Clinical Trial Jobs in Maryland.
All active Clinical Trial roles based in Maryland.
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VP, Clinical Development - Infectious Disease
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Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Position Overview
The Vice President (VP), Clinical Development - Infectious Disease is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer, this position provides strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic area of Infectious Diseases, initially with focus on prophylactic monoclonal antibodies, live virus vaccines and Lyme disease.
Essential Duties
- Define and lead the company’s clinical development strategy for assigned vaccines and prophylactic antibodies, ensuring alignment with corporate vision and regulatory expectations with Tonix’s pipeline and therapeutic focus.
- Oversee the planning, design, execution, and completion of clinical trials (Phases I-IV), ensuring efficiency, scientific rigor, and compliance with regulatory standards, timelines, and budgets. Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents. Collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs. Maintain a strong focus on innovation in clinical trial design, patient-centric approaches, and biomarker-driven strategies.
- Oversee the selection and management of CROs, academic partnerships, and external collaborations to optimize clinical trial execution.
- Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations, and scientific integrity across Clinical Development.
- Represent the company at key scientific conferences, industry consortia, and investor presentations to enhance corporate reputation.
- Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
- Provide medical and scientific leadership to cross-functional teams, integrating insights from medical affairs, regulatory affairs, and commercial teams to drive program success.
- Partner with R&D, Medical Affairs, Commercial, and Business Development teams to align clinical development with broader corporate objectives.
- Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies, and post-approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and CTAs.
- Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and indications for the programs led.
- Build, mentor, and lead high-performing teams, fostering a culture of excellence, innovation, and accountability.
- Strong ability to build and sustain meaningful relationships with KOLs, regulatory bodies, and external strategic partners.
- Exceptional leadership, mentorship, strategic planning, and operational management skills.
- Excellent communication, interpersonal, and negotiation abilities
Necessary Skills and Abilities:
- Demonstrated success in leading clinical development programs.
- Regulatory Compliance: Extensive experience with regulatory interactions, submissions, and product approvals.
- Experience in comprehensive budget management.
Educational Requirements:
- MD or DO
Experience Requirements:
- Experience: 10-15 years of relevant experience, demonstrating progressive leadership in clinical development within pharmaceutical or biotechnology companies, including prior experience serving at the Senior Director level or above in Clinical Development organizations.
- Board certification in Infectious Disease a plus
- Expertise and experience in infectious diseases.
- Prior work with Lyme disease, live viral vaccines and or prophylactic monoclonal antibodies a major plus.
*Please note that Tonix does not offer sponsorship for this role.
Recruitment & Staffing Agencies
Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.
Compensation & Benefits
Tonix provides a comprehensive compensation and benefits package which includes:
- Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training
Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law. In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.
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Principal Investigator
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
We are seeking a highly skilled and experienced Principal Investigator to join our team. As the Principal Investigator, you will be responsible for oversight of all clinical trials according to study protocols, company processes, and GCP.
How You'll Make An Impact
- Provide overall medical oversight and medical review of protocols in conformance with good clinical practice
- Review sponsor provided safety reports.
- Review and maintain accurate case report forms.
- Ensure that the safety and well-being of all participants in the study at the trial site are protected
- Assess subject response to therapy, evaluate and address adverse experiences
- Perform physical assessments, examinations and study procedures as required by study protocols
- Train Sub-Investigators and study staff members on protocol and protocol specific procedures. Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
- Review the inclusion/exclusion criteria, endpoint criteria, and investigational product use with the internal research team.
- Complete the necessary Care Access and protocol specific trainings
- Comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
- Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
The Expertise Required
- Excellent written and verbal communication skills
- Ability to effectively prioritize tasks in a fast-paced environment
- Attention to detail and ability to maintain confidentiality when handling sensitive information.
- Critical thinking, dynamic problem-solving skills
- Previous experience as a Principal Investigator is required; 2 years prior experience as a Principal Investigator or Sub-Investigator, preferred
- Training and certification in Good Clinical Practice (GCP)
- MD or DO with an active, unrestricted medical license (medical license must be valid in the state in which the research is conducted)
How We Work Together
- Location: Baltimore, MD. This role requires 100% of work to be performed on site.
- Travel: This is an onsite position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
- Walking - 20%
- Standing - 20%
- Sitting - 20%
- Lifting - 20%
- Up to 25 lbs
- Over 25 lbs
- Overhead
- Driving - 20%
- Exposure to blood borne pathogens - Yes
The expected salary range for this role is $200,000 - $400,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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Registration Reviewer
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Overview
Black Canyon Consulting (BCC) is searching for a Clinical Trials Data Quality Analyst to support the ClinicalTrials.gov. Operated by the National Library of Medicine (NLM), a component of the National Institutes of Health (NIH), ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical research conducted in the United States and around the world. Both registration and results submission are accomplished through the web-based Protocol Registration and Results System (PRS). Responsible parties commonly register trials and submit results prior to a journal publication. Unlike journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.
