Clinical Scientist - Associate Director Clinical Science
Proclinical is currently recruiting for an Associate Director of Clinical Science for a biopharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for providing scientific support for clinical development activities for drug products in pulmonary diseases.
- Provide scientific input to clinical trial protocol development and helping define efficacy and safety endpoints for all pulmonary studies
- Participate in the generation of case report forms for future studies to ensure we are collecting all necessary information in the most appropriate way
- Understand competitive landscape and provide insights on strategic development pathways
- Work as part of an integrated drug development team; contribute to the clinical strategy and creation of the clinical development plans for pulmonary indications for one or more drugs
- Collaborate with the clinical development team on the review, analysis, and interpretation of study results
- Prepare data and contribute to scientific publications including posters, abstracts and manuscripts
- Support the Medical Monitor with the development of program documents
- Participate in the identification of appropriate external investigators and consultants
- Anticipate potential study problems and prepare contingency plans as needed
- Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors
- Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations
- Proactively seek out and recommend process improvements
- Communicate clearly and precisely with all levels of the company globally
- Provide scientific input to the preclinical pharmacology team for translational studies of interest including biomarker development strategies
Skills and Requirements:
- MD, PhD or PharmD, or equivalent with clinical research experience
- 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 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%
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.