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Senior Clinical Scientist/Associate Director of Clinical Sciences

Cambridge, Massachusetts 02139

Post Date: 05/18/2018 Job ID: 1884 Job Category: Clinical: Scientific

Our client is seeking a talented and passionate individual to join our dynamic clinical team. In this role, you will be responsible for providing scientific support for clinical development activities for drug products in pulmonary diseases. Reporting to the Senior Director of Clinical Science, you will collaborate closely with the pulmonary Medical Director, clinical pharmacology, program management, clinical operations, biostatistics, and data management groups. This cross-functional role includes assembling, evaluating, and presenting scientific and medical data, assisting with writing manuscripts (paper, abstracts, posters, etc.), and reviewing and summarizing relevant literature. Responsibilities will also include biomarker analysis, data review and trial startup activities for future studies.

You will contribute to the creation and maintenance of a clinical development plan leading to critical decision points for new indications in the development of client drug and other potential drug candidates in pulmonary disease. Applying your strong scientific background with a focus in pulmonary disease and translational medicine, you will clearly communicate concepts and information both in writing and via formal presentations to scientific and medical experts both internally and externally. Someone who can think creatively, function independently, has good strategic insights and knowledge of the activities and procedures involved in clinical drug development and translational science, while having fun along the way, would be a great fit for our group!

Job Responsibilities:

  • Collaborating with the clinical development team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting

  • Providing scientific input to protocol development and helping define efficacy and safety endpoints for all pulmonary studies

  • Preparing data and contributing to scientific publications including posters, abstracts and manuscripts

  • Working as part of an integrated drug development team, you will contribute to the clinical strategy and creation of the clinical development plans for pulmonary indications for one or more drugs

  • Providing scientific input to the preclinical pharmacology team for translational studies of interest including biomarker development strategies

  • Supporting the Medical Monitor with the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals

  • Participating in the identification of appropriate external investigators and consultants

  • Developing and cultivating relationships with external partners such as clinical investigators, clinicians, scientists, and vendors

  • Providing support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations

  • Understanding competitive landscape and providing insights on strategic development pathways

  • Proactively seeking out and recommending process improvements

  • Anticipating potential study problems and preparing contingency plans as needed

  • Communicating clearly and precisely with all levels of the company globally

Qualifications/ Requirements:

  • MD, PhD or PharmD, or equivalent with clinical research experience

  • At least 2-5 years of technical/operational experience in planning, executing, reporting and publishing clinical studies

  • Strong scientific background, with clinical and/or research experience in pulmonary disease (e.g. pulmonary arterial hypertension)

  • Comprehensive understanding of the drug development process in all phases of testing with emphasis on Phase 2 and 3 clinical studies

  • Familiarity with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements

  • Strong analytical and strategic thinking skills

  • Experience interacting with clinical investigators and medical experts

  • Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required)

  • Willingness to travel up to 10%

Demeika Roberts

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