Director - Translational Strategy job in Gaithersburg, USA

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Last Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Biological Sciences, Medicinal Chemistry

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Director - Translational Strategy for a global pharmaceutical company located in Gaithersburg, MD.

Must be eligible to work in the US.

Job Responsibilities:

Develop and implement biomarker testing strategies as part of clinical trials, with contributions to the design of clinical study protocols and go/no-go decision-making for molecules in the V&I portfolio.
Effectively lead in a cross-functional matrix environment, relying on outstanding organizational skills with attention to detail and outstanding communication skills.
Work collaboratively to ensure scientific excellence and robust delivery of translational endpoints for multiple clinical-ready programs.
Work cross-functionally to generate, analyze, and integrate pharmacodynamic, immunogenicity, serology, neutralizing antibody, and viral/bacterial sequencing data from clinical trials and external collaborations.
Coordinate global surveillance studies with academic and non-government organizations; design and implement studies to monitor resistance.
Provide scientific and technical support for regulatory communications and filings.
Knowledge of good clinical practices (GCPs) and good laboratory practices (GLPs); familiar with ICH guidelines for assay validation and implementation.

Skills and Requirements:

PhD in Virology, Bacteriology, Immunology, Molecular Biology, Microbiology, Cell Biology, or other relevant scientific fields
A minimum of 7-10 years post-PhD experience, preferably in a biopharma/biotech setting.
A record of innovative contributions to translational research, as evidenced by a strong publication record, inventorship on patents/filings and presentations at major conferences.
Demonstrated ability to influence and build positive relationships with highly regarded Key External Experts
Advanced problem solving, risk management, and influencing skills.
Successful strategic planning and organizational skills working in a matrix environment; consistent history empowering and developing others.

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at +(1) 646-367-2764 or s.amark@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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INDSCIC

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Highly Competitive Salary

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Wrexham, Wales

Proclinical is seeking a Senior Principal Scientist to lead strategic projects in biomanufacturing processes, focusing on API/Drug substance processing.