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Posted: Wednesday, February 7, 2018 12:07 AM

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Klein Hersh International - Redwood City, CA

The Head of Translational Medicine will be responsible for advancing the science of early development, bridging across research, preclinical and early development functions to define initial biochemical activity in first clinical indications.

S/he will be responsible for designing and implementing a strategy for optimal integration of early clinical development and for defining the paths toward clinical Proof of Concept (PoC).

Job Responsibilities

Provide clinical perspectives to preclinical sciences, develop target product profiles for preclinical programs, strategically guide IND-enabling preclinical studies that will support clinical plans.

Design early phase studies

Relate science/mechanisms of action to expected clinical profile in fibrotic disease

Select, validate and develop clinical biomarkers to demonstrate proof of mechanism, support dose selection and understand PK/PD relationship.

Participate in defining criteria for medical needs and in new target selection.

Partner with others on the development, implementation and growth of our companies patient registry and leveraging its use for patient stratification and trial design.

Collaborate with and, where appropriate, oversee consultants and third party service providers supporting the Translational Medicine program.

Work with senior leadership to help represent the company as a senior translational/medical spokesperson before appropriate scientific, medical, regulatory, business and other professional meetings.

Serve as translational medicine representative to Business Development efforts in the evaluation and implementation of partnerships, joint ventures, and in-/out-licensing opportunities.

Job Requirements

M.D. is required, M.D. / Ph.D. degree is preferred.

5-10 years’ industry experience, preferably in fibrotic disease.

Strong track record in translational medicine including hands-on experience taking small molecules and/or biologics through preclinical development into the clinic.

Knowledge of fibrotic disease pathways and their relevance to the clinic.

Direct experience and/or training in Fibrotic Disease preferred; additional experience in other therapeutic areas will be a plus.

Knowledge of applied research sufficient to understand how translational science enables the evolution into Clinical Development.

Working knowledge of genetic/genomic and/bioinformatics technologies and their application in translational approaches, especially in fibrotic disease is preferred.

Ability to collaborate with internal and external multi-disciplinary research and development teams.

Experience with PK/PD analysis and modeling

Experience developing novel approaches to clinical development in partnership with the FDA will be a plus.

Ability to oversee collaborations with CROs and academic centers.

Extensive contacts and well-developed relationships within the academic scientific community and regulatory agency.

Exceptional analytical and problem-solving abilities.

Experience with the regulatory environment.

Understanding of clinical evidence base and active research behind the use of molecular markers in treatment selection

Excellent written and verbal communication capabilities.

Location(s) Redwood City, CA

If interested, please send a MS Word version of your resume to eschwartz@kleinhersh.com


• Location: San Mateo

• Post ID: 92273622 sanmateo
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