Note: The job is a remote job and is open to candidates in USA. Fortvita Biologics is seeking a Senior Clinical Scientist to join their Clinical Development team. The role involves designing, monitoring, and analyzing data from clinical trials, ensuring the successful completion of necessary documentation, and collaborating with cross-functional teams to optimize product development.
Responsibilities
- For clinical trials: design, provide oversight, and support site and subject retention
- Ensure successful completion of documents (including clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
- Participate on study teams and cross-functional teams as appropriate, and as delegated by the Vice President, Clinical Development
- Ensure consistent use of language and criteria across multiple endocrine projects
- Ensure study integrity, and track accumulating safety and efficacy data
- Anticipate obstacles within a clinical trial, and implement solutions
- Analyze, evaluate, and support accurate interpretation and reporting of clinical data
- Contribute to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions
- Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
- Collaborate with and serve as a clinical research resource for cross-functional colleagues to optimize product development
- Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company Support corporate strategic and organizational initiatives
- Assist with commercial activities as needed
- Complete assigned tasks thoroughly, accurately, and on time
- Adhere to rigorous ethical standards
Skills
- Advanced degree e.g. Ph.D., Pharm.D., MS, or equivalent
- Strong track record of scientific and clinical inquiry
- Understand statistical concepts and clinical trial design
- Understand the connection between nonclinical data and clinical data
- At least 4 years of experience with clinical trial design and execution
- At least 4 years of pharmaceutical industry experience
- Experience with regulatory submissions and interactions
- Possess excellent communication skills (both written and verbal)
- Learn quickly, follow complex directions under pressure
- Multi-task while remaining organized and attentive to details
- Work hard, be a trustworthy and collaborative team player
- Take initiative and solve problems of moderate complexity
- Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
- Lead both directly and by example
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