Clinical Development Clinical Science Medical Monitoring Program & Portfolio Leadership

Clarity
Forward.

Turning complex development challenges into aligned, actionable strategy.

Oncology drug-development and program leader with 25+ years across the full lifecycle — first-in-human to approval. I connect clinical science, operations, regulatory, and portfolio execution, and build the decision-support tools that make that work verifiable.

Start a conversation → See selected impact
Portrait of Jason Summa
25+
Years in oncology development
13
Peer-reviewed publications
100+
Global trial sites managed
★ 1
Breakthrough Therapy Designation
Selected Leadership Outcomes

Evidence that the work moved.

Different organizations, different development stages, one operating pattern: clarify the critical decision, align the disciplines around it, and move the program toward a defensible milestone.

Stop · Large-pharma oncology program
Tripled
Response rate, after the companion diagnostic was requalified.

Stopping enrollment to correct patient selection.

On a registrational oncology study, a companion diagnostic was misclassifying patients at enrollment. With a colleague in translational medicine, I advocated to stop enrolling—patients already on treatment stayed on drug—until the assay could be requalified. When enrollment resumed, the response rate tripled, because the right patients were finally on the study.

Patient selection · benefit-risk judgment
Build · BIND Therapeutics
18 months

From platform promise to first-in-class IND.

Led a 20-person cross-functional team through the development path for a PSMA-targeted nanoparticle oncology program.

Early development · clinical translation
Scale · Janssen Oncology
100 sites

Late-stage execution with regulatory consequence.

Managed approximately 100 global sites at 95% data-quality compliance while contributing to the niraparib prostate-cancer program and its FDA Breakthrough Therapy Designation.

Global delivery · regulatory designation
Accelerate · Promontory Therapeutics
−4 mo.

A faster start with less operational drag.

Re-engineered an oncology basket-study protocol, reducing projected start-up time by four months and program cost by 15%.

Protocol strategy · portfolio execution
Leadership Profile

A full-lifecycle operator, not a narrow specialty.

I work where clinical science and program leadership meet—connecting the evidence, the operating plan, and the people accountable for the next milestone.

Converting science into clear, executable development strategy.

On a given program I have authored the protocol, served as medical monitor and signatory, and also owned the timelines, teams, budgets, risks, and governance that carry the work forward.

My foundation spans nine years building the clinical-translational function at BIND Therapeutics, four years at Janssen Oncology across Phase II/III programs, and senior clinical-science, medical-monitoring, advisory, and program-leadership roles across emerging biotech.

I am equally comfortable in the regulatory lane—protocol, investigator-brochure and IND/CTA authorship, health-authority responses, inspection readiness, and a RAPS Foundation in Regulatory Affairs.

I came up through CMC before I ran clinical development, so the manufacturing conversation isn't a translation exercise.

01

Clinical strategy & patient safety

Phase I–III protocol leadership, medical monitoring, benefit-risk review, and clinical decision-making.

02

Program & portfolio execution

Integrated plans, governance, budgets, dependencies, and cross-functional alignment from pre-IND onward.

03

Data & regulatory integrity

Submission-ready documents, database remediation, SAP/DSUR standards, and inspection-ready oversight.

04

Teams built around the milestone

Leadership across founders, global pharma, consultants, CROs, CDMOs, investigators, and internal functions.

Clinical Development Strategy Medical Monitoring Program & Portfolio Leadership CMC / Clinical / Regulatory Integration Phase I–III Trial Oversight IND / CTA Preparation Inspection Readiness RAPS FRA
i

Why “Clarity Forward.” Caring for my mother through a rare cancer and my father through neurodegenerative disease reinforced a standard I carry into every program: in medicine, clarity is care. Behind every endpoint is a family waiting for an answer.

Experience

A 25-year arc in oncology drug development.

