Consultant II / Senior Consultant – Advisory Services (Clinical Strategy & Evidence Generation)

Avania•,

6d•$100,000 - $150,000•Remote

About The Position

This is a role for someone who has designed and been a part of executing clinical studies. You will sit across from a client's clinical and regulatory team, look at the evidence they have and the claims they want to make, and be able to tell the difference between a study that will satisfy an FDA reviewer and one that will generate a deficiency letter. You will then help them bridge those gaps and take that study design to FDA in a presubmission meeting, negotiating the details of the protocol. When clients come to us later (i.e. after already submitting their 510(k), De Novo or PMA), you will build the argument that defends their existing evidence: data analysis strategy, literature review, and where necessary a proposal for the additional study that closes the gap. Most of the studies we work on are experimental -- sham-controlled randomized trials and device accuracy/validation studies (i.e. comparing data from a novel device to "ground truth"), though we also work on single-arm studies for pre-market approval and post-market surveillance (i.e. observational or retrospective with a single arm benchmark comparison or matched comparator). We work on software as a medical device including digital therapeutics, IVDs (especially on the software that interprets diagnostic tests), and a steady stream of AI-enabled therapeutic and diagnostic products, though we also work on many other device types in neurology, cardiology, aesthetics. Comfort moving between very different clinical contexts matters more than deep expertise in any single therapeutic area. Level of prior experience required is dependent on rank. This role reports directly to the VP of Regulatory & Compliance Services, who currently leads the clinical research advisory practice. General Responsibilities This role goes beyond summarizing what you are told in a protocol or filling in a template — it's strategic. You will work through a client's clinical evidence at a level of detail that lets you catch where an endpoint will not support the claim, where a control arm will not hold up, where a sham fails to adequately control for expectancy effects, or where a statistical analysis plan isn't written in FDA's "language." You will turn that review into presubmission packages, study designs, protocol input, clinical evidence summaries, and deficiency responses built to survive an FDA reviewer's scrutiny. You will also be trained on the wider regulatory work this team delivers, including 510(k) and De Novo submissions and their supporting documentation, and supported in earning the certifications that go with it. We expect you to arrive with a solid clinical research foundation and to build the regulatory layer on top of it here. The level of training you'll be provided, and the level of initial client management responsibility expected of you right away, is dependent on your level of experience and rank (see below).

Requirements

Designed and executed clinical studies.
Solid clinical research foundation.
Ability to move between very different clinical contexts.

Nice To Haves

Deep expertise in any single therapeutic area.

Responsibilities

Design and execute clinical studies.
Analyze existing clinical evidence and proposed claims to determine if they will satisfy FDA reviewers.
Bridge gaps in clinical evidence to satisfy FDA requirements.
Take study designs to the FDA in presubmission meetings and negotiate protocol details.
Build arguments to defend existing evidence for clients who have already submitted their 510(k), De Novo, or PMA.
Develop data analysis strategies, conduct literature reviews, and propose additional studies as needed to close evidence gaps.
Work through client's clinical evidence to identify potential issues with endpoints, control arms, sham procedures, or statistical analysis plans.
Create presubmission packages, study designs, protocol input, clinical evidence summaries, and deficiency responses.
Receive training on broader regulatory work, including 510(k) and De Novo submissions and supporting documentation.
Work towards earning relevant certifications.