Clinical Development Director

Lever, Inc.

Northern (KY)

On-site

USD 330,000 - 370,000

Full time

5 days ago
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Benefits offered by this job

Medical/dental/vision coverage
401(k) with company match
Flexible PTO
Recharge break
Adoption assistance

Job summary

Enveda is a clinical-stage, AI-enabled biotech accelerating medicines discovery. We seek a Clinical Development Director to own the core development plan, design the first-in-human program, and map a path turning a novel mechanism into a transformational medicine across metabolism and autoimmune disease.

You will lead the Asset team with senior scientists and steer IND readiness. Join a fast-moving environment that prizes curiosity, collaboration, and impact.

Qualifications

  • MD with credibility to lead the program.
  • Experience designing and running early clinical development.
  • Proven ability to translate preclinical mechanisms into human readouts.

Responsibilities

  • Build the clinical development plan and first-in-human strategy from the ground up.
  • Design the Phase 1 protocol including endpoints and populations across two therapeutic areas.
  • Shape translational and biomarker strategy to support human proof-of-mechanism readouts.
  • Support IND readiness and early regulatory strategy.
  • Lead Advisory Boards to influence trial design and next steps.
  • Build KOL and site networks ahead of clinics.
  • Engage thought leaders and clinicians about the opportunity in metabolism and autoimmunity.
  • Contribute to the platform narrative for investors and partners.

Skills

KOL network
POC design
Translational PD

Education

MD

Job description

Let's build the future of medicine - together.

Remote| Full-time | $330K-$370K

YOUR ROLE

As a Clinical Development Director at Enveda, you won't be working on another me-too drug. You'll be working on a first-in-class opportunity with broad potential across metabolism and autoimmune disease, and it's one of the most exciting bets in our pipeline. You will own the core clinical development plan, design the first-in-human program, and build the path that turns a novel mechanism into a potentially transformational medicine in two therapeutic areas. This is a critical leadership role on the Asset team, where you will have a significant impact on its direction and success while collaborating with some of the brightest minds in the industry.

WHAT YOU'LL DO
  • Build the clinical development plan and first-in-human strategy from the ground up
  • Design the Phase 1 protocol: dose, endpoints, population, pharmacodynamic readouts, and the design nuance of testing across two therapeutic areas, plus the operational realism to make it run
  • Shape the translational and biomarker strategy that turns a preclinical mechanism into a credible human proof-of-mechanism readout
  • Support the path to IND and the early regulatory strategy behind it
  • Run Advisory Boards that produce decision-grade insight and genuinely change how we approach trial design and next steps
  • Build the KOL and site network ahead of the clinic, so we're ready to move when the study opens
  • Excite thought leaders, physicians, PIs, and patients about the opportunity in metabolism and autoimmune disease
  • Contribute to the broader platform narrative for investors and partners where scientific credibility is on the line
WHAT WE'RE LOOKING FOR
  • MD, with credentials that add actual and perceived credibility to the program
  • Live, warm global KOL and site network in autoimmune disease (metabolic disease as well is a plus)
  • Track record of taking assets into the clinic and landing non-trivial first-in-human and early-phase programs. Bonus points for at least one 'not just another X study' where design creativity was the unlock
  • First-hand experience designing and running early clinical development, particularly proof-of-mechanism studies in immune-mediated disease
  • Comfortable owning translational and pharmacodynamic strategy, not just trial logistics
  • Clinically creative and unlocked by clinical depth; strong strategic and scientific judgement
  • An undisputed champion for patients, someone willing to go to bat and change the paradigm, not just add another entry to it
  • The person colleagues call when they want a straight answer; well-regarded in the community in a substantive, not just social, way
  • Entrepreneurial by nature: comfortable with ambiguity, energized by building, motivated by impact over process
  • Ego-lite, Enveda culture: collaborative, direct, gets the work done without needing the spotlight

We hire for trajectory, not just credentials. If you meet most of the above and care deeply about this problem, we want to hear from you.

ABOUT ENVEDA

We're a clinical-stage, AI-enabled biotech discovering medicines four times faster than the industry standard. We recently raised $311M in a Series E. Forbes named us one of America's Best Startup Employers. Newsweek recognized us as a Top 100 Most Loved Workplace. We're building something rare - and we're just getting started.

BENEFITS (STARTING DAY 1)

Medical, dental, and vision covered at 90%, 401(k) with company match, flexible PTO and a company-wide weeklong recharge break, adoption assistance

OUR PROCESS

We move fast and respect your time. Typically: a recruiter screen → hiring manager conversation → work sample, technical interview, & culture interview.

OUR VALUES

Curiosity | Agency | Journey | Charity | Unity

ENVEDA IS PROTECTING JOB SEEKERS

We care deeply about creating a safe, respectful experience for every applicant, so we wanted to share a few guidelines to help you spot anything that doesn’t feel right.

  • You'll always meet real Enveda team members through video or in-person conversations before receiving an offer.
  • All communication from us will come from an @enveda.com or @envedabio.com email address.
  • We'll never ask you to purchase equipment, send money, or share sensitive banking details as part of any step in our recruiting process.

If something feels off or you're unsure whether a message is truly from Enveda, please reach out at anytime at recruiting@enveda.com.

At Enveda, we're building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms.

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