Vice President, Biometrics

Dispatch Biotherapeutics, Inc.; San Francisco (CA); Sur place; USD 280 000 - 355 000; Plein temps

Avantages offerts par ce poste

Equity

Medical coverage

Vision & Dental

401(k) plan

Life insurance

Flexible PTO

Additional substantial benefits

Résumé du poste

Dispatch Biotherapeutics, Inc. is seeking a Vice President, Biometrics to establish and lead our Biometrics function as we enter the clinic.

Reporting to the CMO, you will define how biostatistics, programming and data management are done, while hands-on contributing to analyses for first-in-human studies. You will select and oversee CROs and vendors, partner with cross-functional teams, ensure regulatory readiness, and scale the function as our pipeline grows.

Qualifications

• PhD in Statistics or Biostatistics required.
• Minimum 15 years in clinical development statistics with leadership.
• Significant oncology experience and endpoints familiarity.
• Experience with regulatory submissions (IND, BLA/MAA).
• Proficiency in SAS and/or R and data management.
• Strong cross-functional collaboration and leadership.

Responsabilités

• Build biometrics function from the ground up with scalable SOPs and standards.
• Serve as hands-on lead statistician for ongoing first-in-human study.
• Provide statistical leadership on early-phase design and dose strategies.
• Interpret safety/efficacy data to inform program decisions.
• Oversee CROs and vendors and manage budgets.
• Collaborate with regulatory affairs for submissions and regulatory readiness.
• Scale the function for multi-program, multi-region portfolio.

Connaissances

PhD in Statistics

15+ years clinical stats

Oncology experience

FDA regulatory submissions

SAS and/or R

Leadership experience

CDISC SDTM/ADaM

ICH guidelines (E9)

CRO/vendor management

Bayesian methods

Formation

PhD in Statistics/Biostatistics or related field

Outils

SAS

R

Description du poste

About us:

Our purpose at Dispatch is to help create a world where all cancer patients can be cured. We’re humbled by the opportunity to work together as a team on some of the most pressing medical challenges of our time.

To achieve our purpose, we are dedicated to engineering a universal treatment across solid tumors. We’re committed to the development of novel therapies, leveraging first-in-class technologies in viral vectors, universal targets, and novel cytokine biology. Our therapeutic approach has the potential to enable us to treat significant numbers of cancer patients and make a real and lasting impact on the world.

Our company was founded on pioneering work carried out in the laboratories of Dr. Carl June (University of Pennsylvania), Dr. Kole Roybal (University of California, San Francisco), Dr. Christopher Garcia (Stanford University) and Dr. Andy Minn (Memorial Sloan Kettering Cancer Center).

At our company, you would become one of our early team members— not only playing a role in meeting our ambitious mission but also building our thriving culture. We are determined to deliver with urgency to discover new solutions and we always stay dedicated to scientific rigor; we have an ownership mindset because each and every one of us is integral to our success. Collaboration is core for us because we believe that by bringing people together with diverse perspectives, we make a stronger whole. And, we show we care about our work and each other by sharing feedback - ultimately in service of our vision to empower people to continue forward with their lives – cancer free.

The role:

Dispatch is seeking a Vice President, Biometrics to establish and lead our Biometrics function as we enter the clinic. Reporting to our Chief Medical Officer, you will be one of the first members of our Development team, joining shortly after the start of our first clinical study. This is a builder’s role: our biometrics strategy, standards, processes and vendor model are still taking shape, and you will define how biostatistics, statistical programming and clinical data management are done at Dispatch — while rolling up your sleeves to do much of the work yourself. You will not inherit a large team but rather we are looking for a hands‑on leader who is energized by building something from the ground up and scaling it thoughtfully as our pipeline grows.

You will be the statistical voice of our development strategy, ensuring scientific rigor in how we design studies, select doses, interpret emerging data and make program decisions. Your closest partners will be the VP Regulatory Affairs, VP Clinical Operations and VP Clinical Development, and you will work as a core member of cross‑functional program teams alongside the Head of Program and Portfolio Management and our Product Team Leads, as well as colleagues in Translational Science, Research and Technical Operations. Externally, you will select and oversee CROs, functional service providers, data management vendors and statistical consultants, and support interactions with regulators, independent safety and data monitoring committees, investigators, investors and partners.