The successful candidate for this position will be responsible for reviewing results data submissions to ascertain whether they meet minimal review criteria for posting on ClinicalTrials.gov. Information regarding the ClinicalTrials.gov database and reporting requirements can be found at https://clinicaltrials.gov/policy/fdaaa-801-final-rule.
Duties & Responsibilities:
Job Responsibilities
- Perform quality assurance/quality control (QA/QC) reviews of clinical trial registration submissions for consistency with review criteria
- Gain and use a working knowledge of the ClinicalTrials.gov Protocol Data Element Definitions (https://clinicaltrials.gov/policy/protocol-definitions) and ClinicalTrials.gov registration review criteria (https://clinicaltrials.gov/submit-studies/prs-help/protocol-registration-quality-control-review-criteria)
- Clearly communicate (via email and record reviews) with “responsible parties” (e.g., clinical trial sponsors, designated principal investigators) regarding the consistency of clinical trial records with review criteria
- Perform general proofreading
- Create new documentation to help responsible parties submit their clinical trial records in accordance with established review criteria
- Post records in accordance with established deadlines
- Monitor data for trends or patterns of problems (e.g., consistent series of errors from a single data provider) and participate in process improvement efforts
- Support database management activities
- Serve as a liaison between data providers (e.g., NIH, industry, universities, and other organizations) and ClinicalTrials.gov
- Participate in weekly team meetings with NLM staff to discuss process improvement
Required skills and experience
- Bachelor’s degree from an accredited college in a biomedical science, public health, or related discipline with at least 2 years of professional experience
- Or a master’s degree in a comparable field with no professional experience
- Ability to work within a team environment and contribute to consensus-based decision making
- Ability to handle multiple tasks simultaneously and shift priorities as directed
- Ability to work efficiently with team members in a fast-paced environment
- Excellent oral and written communication skills
- Excellent interpersonal skills and ability to work with people at every level
- General computer skills with a proficiency in MS Word, Outlook, Excel, and PowerPoint
-
Clearance and Location Requirements
- Must be able to obtain and maintain a Public Trust clearance
- Must reside in and be authorized to work in the United States; candidates in the DMV area preferred
- All work must be performed within the United States
Preferred Qualifications
- Ability to identify and communicate data processing errors and content discrepancies or inconsistencies
- Ability to identify, analyze, and solve problems creatively and independently
- Experience in data management and quality assurance
- General knowledge in the conduct and reporting of clinical trials
Benefits and Salary
We attract the best people in the business with our competitive benefits package, including medical, dental, and vision coverage; a 401(k) plan with employer contribution; paid holidays, vacation, and tuition reimbursement.
We offer a competitive salary commensurate with experience and location. The targeted range for this position is $65,000 - $70,000.
If you enjoy being part of a high-performing, professional, technology-focused organization, please apply today!
Ready to apply?
Apply to Black Canyon ConsultingResults Analyst
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Overview
Black Canyon Consulting (BCC) is searching for a Clinical Trials Data Quality Analyst to support the ClinicalTrials.gov. Operated by the National Library of Medicine (NLM), a component of the National Institutes of Health (NIH), ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical research conducted in the United States and around the world. Both registration and results submission are accomplished through the web-based Protocol Registration and Results System (PRS). Responsible parties commonly register trials and submit results prior to a journal publication. Unlike journal articles that are reviewed by both scientific colleagues and editors, data submitted to ClinicalTrials.gov are not peer-reviewed prior to posting, however specific review criteria must be met.
The successful candidate for this position will be responsible for reviewing results data submissions to ascertain whether they meet minimal review criteria for posting on ClinicalTrials.gov. Information regarding the ClinicalTrials.gov database and reporting requirements can be found at https://clinicaltrials.gov/policy/fdaaa-801-final-rule.
Duties & Responsibilities:
Job Responsibilities
- Perform quality assurance/quality control (QA/QC) reviews of clinical trial results submissions for consistency with review criteria
- Clearly communicate (via record reviews, teleconferences, emails, workshops, etc.) with “responsible parties” (e.g., clinical trial sponsors, principal investigators, statisticians) to facilitate understanding of and adherence to submission requirements
- Gain and use a working knowledge of the ClinicalTrials.gov Basic Results Data Element Definitions (https://clinicaltrials.gov/policy/results-definitions) and ClinicalTrials.gov results review criteria (https://clinicaltrials.gov/submit-studies/prs-help/results-quality-control-review-criteria)
- Create new documentation to help responsible parties submit their clinical trial results records in accordance with established review criteria
- Devise and help implement strategies to improve the quality of submissions
- Support database management activities
- Serve as liaison between data providers (e.g., NIH, industry, universities, and other organizations) and ClinicalTrials.gov
- Participate in weekly team meetings with NLM staff to discuss process improvement
Required skills and experience
- Master’s degree in biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, biochemistry, etc.)
- 3+ years’ experience with standard mathematical concepts and statistics (correlations, trends, significance, etc.)
- 1+ year experience with standard quantitative measures for health studies
- Ability to work within a team environment and contribute to consensus-based decision making
- Ability to identify, analyze, and solve problems creatively and independently
- Ability to handle multiple tasks simultaneously and shift priorities as directed
- Ability to work efficiently with team members in a fast-paced environment
- Excellent oral and written communication skills
- Excellent interpersonal skills and ability to work with people at every level
-
Clearance and Location Requirements
- Must be able to obtain and maintain a Public Trust clearance
- Must reside in and be authorized to work in the United States; candidates in the DMV area preferred
- All work must be performed within the United States
Preferred Qualifications
- Ph.D. in biomedical science and/or mathematics-related discipline (epidemiology, biostatistics, neuroscience, biochemistry, etc.)
- Background knowledge relevant to understanding and interpreting clinical trial data and statistics
- 1+ year experience with analysis and reporting of clinical trial data
- Strong critical thinking, analysis, and problem-solving skills
- Ability to critically appraise clinical trial design and methodology and to identify internal inconsistencies in clinical trial data reporting
- Experience (via coursework and/or job duties) working with and interpreting the following concepts:
- Mean, median, least square mean, st.dev, range, interquartile range, confidence intervals, etc
- Frequency, incidence, proportion, percentage, rate, etc
- Time to event measures
Benefits and Salary
We attract the best people in the business with our competitive benefits package, including medical, dental, and vision coverage; a 401(k) plan with employer contribution; paid holidays, vacation, and tuition reimbursement.
We offer a competitive salary commensurate with experience and location. The targeted range for this position is $87,000 - $91,000.
If you enjoy being part of a high-performing, professional, technology-focused organization, please apply today!
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Apply to Black Canyon ConsultingResearch Literature Technical Specialist
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Overview
Black Canyon Consulting (BCC) is searching for a senior-level Technical Specialist to conduct systematic reviews and other systematic approaches by identifying, appraising, and summarizing all high-quality, evidence-based research on a specific question using transparent and reproducible methods within the domains of biomedical and health sciences and related fields. The ideal candidate will have experience in biomedical and public health research and research methods, experience working on an interdisciplinary research team, and demonstrated skills in locating, collecting, and synthesizing research literature.
- Define research questions, eligibility criteria, and create comprehensive study protocols.
- Design, document, and execute complex, comprehensive, transparent, and reproducible search strategies across multiple biomedical databases and information platforms, including MEDLINE, Embase, CINAHL, Cochrane Library, and trial registries and gray literature.
- Develop search strategies using controlled vocabularies and advanced techniques, ensuring transparency, reproducibility, and compliance with reporting standards.
- Manage search results, deduplicate records, and support citation management and screening workflows using systematic review tools and platforms, like Covidence, EndNote or Zotero.
- Deliver instruction and training on evidence synthesis methods, advanced searching, and biomedical information literacy to researchers and trainees.
- Perform title/abstract and full-text screening based on defined inclusion/exclusion criteria.
- Extract data and appraise the risk of bias/quality of included studies.
- Synthesize findings (qualitatively or via meta-analysis) for final reports.
- Contribute to manuscript preparation, and peer review related to biomedical evidence synthesis projects.
- Provide methodological consultation on systematic review standards, including PRISMA, Cochrane, JBI, and other evidence synthesis frameworks.
- Monitor trends in biomedical publishing, open science, and research data to inform best practices in systematic review support.
Required qualifications:
-
Master’s degree in library/information sciences, life sciences, social sciences, STEM, computer science, engineering, business, or related discipline.
-
A minimum of three (3) years of experience in:
- Advanced knowledge of biomedical information resources and indexing practices, particularly MEDLINE and related NLM products.
- Developing and executing targeted searching in biomedical, health sciences, and related databases, including grey literature
- Strong analytical skills in search strategy development, validation, documentation, and citation management.
- Demonstrated expertise in systematic review methodology and evidence synthesis standards, including synthesizing finding to provide analysis
- Experience working with interdisciplinary research teams in academic, clinical, or public health settings. Operating independently while contributing to a research team.
- Ability to communicate complex information concepts clearly in both written and oral formats.
- Proficiency with Excel or other spreadsheet/reporting platforms.
- Proficiency with EndNote, Zotero, Covidence, Mendeley or other reference management and research collaboration tools.
Benefits and Salary
We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, and tuition reimbursement.
We offer a competitive salary commensurate with experience and location. The targeted range for this position is $80,000 – $110,000.
If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!
Ready to apply?
Apply to Black Canyon Consulting