2026
Senior Director, Head of Clinical Science · K36 Therapeutics
Led the clinical science function for NSD2-inhibitor epigenetic oncology programs — multiple myeloma and metastatic prostate.
  • Stood up and led the clinical science function for the NSD2/MMSET epigenetic oncology pipeline — the lead multiple-myeloma program and a first-in-human Phase 1 study in metastatic prostate cancer.
  • Directed end-to-end clinical database remediation for a multiple-myeloma study — restoring data integrity and inspection-readiness.
  • Established clinical data standards underpinning SAPs and DSURs; built JReview-based tools for real-time medical and safety review.
  • Led pharmacovigilance in collaboration with Bristol Myers Squibb; authored health-authority responses on the multiple-myeloma program.
  • Assessed a key competitor's registrational Phase 2 readout and its implications for program strategy.
2026
Program Management · Ellison Medical Institute
Program-management leadership advancing the Institute's lead oncology candidate toward IND.
  • Drove cross-functional program planning and execution for the Institute's first development candidate on its path to IND — coordinating R&D, preclinical, CMC, regulatory, and early clinical workstreams.
  • Built the operating rhythm for a lean team: integrated project plans, timelines, and risk/interdependency tracking, with clear status reporting to scientific founders and executive leadership.
  • Served as the primary point of operational alignment across internal teams, consultants, and CRO/CDMO partners.
  • Evaluated leading AI platforms for drug development and recommended an enterprise standard.
2025
Senior Director, Medical Monitor · TORL BioTherapeutics
Medical monitoring and clinical leadership across TORL's oncology antibody-drug-conjugate portfolio.
  • Provided medical leadership and monitoring for the CATALINA program — the registration-enabling Phase 2 (CATALINA-2) and confirmatory Phase 3 (CATALINA-3) of TORL-1-23, a first-in-class CLDN6-targeted antibody-drug conjugate in platinum-resistant ovarian cancer.
  • Served as medical lead on protocol and amendment reviews — safety and benefit-risk determination, protocol-deviation review, and clinical-quality oversight across study teams.
  • Led medical review of clinical safety and efficacy data, ensuring scientific integrity, patient safety, and inspection-readiness.
  • Partnered cross-functionally with translational, CMC, and operations teams on pre-IND / IND strategy.
2021–25
Drug Development Advisor · Summa Consulting Group
Independent advisory across preclinical through Phase III for biotech and pharma sponsors.
  • Advised sponsors including Takeda, BioNTech, Exelixis, Nimbus, Neumora, and Tarsus; delivered 30+ submission-ready projects — protocols, investigator brochures, CSRs, and IND components.
  • Reduced document review-cycle times ~30% through structured authorship and review.
  • Spanned oncology plus rare / orphan disease, immunology, infectious disease, and CNS programs.
2020–21
Vice President, Clinical Development & Operations · Promontory Therapeutics
Owned clinical development for multiple oncology and combination programs.
  • Directed clinical development and operations for multiple early- and mid-stage oncology and combination programs.
  • Re-engineered a basket-study protocol — start-up −4 months, costs −15%.
  • Led portfolio governance, KOL networks, budgets, and vendor oversight.
2016–20
Director, Clinical Development · Janssen R&D, Oncology
Co-led late-stage oncology programs through regulatory designations and approvals.
  • Contributed to the niraparib prostate-cancer program (GALAHAD, mCRPC with DNA-repair defects) and its FDA Breakthrough Therapy Designation — on the path to AKEEGA® approval.
  • Managed ~100 global sites at 95% data-quality compliance.
  • Served as clinical liaison across regulatory, translational, and commercial functions; advised at JLABS.
2007–16
Senior Director, Clinical Development & Operations · BIND Therapeutics
Nine-year anchor: built the clinical function for a PSMA-targeted nanoparticle oncology platform.
  • Built the clinical-translational framework and led clinical development of BIND-014 (PSMA-targeted docetaxel nanoparticle) through Phase 1/2 in advanced solid tumors and metastatic prostate cancer.
  • Delivered a first-in-class IND in 18 months, leading a 20-person team.
  • Helped grow the company from an MIT-rooted academic spin-out to a public clinical-stage organization; the nanoparticle platform was ultimately acquired by Pfizer. Program work published in JAMA Oncology, Clinical Cancer Research, and Science Translational Medicine.
2000–07
CMC & Program Management foundation · Momenta · Corixa · Alkermes
Early career across CMC and program management — Project Manager, PMO (Momenta); Senior Scientist, CMC (Corixa, Alkermes).
  • CMC and inhalable-formulation development at Advanced Inhalation Research / Alkermes — co-inventor on the Inhalable Epinephrine patent family.
  • Project and program management foundation (PMO) underpinning a 25-year development career.
Therapeutic Areas

Oncology at the core, with breadth across the clinic.

Twenty-five years centered on oncology drug development — extended, through advisory work, into rare disease, immunology, and beyond.

