop and execute translation medicine and early developmentstrategy to effectively bridge preclinical and early clinicalphases to improve overall success/speed of portfolio assets.

Responsibilities

Develop, implement and manage the Company’s translationalMedicine & Early Development strategy In collaboration withinternal and external R&D partners, lead the TranslationalMedicine effort of BBI’s oncology compounds from pre-IND studiesthe proof-of-concept (PoC) phase.

Responsible for the integrated development plan (IDP) throughPoC in partnership with other functional areas. This includesassessment of medical need, proposal of clinical developmentpathways, and review of preclinical data for clinical implications,acquisition of clinical samples and other relevant activities.

In close collaboration with research scientists (internal andexternal), identify, develop, and implement strategy forpreclinical support of program-related objectives.

Develops the First in Human (FIH) and POC strategy includingprojects and, for example: makes recommendations regardingendpoints, design, safety evaluations and initial doseselections.

Lead global project teams through PoC phase to driveimplementation of the PoC strategy by providing medical andscientific leadership and expertise to all line functions on theproject team.

Accountable for compound related biomarker strategies; worksclosely with Biomarker experts in implementation. Guide teams toalign preclinical and clinical biomarker strategies.

Contribute to evaluation of clinical centers and fostercommunication with crucial collaborating investigators incollaboration with Clinical Operations.

Responsible for implementation of additional supporting studiesduring the research and PoC phases, which may include methodologystudies to identify and validate novel endpoints for early decisionmaking in PoC studies and identify endpoints by which patientpopulations can be stratified to optimize chances of detectingsigns of activity of candidate molecules in early clinicalstudies.

Participates in analysis of study results and presentsconclusions to relevant decision boards.

Assures overall quality of appropriate aspects of Clinical Plan,Study Synopses, Study Protocols, and Clinical Trial Reports (CTRs)and Summaries (e.g. slide format and executive summaries).

Participate in team presentations to health authoritiesincluding IND, and Clinical Trial Authorization (CTA) IB, annualsafety report, etc.

Acts as the primary Company representative to Health Authorities(HA) and invite appropriate experts (internal and external)together with focus on early development.

Facilitate the establishment and maintenance of effectivecollaborations with academic institutions and patientfoundations.

Develop and manage yearly budget for the department and ensureappropriate alignment to agreed portfolio. Participate andrepresent area of expertise in the Company’s Mid-term BusinessPlanning process.

Liaise effectively with parent company and other internalstakeholder groups/personnel to advance the Company’s R&Dpipeline and promote a highly collaborative operating culture.

Perform other duties as directed.

Qualifications

MD or MD/PhD with at least 10 -15 years progressive experiencein oncology translational medicine/biology, pharmacology ordirectly related discipline, preferably in thebiopharmaceutical/biotech industry.

Highly developed mastery of the planning, control and monitoringof complex and highly visible drug development projects andactivities with a minimum of ten years- experience in pharmacologyand translational medicine within the pharmaceutical industry.

Demonstrated scientific and business acumen and the ability toinfluence senior leaders and stakeholders and lead complexpartnership and alliance activities.

Record of successful support of multiple, complex, globaltranslational medicine clinical projects and relateddeliverables.

Ability to provide motivational leadership to the organizationand improve its performance through the adoption of novelapproaches to advancement of clinical assets.

Broad knowledge of oncology and experience is highlydesirable.

Proven record of scientific achievement as evidenced bypresentations and publications in peer reviewed journals.

Excellent scientific knowledge in Translational Medicine,Pharmacogenetics and Clinical Pharmacology within the oncologyfield.

Position requires approximately 10% travel.

Please send resumes totalentacquisition@bostonbiomedical.com

Equal Opportunity Employer

California residents, please visitwww.bostonbiomedical.com/CAprivacynotice for information on ourprivacy practices.

Job Information

Job ID: 53749249

Location:

Cambridge, Massachusetts, United States

Position Title: Vice President, Head of Translational Medicineand Early Development

Job Function: Other / Not Listed

Job Type: Full-Time

View your connections at Sumitomo Dainippon Pharma Oncology,Inc. LinkedIn Sumitomo Dainippon Pharma Oncology, Inc. is adeveloper of novel cancer therapeutics based in the U.S. and awholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. ThisU.S. entity, together with the oncology research and developmentteams in Japan, DSP Cancer Institute and Oncology ClinicalDevelopment Unit, will collectively be known as Sumitomo DainipponPharma Oncology or SDP Oncology. SDP Oncology is relentlesslycommitted to advancing purposeful science by transforming newdiscoveries into meaningful trea...

View Full Profile

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Keywords: Amazon Workforce Staffing, Cambridge , Vice President, Head of Translational Medicine and Early Development, Other , Cambridge, Massachusetts

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