Clinical Operations Executive

Jeffery A.
Nieves, Pharm.D.

Doctor of Pharmacy  ·  Chandler, AZ

A Pharm.D. who has personally directed 20+ concurrent trials, administered $180M in program budgets, and co-authored the ASCO presentations that made those programs matter — bringing scientific authority to operations that most organizations have never seen in a single person.

20+Years in clinical ops
$180MPortfolios directed
10+ASCO / SITC / AACR
Ph I–IVFull development arc
Contact (773) 495-7072 jeff@jeffnieves.com
Location Chandler, AZ
Open to the right opportunity

Career Highlights

Three moments that
defined the trajectory

01
Portfolio Execution · Celgene
$180M. 20 studies.
9 weeks to first patient.

As Global Clinical Ops lead for Celgene's Hematology/Oncology division, administered $180M across 8 compounds and 20 simultaneous studies while mentoring 8 Senior Study Managers across three regional offices. The proof point: opening 3 trials for accrual within 9 weeks of final protocol delivery. The industry benchmarks this at 4–6 months.

02
Rare Disease Strategy · Ayala
A rare cancer.
A blank-page enrollment problem.

Led global ops for a precision oncology program targeting adenoid cystic carcinoma — a rare cancer with no approved treatments and a narrow biomarker-selected patient pool at a handful of specialist centers worldwide. Engineered the site feasibility and recruitment strategy that made multinational accrual viable at all, where standard playbooks didn't apply.

03
Function Buildout · Indaptus
Built the ops function.
Ran the trial. Published the data.

Joined Indaptus as the first clinical ops executive and built the entire function from scratch — SOPs, CRO framework, TMF, oversight architecture — while simultaneously running a Phase I/II IO program through dose escalation. Then co-authored 10+ peer-reviewed publications at ASCO, SITC, and AACR. Most ops executives do one of these things.

The Pharm.D. Difference

Scientific authority
inside the operations room

Most clinical ops executives understand the process. Jeffery understands the science behind it. A doctoral-level pharmacist who interrogates data, challenges protocol assumptions, and contributes to the regulatory narrative — not just executes it.

That distinction changes what he can do for a CMO or scientific founder. He doesn't need the science translated. He can sit across from a KOL, discuss mechanism of action, evaluate a site's patient population, and make enrollment decisions grounded in both operational reality and clinical judgment.

It's why he has been the author, not just the signatory, on presentations at ASCO, SITC, and AACR throughout his career — contributing original scientific thinking alongside the teams whose programs he operationalizes.

10+
Peer-reviewed publicationsAbstracts and posters at the field's most competitive venues, across Phase I immuno-oncology programs
ASCO SITC AACR Phase I IO · 2023–2024

"An unusually high scientific footprint for an executive whose primary role is clinical operations."

Professional Experience

The career in full

2022 – 2026
Indaptus Therapeutics
Vice President,
Clinical Operations

Built and led the clinical operations function for a clinical-stage immuno-oncology biotech — establishing the entire infrastructure from scratch while overseeing a Phase I/II program through dose escalation and expansion.

  • Pharm.D. Scientific Operator: Co-authored 10+ peer-reviewed abstracts at ASCO, SITC, and AACR (2023–2024) — elevating program credibility with global KOLs and demonstrating scientific depth rare in an ops executive.
  • Infrastructure Buildout: Established SOPs, CRO vendor framework, and TMF architecture enabling rapid site activation for a first-in-class IO asset; chaired cross-functional oversight committee spanning Clinical Development, Preclinical, CMC, and Regulatory.
  • Budget & Vendor Oversight: Directed CRO selection and performance management; oversaw clinical trial material forecasting and full study budget across multi-year execution in a resource-constrained environment.
2021 – 2022
Ayala Pharmaceuticals
Executive Director,
Clinical Operations

Led global clinical operations for a Precision Medicine-focused oncology biotech targeting a rare disease indication — where a narrow biomarker-selected patient population demanded a sophisticated multinational site strategy.

  • Rare Disease Enrollment: Engineered site feasibility and biomarker-selected recruitment for adenoid cystic carcinoma, navigating the global specialist-center landscape to make multinational patient accrual viable.
  • Risk Management: Maintained deliverables and cost targets through proactive identification and resolution of CRO, supply chain, and regulatory risks in a resource-constrained environment.
  • Cross-Functional Execution: Aligned Regulatory Affairs, CMC, and PM around a unified execution roadmap — improving handoff efficiency and reducing cycle time on key deliverables.
2015 – 2020
Horizon Therapeutics
Senior Director, Clinical
Development & Operations

Directed simultaneous programs across immuno-oncology, orphan disease, and rheumatology — one of the broadest multi-indication portfolios managed by a single ops leader at the company over a five-year tenure.

  • Multi-Indication Portfolio: Oversaw concurrent trials across 3 therapeutic areas, ensuring all programs met ICH/GCP standards and clinical development plan milestones throughout a five-year tenure.
  • Regulatory Authorship: Contributed to IND, NDA/BLA, and MAA submissions — authoring protocols, Investigator Brochures, and interim study reports advancing multiple assets toward approval.
  • Contract Execution: Negotiated all CRO and vendor contracts; administered trial budgets in partnership with legal — consistently on scope and cost across a multi-year, multi-program portfolio.
2014 – 2015
Astellas Pharma
Director,
Global Study Management

Hand-selected to lead strategic lifecycle planning for two of the three highest-priority global oncology compounds, managing a 14-person team across design, execution, and evaluation.

  • Portfolio Priority: Led lifecycle strategy for the #1 and #2 oncology compounds in Astellas' global R&D pipeline; directly managed 14 clinical study staff across cross-regional teams.
2012 – 2014
Celgene Corporation
Associate Director,
Clinical Operations

Global Clinical Operations lead for the Hematology/Oncology portfolio — 8 compounds, 20 concurrent studies, $180M in programmatic assets.

  • Portfolio Scale: Administered $180M across 8 compounds and 20 studies; mentored 8 Senior Study Managers across 3 regional offices, driving global consistency in execution and quality standards.
  • Speed to Activation: Opened 3 studies for patient accrual within 9 weeks of final protocol delivery — compressing a milestone that typically requires 4–6 months.

Earlier Career

TGen

Divisional Deputy Director — bench-to-bedside translational oncology research; Stand Up 2 Cancer grant recipient.

Baxter Healthcare

Associate Director, Clinical Development — Medical Affairs lead for Anti-infective and Oncology; IND submissions.

US Oncology

Director, Translational Oncology — Phase I/II business development; national physician research network.

NeoPharm · Pharmacia

Sr. Director & Clinical Research Manager — 4 proprietary oncology products; pivotal Phase III global trials.

Complete career history available upon request.

Credentials

Education & affiliations

Doctor of Pharmacy (Pharm.D.)
University of Illinois  ·  Chicago, IL
Bachelor of Science (B.S.)
Indiana University  ·  Bloomington, IN
ASCODIAASHPHOPA

Resume

One page.
Everything that matters.

Formatted for executives and search firms.
Full career detail on the Experience page.