Primary focus

Oncology — pre-IND through Phase III

Solid tumors and hematologic malignancies, including antibody-drug-conjugate, nanoparticle, epigenetic (NSD2), targeted, and immuno-oncology programs — spanning clinical science, medical monitoring, and program leadership.

Indications
Multiple MyelomaMetastatic ProstateNon-Hodgkin LymphomaNSCLC (Lung)OvarianSolid Tumors
Modalities & approaches
Antibody-Drug ConjugatesNanoparticle TherapeuticsEpigenetic (NSD2)Targeted Small MoleculesImmuno-Oncology

Antibody and ADC programs whose mechanisms — including B-cell depletion — are shared with immune-mediated disease.

Broader therapeutic experience — largely through advisory work, pre-IND through Phase III
Rare & Orphan DiseaseImmunology & InflammationInfectious Disease & VaccinesCNS / NeuropsychiatricMetabolic & EndocrineRespiratoryCardiovascular / Hematology
Education & Credentials

Training across science, business, and regulatory.

2025
Foundation in Regulatory Affairs (FRA)
Regulatory Affairs Professionals Society (RAPS)
M.B.A.
Boston University · Questrom School of Business
B.Sc., Chemistry
The Pennsylvania State University

Regulatory & professional

RAPS Foundation in Regulatory Affairs (FRA), 2025 — formal grounding for the protocol, IB, IND, and health-authority work I lead day to day.

Protocol & IND authorship Medical monitoring Inspection readiness Pharmacovigilance
Publications & Talks

Peer-reviewed across the field's leading journals.

13 publications and a granted patent family in oncology drug development — selected below.

Download full list →

Peer-Reviewed Articles

Safety and Efficacy of BIND-014, a Docetaxel Nanoparticle Targeting PSMA in Metastatic Castration-Resistant Prostate Cancer: A Phase 2 Clinical Trial
Autio KA, Dreicer R, … Summa JM, … Scher HI. 2018.
JAMA Oncology →
Phase I Study of PSMA-Targeted Docetaxel-Containing Nanoparticle BIND-014 in Patients with Advanced Solid Tumors
Von Hoff DD, Mita MM, … Summa JM, … Sachdev JC. 2016.
Clin. Cancer Res. →
Preclinical Development and Clinical Translation of a PSMA-Targeted Docetaxel Nanoparticle with a Differentiated Pharmacological Profile
Hrkach J, Von Hoff D, … Summa J, … Langer R, Zale S. 2012.
Sci. Transl. Med. →

Selected Conference Abstracts

Niraparib in mCRPC with biallelic DNA-repair gene defects — GALAHAD interim analysis & correlative response
ASCO · ESMO · 2019–20
BIND-014 PSMA-targeted docetaxel nanoparticle — Phase 1/2 PK, PSMA selection, and cardiovascular safety series
AACR · ASCO · 2013–16

First or contributing author across nine society abstracts. Full citation list available on request.

Patent

Inhalable Epinephrine — co-inventor (multi-jurisdiction family incl. US 7,947,742 B2; 8,415,397 B2; 8,747,813 B2; EP 1531794 B1)
Granted
Voices

What colleagues say.

Excerpts from written letters of recommendation by senior oncology leaders who know the work firsthand.

“
Without a doubt, Jason is one of the very best clinical development individuals I have ever had the opportunity to work with. He always delivers.
Daniel D. Von Hoff, MD, FACP
Physician-scientist, oncology drug development · TGen · City of Hope
“
Jason's unique blend of strategic insight, technical acumen, and collaborative spirit is very unique… I am confident he will exceed your expectations.
Anthony W. Tolcher, MD
CEO & Founder, NEXT Oncology
“
Within a short time of starting with us, he provided insights, recommendations and contacts from within his professional network that to this day maintain a recognizable positive impact on our program… I would urge your organization to consider his candidacy seriously.
Matthew R. Price
EVP & COO, Promontory Therapeutics
Insights

A point of view shaped by the work.

Perspectives on oncology development, program leadership, and making consequential decisions under uncertainty.

Featured insight

From Early Oncology Signal to a Decision-Ready Development Strategy

Early evidence becomes strategy only when a team is explicit about what it knows, what it assumes, and what decision comes next.

A promising signal can create momentum before it creates clarity. The leadership task is to turn incomplete evidence into a disciplined next decision—without overstating certainty or slowing the program into paralysis.

