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Head of medical and clinical affairs

CRADLE GENOMICS

This is a Full-time position in San Diego, CA posted December 17, 2019.

Cradle Genomics is currently seeking a Head of Medical and Clinical Affairs, with experience in establishing strategic medical partnerships, clinical trial design and management, and regulatory submissions. Responsibilities:Define and implement clinical trial and publication strategy for CLIA lab operationsDevelop and maintain Clinical Affairs policies, procedures and documentationPartner with Development, Lab Operations and Marketing in the design of clinical trials including protocol development, timelines and budgetManage clinical study sites: monitoring recruiting and screening activities to ensure timely enrollmentDeliver high quality trial datasets enabling peer-reviewed publications on time and to budgetEnsure publications and regulatory submissions are of exceptional quality and aligned to local standardsIdentify potential compliance deficiencies and communicate same to executive management for corrective actionLiaison with and management of CROs and other outside consultants as requiredManage communication and interactions with medical societies and professionalsEstablish a medical science liaison team and ensure consistent and accurate medical communicationsProvide medical input in the development of the company’s strategic plan, budgets, medical information, marketing and training materialsServe as a clinical and context expert for both internal stakeholders and in representing the company to external audiencesDirect the organization’s Medical Advisory Board and medical KOL engagementAttend medical/scientific meetings as necessary, including both domestic and international travel Qualifications and Experience:Physician leader (MD or equivalent) requiredSpecialization in ObGyn and/or genomics preferredPhD desirableAt least 5 years industry experience with a strong management background and proven leadership skillsSolid working knowledge of genomics and clinical use of next-generation sequencingExperience working in the non-invasive prenatal testing market preferredExcellent oral and written communication skillsAbility to work effectively within a team, cross-functionally, and as an independent contributorProficiency with the FDA, CFDA and/or EMA regulations is desirableExperience in the field of prenatal health and non-invasive prenatal testing is desirable