Job Title: Molecular Oncology Specialist
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About the Role
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We are seeking a highly skilled Molecular Oncology Specialist to lead clinical development activities for novel diagnostic solutions in Chronic Liver Diseases. The successful candidate will be responsible for planning and implementing clinical development strategies, leveraging expertise to review study results and protocol generation.
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Key Responsibilities:
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* Leverage expertise to lead critical reviews of study results, protocol, and report generation to support new product development.
* Collaborate with cross-functional teams to ensure appropriate implementation of clinical development strategies.
* Maintain clinical, regulatory, and scientific expertise related to IVD product development and regulatory documentation.
* Lead medical/scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies.
* Conduct comprehensive literature reviews, supervise collation of relevant clinical and scientific information from different sources, and create new scientific content.
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Requirements
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* Advanced degree in Life Science (PhD, PharmD, or equivalent degree) or a Medical degree with relevant expertise in the Healthcare Industry and/or academic institutions.
* ~3+ years of experience in academic, diagnostics, or pharma industry, preferably with experience in IVD or Medical Device development, development of study protocol design, report writing, and leading matrixed teams.
* Good knowledge of applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, FDA, NMPA regulations).
* Ability to travel up to 10-15% (can vary per project phase and position).
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What We Offer
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A challenging role in a dynamic environment with opportunities for professional growth and development. Our team is passionate about delivering innovative solutions that improve patient outcomes.
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Please note that this job description is subject to change based on business needs and requirements.
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