Wanted – Scientific Thought Leaders to Drive Healthcare Product Development
The Cerneos Group, LLC is seeking scientists to drive innovation programs in healthcare product development. We are a life science consultancy in the fields of product development, scientific consulting, regulatory affairs and clinical development. We are a village for development. We reduce pain by providing clarity.
It’s a chance to work with the brightest entrepreneurs in the Biotech, Medical Device and Diagnostic innovators and drive international regulatory efforts:
· 100% Remote work and flexible scheduling
· Training, professional development and networking opportunities
· Academic freedom and control of your projects
· Thought leadership in a variety of fields
· Develop your portfolio of scientific innovations
· Be “in the room” when important healthcare decisions are made
· Recognition from the scientific community and industry
· Opportunities to network, publish and be a thought leader
· Introductions to the leaders in healthcare innovation
· Encouragement of diversity in all programs
· Competitive rates for consulting
Cerneos needs scientists in the fields of: (A combination of several fields is desired)
· Gene Therapy
· In-Vitro Diagnostics
· Cell Biology
· Women’s Health
· Microbiome Science
· Public Health
· Infectious Diseases
· Autoimmune Disease
· Personalized Medicine
· Behavioral Health
Cerneos needs Science Consultants to oversee science consulting activities for Cerneos Group.
Chief Scientific Officer (CSO):
Leadership of Cerneos science and public health programs and acting as resident expert in a variety of life science and public health fields. Published scientific/public health author with extensive peer reviewed research publications and experience as an investigator or principal investigator in corporate, government or academic programs. Familiarity with current analytical, laboratory, engineering and bioprocess techniques. Experience in conducting, managing, supporting or documenting clinical trials desired but will train qualified candidates.
CSO will provide intelligence on developing sciences and trends in a variety of fields. CSO will publish articles in a variety of fields and act as a resource to Cerneos and clients. Management experience preferred but can train in business development, regulatory and technical fields as needed. CSO will act as a resource in client and Cerneos staff training and development and maintain competitive scientific intelligence. Must have excellent communications, writing, publishing, creative and diplomatic skills.
Senior Scientific Consultant:
Specialist in one of more fields to meet client needs to develop medical and healthcare services. Familiarity with current analytical, laboratory, engineering and bioprocess techniques. Will provide intelligence on developing fields and trends in a variety of fields. Will support client, science department and regulatory department needs on a project to project basis. Must be proficient in literature research, scientific writing, technical communication. Must have the ability to translate complex scientific concepts to all levels of workers and stakeholders.
May be called upon to conduct timely literature research and evaluations in support of client projects. Advanced degree in science and/or public health desired. Prefer candidates with a combination of academic, pharmacy, laboratory, corporate, medical, public health or government experience. Experience with clinical trials desired. Cerneos will be willing to train candidates on clinical research requirements and documentation.
Senior Science CMC Consultant:
Chemistry and Manufacturing Controls (CMC) specialist needed for development, preparation and scientific writing of documentation needed on biotech, drug, combination product and biologic and biosimilar regulatory submissions. Have demonstrated ability to interpret scientific, analytical, clinical, engineering and laboratory data from a variety of client stakeholders and synthesize information into formats acceptable for regulatory submissions.
Specialist in one of more fields to meet client needs to develop medical and healthcare services. Familiarity with current analytical, laboratory, engineering and bioprocess techniques. Ability to explain current technology and client information to a variety of stakeholders including client corporate leadership and international regulatory authorities. Provides leadership in CMC development and international strategy. Advanced degree and corporate experience in IND, BLA and NDA submissions desired. Cerneos will be willing to train candidates if they have sufficient writing and technical communications skills.
· Provide scientific content and advising to Cerneos and Cerneos clients
· Scientific, CMC and Medical Writing in support of FDA and international regulatory filings
· Conduct literature searches in support of client development projects
· Oversight of scientific and clinical investigations in support regulatory projects
· Coordination with other service providers on projects
· Be client facing and maintain market and regulatory intelligence functions
· Identify gaps in scientific and clinical data from client product documentation.
· Life Science background with industry experience
· Advanced Degree and RAC Certification preferred but not essential
· Strong diplomatic, writing, presentation, negotiation & communications skills
· Corporate and consulting experience preferred
· Understanding of product & regulatory needs in biotech & devices
· Willing to learn new product areas and extend into new business areas
· Drive to implement new programs and execute marketing plans
Immediate needs projects:
• Help develop educational webinars and podcasts
• Update regulatory intelligence on COVID, MDR and IVDR requirements
• Support research in CNS, immunology, microbiome and infectious diseases.
• Independence on scheduling and operations
• Remote operations and virtual business
• Professional, business development and networking opportunities
• Support for continuing education
• Key scientific person on all accounts
• Competitive rates based on candidate experience, proficiency and client needs.
• Travel and expenses covered for events
• Potential for partnership in Cerneos for senior positions
• Contract -1099 or Corp to Corp relationship
• Maintain confidentiality on all operations and client programs
• Must be eligible to work in the USA for any employer
• Maintain contract integrity with all clients
• Agree to abide by RAPS Code of Ethics
• Re-Evaluation after 1 year
• Provide 2 Week notice if you need a break or to terminate contract
Richard Tharin, MS, RAC
The Cerneos Group, LLC
Please provide resume and/or professional profile and Linkedin profile and/or professional website links and list of publications.
No Phone Calls Please
WELCOME TO CERNEOS GROUP
To see and to solve
New solutions for life science & medical products
A Village for Development
We reduce pain by providing clarity