Join the SciLucent Team
SciLucent encourages scientific and regulatory professionals to contact us regarding employment opportunities. If you do not see any positions listed below, we currently are not actively recruiting for any positions, however, we always welcome inquiries, and resumes submitted will be considered for upcoming open positions.
NONCLINICAL CONSULTANT - STUDY MONITOR / OUTSOURCING
SciLucent, Inc., a Northern Virginia-based scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, seeks a mid-level experienced scientific professional with a strong nonclinical study monitoring background to join our team of experienced professional toxicology consultants. We are looking for an enthusiastic, adaptable, self-motivated individual with excellent communication skills.
Responsibilities of the position include:
- Manage all aspects of outsourced nonclinical studies including study design, competitive bidding, pre-study activities, study monitoring, data and report review.
- Monitor the studies including site visits, as needed, to ensure scientific, regulatory, compliance and animal welfare regulations expectations are met and quality reports are delivered on agreed upon timeline.
- Provide technical and scientific nonclinical study advice for a wide range of study designs, route of administration, and species commonly used in drug development.
- Provide regulatory toxicology support to clients.
- Author reports and/or regulatory documents as needed.
- Interact with clients and vendors.
- Provide scientific and innovative advice to internal and external parties.
- Participate in business development activities.
The ideal candidate will have the following:
- Bachelor’s degree, in a scientific field (e.g., biology, chemistry, biochemistry, etc.), is required.
- Prior experience in Study Directorship or coordination in a Contract Research Organization (CRO) is highly desired.
- A minimum of 4 years in the pharmaceutical/biotechnology industry, CRO, and/or consulting with significant study monitoring experience.
- Good understanding of technical study conduct, study design, procedures, and documentation practices and regulatory requirements.
- Proven knowledge of Good Laboratory Practices (GLP).
- Demonstrated organizational and project management skills.
- Strong computer skills (e.g. Microsoft Word, Excel, PowerPoint, etc.).
- Ability to work independently and within a group setting and to interact effectively with different functional areas.
- Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
- Available to travel 30 – 70% of the time.
Both local and remote applicants will be considered and are encouraged to apply. We are a small company and at this time are unable to sponsor candidates for employment. We offer a congenial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.
Please send a resume and cover letter to email@example.com. Applications without cover letters will not be reviewed.
SciLucent is an equal opportunity employer. We thank all applicants for their efforts in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.
SENIOR REGULATORY TOXICOLOGY CONSULTANT
SciLucent, Inc., an independent Northern Virginia-based scientific consulting firm is seeking and experienced and seasoned Regulatory Toxicologist to join our multidisciplinary consulting team. The individual will work within the Nonclinical Safety & Development group and provide support to project teams and clients to develop and execute strategic and integrated nonclinical development programs for drugs, biologics, devices, and combination products in multiple therapeutic areas. The successful applicant will be able to work in a team environment and provide expert scientific and regulatory services while requiring minimal supervision for primary job functions and responsibilities.
- MS degree in toxicology or a related and relevant scientific field
- 10 or more years experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, and/or contract service industries
- Prior experience and knowledge in working with Contract Research Organizations (CRO)
- Must possess current knowledge and expertise in regulated drug development processes
- Track record of successfully authoring quality nonclinical regulatory documents
- Knowledgeable in regulatory guidance documents, precedents and GLP regulations
- Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure
- Strong sense of teamwork and demonstrated experience working with project teams, clients and regulatory personnel
- Must be detail-oriented, with an ability to think critically and innovatively
- Must have a client service minded attitude and be able to travel (when restrictions on business travel are eased)
Essential Duties and Responsibilities:
The candidate will devise and execute integrated nonclinical development strategies to support the development activities of drugs, biologics, devices, and combination products. Job responsibilities include:
- Advise, guide, and design integrated national and international nonclinical drug development strategies for our clients
- Provide oversight and management of program outsourcing activities
- Review, analyze, and interpret scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies
- Author and/or critically review nonclinical submission packages for scientific content and quality
- Act as nonclinical representative for Agency interactions and meetings
- Conduct scientific assessments (e.g., gap analysis, safety assessments)
Please send a cover letter and curriculum vitae or resume to firstname.lastname@example.org.
Both local and remote applicants will be considered and are encouraged to apply. We offer a collegial work environment, the opportunity to work with knowledgeable consultants, a competitive salary, flexible benefits, retirement plan, generous paid time off plan, profit sharing, and a tremendous opportunity for growth.
SciLucent is an equal opportunity employer. We thank all applicants for their interest and effort in applying for our open position; while all applicants will be considered, only candidates selected for interviews will be contacted.
Send a cover letter and CV or resume
SciLucent offers a congenial work environment, the opportunity to work with knowledgeable consultants in multidisciplinary teams and learn the business of healthcare product development, a competitive salary, flexible benefits, profit sharing, and a tremendous opportunity for growth.
SciLucent is committed to equal employment opportunity as a sound business practice. Employment practices will not be influenced or affected by an applicant’s or employee’s race, color, religion, sex, national origin, age, disability, sexual orientation, marital status, or any characteristic protected by law. Please see the two links below for important notices for job applicants and employees:
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Equal Employment Opportunity Commission: https://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf