Scientific and Ethics Committee: Toxicology and Safety Specialist
An inaugural seat on the Scientific and Ethics Committee. Reviews known and plausible toxicity, drug-herb interactions, dose justification, exclusion criteria, safety monitoring, adverse-event attribution, and escalation rules. This is one of seven named seats on the Scientific and Ethics Committee, recruited individually so that candidates can see exactly which seat they are applying for and what it requires.
How this seat counts toward Committee composition
These are roster-level requirements satisfied across the whole Committee, not separate seats. They are why candidates are assessed against the resulting Committee rather than in isolation.
- Primarily scientific: Yes
- Primarily non-scientific: No
- Wholly unaffiliated: No
Required
- PhD, PharmD, MD, DO, veterinarian, or equivalent
- Toxicology, clinical pharmacology, safety, or adverse-event expertise
Preferred
Strengthens an application. Not disqualifying if absent.
- Pharmacovigilance or signal-detection experience
- Experience with drug-herb or drug-supplement interaction assessment
- Prior DSMB or safety-monitoring service
What this seat reviews
- Known toxicity and the toxicity that is plausible but unstudied
- Drug-herb and drug-supplement interactions
- Dose justification and the basis for the proposed exposure
- Exclusion criteria and who should not be enrolled
- Safety monitoring plans and their trigger points
- Adverse-event attribution and the discipline of not explaining events away
- Escalation rules and who is empowered to stop a study
Expected workload
Concentrated at protocol review, then recurring whenever safety data accumulate.
- Compensation
- Volunteer (uncompensated appointment)
- Participant-facing
- No
- Credential required
- Yes
- Training before activation
- Yes
- Conflict review
- Full disclosure & review required before appointment
- Seat status
- Open
- Classification
- Scientific
- Term
- Three years. Initial terms are staggered so the whole Committee does not turn over at once. Proposed charter term, subject to Board adoption.
- Estimated future need
- Recruiting now: required before the first study can open
Important boundaries
- The Committee is not yet seated. No human-subject or animal-subject research commences until the Board confirms that all mechanisms required by the Framework are operational (§13.2). Before such research begins the Board must either seat this Committee or retain an external IRB, IACUC, or other independent ethics body qualified under applicable law to perform its functions (§3.1). Herbal Trials is seating the Committee.
- This Committee is an institutional scientific-governance and pre-review body. It does not replace an Institutional Review Board. No human-subject study may open solely on the Committee's review; applicable studies must also receive approval from an appropriately constituted independent IRB.
- Members review protocol design, botanical standards, manuscripts, and evidence grading. They do not conduct the research they review.
- The Committee has independent authority to approve, require modifications in, disapprove, suspend, or terminate any research activity within its jurisdiction. No officer, director, funder, or other person shall override a determination of the Committee except through a documented appeal to a second independent ethics committee (Framework §3.4).
- No member may participate in the initial or continuing review of a project in which the member has a conflicting interest, except to provide factual information. Members sign annual conflict-of-interest disclosures (Framework §3.3).
- Appointment is by the Board to a specifically identified seat, after qualification, conflict, interview, and composition review. Support for herbal medicine or for the organization's mission is not a qualification.
What your application includes
- Profile & contact
- Governance & independence
- Conflict-of-interest disclosure
- Document uploads
What to have ready
A CV or résumé is part of every profile. For this role, also have:
- Independence & conflict-of-interest attestation
- Statement of interest
- Publications, committee service, or oversight experience
What we’ll ask you
How you run the day-to-day of a study, and how you protect the people in it. Everyone also answers a few shared questions on research integrity and why this work. You answer these in your private portal after verifying your email. Your answers are stored with your private application and may be reviewed by authorized personnel when the role becomes active. They are never scored or rejected solely by an automated system.
- Walk us through how you'd run an informed-consent conversation from greeting to signature, including how you'd handle a participant who seems unsure.
- The day before a monitoring visit, a source document and the EDC don't match. What do you do?
- How do you keep a demanding recruitment or visit schedule without ever pressuring or over-promising to a participant?
- Describe your coordinator experience — study types, systems (EDC/CTMS), consent and source documentation — and what you handled independently. (optional)
- Participant safety and honest data sometimes conflict with hitting enrollment targets. How do you hold that line? (optional)
Asked specifically for this seat
- Describe an adverse event you believed was under-attributed, and how you handled it.
- How do you justify a dose when the human data are thin?
- What would make you recommend stopping a study?