Clinical Development Director
Summary of Major Responsibilities
The Clinical Development Director is responsible for the development of clinical evidence plans, clinical development strategies, and study designs to support clinical validation of IVD products. This position works with cross-functional study teams to design and execute clinical studies, including data interpretation, clinical study report writing and scientific communication (abstracts, publications, presentations, etc.). This position reports to the VP, Clinical & Regulatory.
Essential Duties and Responsibilities
- Develop clinical evidence strategy, create clinical development plans, conceptualize and author clinical protocols,
- Collaborate with KOLs, biostatisticians, and outside consultants to provide clinical science inputs into clinical plans
- Write abstracts, manuscripts, and clinical study reports
- Provide support in preparation for scientific meetings (for example, advisory boards, consultant meetings and investigator meetings), regulatory submissions, and labelling documents.
- Coordinate review of clinical study data, including gathering, analyzing, reviewing, and interpreting data. Provide preliminary assessments and recommendations
- Support assessment of issues relating to protocol conduct and subject safety
- Participate in and present at scientific meetings, advisory boards, and investigator meetings
- Conduct and prepare literature reviews as needed
- Contribute to the authoring and revision of regulatory submissions
- Facilitate communication of relevant scientific, clinical, or other findings to both internal and external stakeholders
- Collaborate with other functions including Clinical Operations, Medical Affairs, Regulatory Affairs, R&D, and Commerical/Marketing, as needed
- Travel expected up to 30%
- PhD, PharmD, or MD in a life science or health science related field
- 6 years experience in medical device/IVD, biotech or pharmaceutical industry experience in preferable with clinical development or clinical research
- Experience or research in oncology, molecular biology, biochemistry, or related field
- A comprehensive understanding of the medical device development process and testing standards for IVDs
- Excellent scientific writing skills and interpersonal communication skills
- Basic understanding of biostatistical principles for study design and data analysis
- Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day
- Ability to sit for an extended period of time
- Ability to stand for extended periods of time and up to 6 hours at a time
- Ability to operate telephone system and computer keyboard and printer
- Ability to lift and move up to 40 pounds on an occasional basis
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.
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