Key responsibilities:

• Build the biometrics function from the ground up, including the strategy, operating model (in‑house versus outsourced), SOPs, data standards (e.g., CDISC SDTM/ADaM), templates and analysis infrastructure — right‑sized to our stage and designed to scale
• Serve as the hands‑on lead statistician for our ongoing first‑in‑human study: author and review statistical sections of protocols, statistical analysis plans, TLF specifications and data review plans, and perform or QC key analyses
• Provide statistical leadership on early‑phase design, including dose‑escalation and dose‑expansion strategies, model‑based and Bayesian dose‑finding methods, two‑stage and single‑arm designs with efficacy/futility boundaries, and dose optimization consistent with current FDA and global health authority expectations
• Drive timely, rigorous interpretation of emerging safety and efficacy data (e.g., ORR, duration of response, PFS, OS) to inform safety review committees, interim analyses and program go/no‑go decisions
• Partner with Clinical Development and Program and Portfolio Management on clinical development plans and target product profiles, contributing sample size, probability‑of‑success and scenario analyses to evaluate potential paths to registration
• Partner closely with the VP Regulatory Affairs to lead the statistical content of regulatory interactions and submissions, including briefing documents, IND amendments, annual reports/DSURs, end‑of‑phase meetings and expedited program requests, and plan ahead for integrated analyses and BLA readiness
• Oversee clinical data management in partnership with Clinical Operations, including EDC build, data quality and cleaning strategies, data review and database lock, ensuring data integrity and inspection readiness
• Select, contract and manage CROs and biometrics vendors, holding them accountable for quality, timelines and budget
• Collaborate with Translational Science to integrate biomarker, pharmacokinetic/cellular kinetic and exploratory data into analyses that deepen our understanding of mechanism and patient response
• Evaluate and apply innovative methods where they add value, such as artificial intelligence and machine learning applications, external control and real‑world data approaches to contextualize single‑arm results
• Ensure the accuracy and appropriate statistical framing of external data communications, including congress abstracts, presentations and publications, as well as data shared with potential partners and investors
• Scale the function as we evolve toward a multi‑program, multi‑region clinical portfolio, hiring thoughtfully and developing team members as the needs of the business grow

Required experience & skills:

• Ph.D. in Statistics, Biostatistics or a related quantitative field
• At least 15 years of experience in clinical development statistics within the biopharmaceutical industry, with progressive leadership responsibility, including leading a biostatistics or biometrics function or serving as the lead statistician across multiple programs
• Substantial hands‑on oncology experience, including design and analysis of early‑phase oncology studies and familiarity with oncology endpoints and response criteria (e.g., RECIST, time‑to‑event endpoints)
• Demonstrated expertise in innovative early‑phase designs, including dose‑escalation and dose‑expansion approaches
• Direct experience leading statistical contributions to FDA interactions and regulatory submissions (e.g., IND, end‑of‑phase meetings); contribution to at least one BLA/NDA/MAA
• Strong working knowledge of ICH guidelines (including E9/E9(R1)), GCP, CDISC standards and relevant FDA guidance
• Proven track record of selecting and overseeing CROs and functional service providers in an outsourced operating model
• Hands‑on proficiency in SAS and/or R, and willingness to personally perform and QC analyses
• Comfort operating as a leader with a small team (but with no team at first) and a strong desire to build
• Collaborative nature, geared toward cross‑functional teamwork; able to influence peers and leaders without relying on hierarchy
• Excellent organizational, problem‑solving and time management skills, with the judgment to manage competing priorities
• Positive attitude, dedicated work ethic and flexible orientation for operating in a fast‑paced, entrepreneurial environment where processes are still being built
• Strong verbal and written communication skills, including the ability to translate complex technical concepts for clinical, scientific, executive and external audiences
• Comfortable giving and inviting candid feedback, and flagging risks early, before key decisions are made

Preferred experience & skills:

• Experience with cell therapy (e.g., CAR T) or gene therapy programs, including analysis of cellular kinetics and immune‑related safety events such as CRS and ICANS
• Experience in oncology, especially solid tumors and particularly gastrointestinal cancers
• Experience supporting expedited regulatory pathways, including Breakthrough Therapy designation and accelerated approval based on single‑arm studies
• Experience with Bayesian methods, external control arms or real‑world evidence in a regulatory context
• Prior experience as the first or founding biometrics leader at an early‑stage biotech
• Experience supporting ex‑US clinical studies
• Experience supporting business development diligence, financing or IPO‑related data activities

Base Salary Range: $280-355K

Our values:

Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.

Determined to deliver:

By working with focus and passion, we can provide patients with the solutions they need.

Own every outcome:

We can reach new heights when we stay centered on our shared success.

Collaboration at the core:

When we band together, our work is better.

Feedback is fundamental:

Constructive and authentic positive feedback may be difficult to master but it is vital to our success.

Working here:

• We offer a highly competitive compensation package with meaningful ownership through equity
• Excellent coverage for medical, vision, and dental
• 401(k) with generous contribution
• Life insurance
• Flexible PTO policy
• Additional substantial benefits

We are an equal opportunity employer.

We do not discriminate on the basis of race, religion, gender, sexual orientation, age, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.