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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.

SciLucent, Inc. (www.scilucent.com), a partially employee-owned Northern Virginia-based scientific consulting firm is dedicated to providing innovative solutions in all aspects of drug development.  We are committed to helping our clients navigate the complexities of the pharmaceutical industry to achieve their goals.

We are seeking an experienced Regulatory Toxicologist to join our multidisciplinary consulting team as an Associate Principal or Principal Consultant, depending on level of knowledge, skills, and experience. This senior role within the Nonclinical Safety & Development team requires a professional capable of operating with a high degree of independence across the services we offer. The successful candidate will be expected to lead nonclinical strategy development and client engagements, design and oversee studies, provide regulatory and scientific guidance and authoring, and represent SciLucent as a subject-matter expert in the development and execution of programs for drugs, biologics, devices, and combination products across multiple therapeutic areas.

Essential Duties and Responsibilities:

  • The candidate will devise and execute moderately complex to complex integrated nonclinical development strategies to support the development activities of drugs, biologics, devices, and combination products.
  • Act as a trusted advisor to drug development clients, providing strategic support on nonclinical strategies and activities
  • 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 complex 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)
  • Assist in the preparation of proposals and presentations tailored to client needs and business development goals

Job Requirements:

  • Advanced degree (PhD or MS) in toxicology or a related and relevant scientific field
  • 7 or more years’ experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, life sciences consulting and/or contract service industries
  • Prior experience and knowledge in working with Contract Research Organizations (CRO) including general study design and conduct, study monitoring, technical and scientific aspects of study execution including common routes of administration and species
  • Must possess current knowledge and expertise in regulated drug development processes
  • Excellent 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
  • Demonstrated track record of managing multiple projects and client accounts simultaneously, preferably in a consultancy setting
  • Ability to synthesize complex technical information and present it clearly to diverse audiences.
  • Must have a client service minded attitude and be able to travel

This is a remote position working from your home location with travel as needed for client and business needs. We are a small company and at this time are unable to sponsor candidates for employment.

Our most valuable resource is our people.  We hire intelligent, creative, passionate professionals with a strong desire to learn.  At its core – collaboration, camaraderie, growth, and collective hard work without egos – our culture is one that encourages, supports, and celebrates our colleagues!  We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.  Additionally, we offer the following benefits:  medical, dental, vision, FSAs, HSA, EAP, Life insurance, disability insurance, 401K with company contribution, ESOP, Holidays, and PTO.  The annual base salary for this position ranges from $85,000 – $175,000 depending on qualifications and experience.  Any offered salary is based on internal equity, internal salary ranges, market data/ranges, applicant’s skills and prior relevant experience, certain degrees, and certifications.

Please send a cover letter and curriculum vitae or resume to [email protected].  Applications without a cover letter will not be reviewed.

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.

SciLucent, Inc., an employee-owned (ESOP) Northern Virginia-based scientific consulting firm providing innovative solutions in all aspects of drug development.  We are committed to helping our clients navigate the complexities of the pharmaceutical industry to achieve their goals.  Our scientific/regulatory consulting team is expanding, and we are seeking a mid-level experienced scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants.  We are looking for an enthusiastic, adaptable, self-motivated individual with excellent English communication skills.

Responsibilities of the position include:

  • Develop and provide strategic CMC regulatory guidance to clients including planning, authoring, and managing the production of clear and persuasive CMC-related regulatory submissions for pharmaceuticals, biologics, and combination products such as INDs, NDAs/BLAs, meeting requests, and meeting packages.
  • Support regulatory agency interactions, including preparation for meetings and responding to information requests.
  • Develop, manage, and ensure that overall project timelines support the coordination and preparation of timely submissions.
  • Communicate and coordinate with relevant internal and external clients and team members to identify and ensure the preparation of required CMC documentation and data needed for regulatory submissions.
  • Act as regulatory CMC representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
  • Maintain up-to-date working knowledge of relevant regulatory regulations, guidance, and the current regulatory environment.
  • Provide mentorship to internal team members through sharing of information on regulatory CMC issues.

Qualifications

Required

  • Master’s degree or equivalent experience in a scientific field (e.g., biology, chemistry, biochemistry, etc.).
  • A minimum of 10 years in the pharmaceutical/biotechnology industry and/or consulting with at least 8 years in CMC Regulatory Affairs.
  • Strong understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
  • Experience with CTD format and content.
  • Ability to work independently and within a group setting and to interact effectively with different functional areas, exercise sound judgment, and take ownership of deliverables.
  • Excellent communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • Excellent ability to critically analyze and interpret scientific data, interact with scientific professionals
  • Excellent understanding of complex to highly complex product development, the product industry, and regulation
  • Strong ability to identify, develop, grow the client base and build and cultivate repeat, long-term relationships
  • Strong business acumen
  • Strong computer skills using MS Word, Excel, PowerPoint.

Preferred

  • Prior regulatory consulting or client‑facing experience.
  • Experience with small molecules and/or biologics.
  • Familiarity with accelerated development pathways and global regulatory strategies.

Employees work remote from their home office which must be located in the United States. Our most valuable resource is our people . We hire intelligent, creative, passionate professionals with an ardent desire to learn. At our core is collaboration, camaraderie, growth, and collective hard work, without egos. Our culture is one that encourages, supports, and celebrates our colleagues! We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development. Additionally, we offer the following benefits:  medical, dental, vision, FSAs, HSA, EAP, Life insurance, disability insurance, 401K with company contribution, ESOP, Holidays, and PTO.  The annual base salary for this position ranges from $115,000 – $215,000 depending on qualifications and experience.  Any salary offered is based on internal equity, internal salary ranges, market data/ranges, applicant’s skills and prior relevant experience, certain degrees, and certifications.

Please send a resume and cover letter to [email protected].  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.

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.

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    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

    For other information regarding employment:

    Human Resources
    SciLucent
    10505 Judicial Drive, Suite 300
    Fairfax, VA 22030
    [email protected]