Job type contract
Full job description
We are seeking an experienced medical device early development scientist with strong experience including device regulatory regulationsThis position can be remote and based anywhere in the usa!
Job summary
Early development scientist reports to the associate director- early development, and is responsible for the day-to-day non-clinical research activities and ph1 (including first-in-human)/pk-pd or proof-of-concept trials across multiple therapeutic programs.
Key responsibilities:
Early development planning, operations and execution (75%)
Execution of drug discovery research and preclinical activities to enable robust, timely and compliant ind submissions with clear development paths.
Development of pre-clinical (in-vivo/ex-vivo/animal study) & ph1/pk-pd/proof-of-concept clinical study designs.
Write pre-clinical and clinical protocols & study reports of other documents.
Maintain and update of the early development project folders/drives.
Work closely with associate director- early development to identify the new target opportunities, and initiate additional pipeline programs.
Work closely with associate director- early development to support the evaluation of in-/out-licensing opportunities
Work closely with associate director- early development to support endo’s intellectual property strategy and patent portfolio
Work with publication team to prepare a robust publication plan in leading journals, and present findings at key meetings
Participate in recruiting, coaching and developing internal talents
Maintain a culture of collaboration, innovation, discovery, and cutting-edge research culture focused on scientific excellence, open communication, and continual improvement
Regular and ad-hoc data reviews and interpretation; prepare and present summaries/documentations of these reviews.
Identify, contract and engage subject matter experts/thought leaders in advisory board meetings, consultancy etc.
Participation in vendor selection, specification development, and management/oversight.
Develop/coordinate study training for study team, investigational sites, and vendors.
Handle all scientific and data-related queries from vendors, thought leaders and/or team members.
Participate and prepare documents necessary for ind submissions.
Safety & efficacy (25%)
Collaborate with business operations to identify potential vendors for executing pre-clinical studies.
Collaborate with the clinical safety scientist to identify any potential safety concerns/issues w.r.t novel ideas/concepts, pre-clinical data and/or ph1/pk-pd/poc study trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
Collaborate with the statistician to identify any pre-clinical and/or clinical study related safety and efficacy trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
Qualifications:
Education & experience:
Advanced scientific degree (phd/pharmd/masters degree)
At least 5 years of experience in clinical development within industry (pharmaceutical, cro)
Prior experience designing and developing pre-clinical and clinical study protocols.
Good therapeutic area experience.
Good experience in the principles and techniques of data analysis, interpretation and clinical relevance.
Previous project management experience desirable.
Knowledge:
Has extensive experience and knowledge of successfully working across pre-clinical development projects.
Has fair to good experience and knowledge of successfully working across clinical development projects.
Comprehensive understanding of product and safety profiles.
Well-versed in medical aspects of gcp, glp, gmp, ich, fda, emea, and other relevant guidelines and regulations.
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