Read the full insight
Clinical operations

The Clinical Development Plan Is Only as Strong as Its Operational Assumptions

Operational feasibility is not downstream from oncology development strategy. It determines whether a trial can produce an interpretable answer.

Read the full insight
Program & portfolio leadership

Portfolio Governance Should Produce Decisions, Not Updates

Governance creates value when it turns complex program evidence into explicit choices, accountable decisions, and a clear path forward.

Read the full insight
Clinical science & patient safety

Medical Monitoring Is a Development Leadership Function

Effective oncology medical monitoring connects patient-level judgment to protocol intent, emerging evidence, and the program’s next decision.

Read the full insight
Program recovery

Recovering an Oncology Program Starts with the Decision System

When an oncology program loses momentum, recovery begins by making the evidence, ownership, and critical path explicit.

Read the full insight
View all Insights
Applied AI · Selected Product Work

Built for the decisions clinical teams actually face.

I build these because clinical teams keep making the same decisions without the right instrument in front of them. They are a byproduct of the development work, not a pivot away from it.

I translate domain problems into working decision-support software: deterministic where the answer must be reproducible, AI-assisted where interpretation adds value, and designed around human review. These are independent capability demonstrations—not sponsor systems or production medical software.

Clinical workflow first Reproducible engines Traceable outputs Private by design
Precis interface checking draft figures against a source table and flagging a mismatch
Precis
Regulatory writing · QC

Every number traced to its source.

Checks regulatory drafts against source tables and CDISC datasets, classifies figures as verified, mismatched, or unsourced, and preserves a click-through audit trail. The engine never rewrites a number or invents one.

  • Source traceability
  • CDISC-aware
  • Validation pack
Independent applicationDemonstration available
Response interface showing a longitudinal RECIST assessment with partial response followed by progression
Response
Oncology · Response assessment

Make response over time explicit.

Walks longitudinal imaging and laboratory data across RECIST 1.1, iRECIST, IMWG, and PCWG4; identifies best response and confirmed progression; and cites the rule behind every classification.

  • Longitudinal assessment
  • Criteria-aware
  • Cited decisions
Independent applicationDemonstration available
TrialPath interface showing a clinical trial critical path, projected milestones, and enrollment forecast
TrialPath
Program leadership · Trial planning

See what actually drives the readout date.

Connects phase dependencies, site activation, screening, enrollment, follow-up, database lock, and readout on one critical path—then models milestone uncertainty instead of presenting a single optimistic date.

  • Critical path
  • Enrollment forecast
  • Scenario planning
Independent applicationDemonstration available
Depot interface showing clinical supply inventory, expiry risk, stock-out timing, and a dated action calendar
Depot
Clinical operations · Supply

Turn supply risk into a dated action plan.

Forecasts investigational-product demand, tracks FEFO coverage and expiry exposure, simulates uncertainty, and identifies the first stock-out. The output is an operational handoff: what to order, how much, and by when.

  • Monte Carlo
  • FEFO coverage
  • Action calendar
Independent applicationDemonstration available

All interfaces shown with synthetic or built-in example data. Tools were built independently as capability demonstrations; no confidential, patient, or sponsor data is used. Walkthroughs are available on request.

The Next Chapter

One leadership identity. Two ways to engage.

I am considering the right senior full-time leadership opportunity and, selectively, focused advisory engagements where experienced judgment can move a program forward.

Roles I'm targeting: Executive Director or Senior Director in Clinical Development, Clinical Science, Program & Portfolio Management, or Alliance Management.

Based in Los Angeles Open to relocation, travel, and remote opportunities
Primary path · Full-time

Senior leadership

For organizations seeking an experienced leader who can connect clinical strategy, scientific judgment, operational execution, and the portfolio decisions behind a consequential development program.

Clinical developmentClinical scienceMedical monitoringProgram & portfolio leadership
Discuss a leadership opportunity →
Select engagements · Advisory

Focused advisory work

Senior-level support for a defined decision, inflection point, or recovery effort—with a clear mandate, disciplined scope, and practical deliverables.

Development strategyProtocol & portfolio reviewProgram recoveryOperational readinessResponsible AI enablement
Discuss an advisory engagement →

Or book time directly

Get in Touch

Start with the challenge.

If there may be a fit, let's compare notes. I share a tailored executive CV directly, with the experience and context most relevant to the opportunity.

Request my executive CV → Email me