senior vice president or vice president, global regulatory affairs - Oklahoma City, United States - ACIP

Description

Nanobiotix – a brief history
Est.

2003, Nanobiotix is a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform cancer treatment.

Headquartered in Paris (c.70 staff) and with a US affiliate in Cambridge, MA (c.20 staff),
Nanobiotix designs and manufactures nanoparticles that safely enhance the efficacy of radiation
therapy. With this approach, their ambition is to benefit millions of patients who receive
radiation therapy by improving the efficiency of radiation in tumor cells without increasing the
dose received by surrounding healthy tissues. Their belief is that radiotherapy combined with
NBTXR3 can become a new standard of care in the treatment of cancer.
Nanobiotix first received authorization to start the pilot phase I/II clinical study in humans in
2011, when they began also the treatment of the first patient. Filing of the CE Marking
Application for NBTXR3 in Soft Tissue Sarcoma came in 2017, followed by positive phase II/III
results for NBTXR3 in Soft Tissue Sarcoma. European market approval for NBTXR3 in this
indication was achieved in 2019 however, Nanobiotix Investors made the strategic decision to
place commercialization strategies 'on hold' and to instead, accelerate the global development of
NBTXR3 for 'head and neck', i.e. as a drug, both in Europe and the US.
Nanobiotix were publicly listed on the Nasdaq stock exchange in 2020 – a total raise of
S$113.3million.
Nanobiotix – NBTXR3 Mode of Action
NBTXR3 is being evaluated both as a single agent activated by radiotherapy alone, and as a
combination product with other anti-cancer therapies including chemotherapy and immune
checkpoint inhibitors. Once injected into the tumor, nanoparticles developed by Nanobiotix are
designed to accumulate in cancer cells in clusters while remaining inert thanks to their specific
size and their negatively-charged particular coating.
The principle of action is based on the interaction of the high electron density nanoparticles and
ionizing radiation (e.g. radiotherapy) to locally generate photons and secondary electrons within
the cell and subsequent radical production. The energy released from these clusters of
nanoparticles constitutes a dose deposit "hotspot," which should lead to high, localized
destruction of biological subcellular structures and increased cell death.
Ionizing radiation can be applied to the nanoparticles repeatedly because they return to their
inactive, inert state after each exposure to radiation. Multiple courses of radiotherapy can be
administered to a tumor that has received a single injection of the nanoparticles.
In preclinical studies, the radiation-activated nanoparticles have also been observed to trigger
metastatic cell destruction due to immunogenic cell death, leading to activation of the immune
system. Based on these observations Nanobiotix believe that their nanoparticles may prime the
body's immune response, rendering tumors more prone to recognition by a patient's immune
system.
Nanobiotix have launched multiple Phase I/II trials including a large clinical collaboration with
MD Anderson Cancer Center for 9 clinicals trials in six cancers types (head and neck, pancreatic,
thoracic, lung, gastrointestinal and genitourinary cancers).
In 2020 they were granted Fast Track designation by the FDA for investigation of NBTXR3 in head
and neck cancer. Phase I results were particularly positive, such that fast-track designation was
granted. In November 2021 Nanobiotix began its global phase III registration study for NBTXR3 in
'head and neck', in the US. In partnership with a global CRO, recruitment of patients shall be
taking place at 110 sites.
MD Anderson Cancer Center are helping with the expansion of use of NBTXR3 in other immuno-oncology indications. Following previously reported preliminary data demonstrating the ability of
the NBTXR3 to help transform anti-PD-1 non-responders into responders, Nanobiotix is
expanding its immuno-oncology phase I basket study evaluating its product in combination with
anti-PD-1 checkpoint inhibitors. A proposed protocol pathway for immuno-oncology will be
finalised and submitted to the FDA during quarter With phase III clinical trials for NBTXR3 in 'head and neck' now underway, Nanobiotix have
reached a point in its inflection where the appointment of a Global Head of Regulatory Affairs is
required at SVP or VP level, i.e. a highly visible core member of the Strategic Leadership Team
who raises the profile of function internally.
Reporting to the CEO the SVP/VP Global Regulatory Affairs drives the articulation and
implementation of a Global regulatory strategy with an emphasis on US and EU, management of
resources, regulatory timelines, representation with regulatory authorities, regulatory
compliance, and adherence to guidelines throughout the development and regulatory life cycle.
(S)he is a strategic partner to the CEO on designing, articulating, and shaping global regulatory
strategy. Required is a 'thought partner', someone who contributes beyond their functional area
of expertise to educate and to develop capabilities across R&D. This includes wider cultural
questions, such as helping employees understand 'what is at stake' (i.e. for a biotechnology
company that is running global phase III clinical trials), and on what is needed to be done to build
a successful oncology company.
In the short-to-mid term the SVP/VP Global Regulatory Affairs primary focus shall be the
evaluation of trials currently underway, so as to devise a global regulatory strategy for
Nanobiotix. In addition, to oversee the implementation of the phase III programme, including the
anticipation of requirements for inspections.
*For candidates of appropriate skills/experience the role may be broadened to include management
of QA

JOB DESCRIPTION

Key responsibilities:

• Develop the overall US and ROW regulatory strategy for development programs
• Lead and manage health authority relationships, communications, and negotiations
• Maintain current CE Mark in EU
• Provide strategic regulatory leadership, guidance, and training for all clinical development

projects to staff, both direct and in-direct, and interface with key stakeholders

• Lead regulatory risk assessment and mitigation
• Lead the regulatory function on cross functional development teams and ensure that all are

appropriately informed of US, EU, and other regulatory requirements

• Ensure that all components of manufacturing and quality programs relevant to the CMC

components are aligned to meet US, EU, and other regulatory requirements

• Manage and communicate regulatory expectations to vendors (CROs, CMOs, consultants,

etc.) to ensure compliance and regulatory strategy alignment

• Plan, participate in, and review submissions to regulatory authorities including FDA, EU and

other health authorities (IND, CTA, NDA, MAA, etc.) throughout the lifecycle of company
portfolio and ensure accuracy, and provide sign-off on all documents presented to
regulatory agencies

• Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings,

and interface with regulatory authorities, in addition to responding to requests for
information

• Provide interpretation of and advice regarding regulations, directives, and guidance
• Hire, train, and manage regulatory affairs department (currently six staff)

CANDIDATE SPECIFICATION

Essential:

• Extensive senior level experience in regulatory affairs

-18+ years of industry experience; 15+ years specifically focused in regulatory affairs

• People management experience
• Experience with having led the regulatory aspects of an oncology product, through

development to successful registration, either in the US or Europe

• Knowledge of US FDA drug regulations
• Experience with FDA, MDR, and ICH guidelines both strategically and operationally including

formal interactions with regulatory agencies

• Experience leading regulatory aspects of late stage drug development through to market
• Demonstrated experience and expertise in preparing complex regulatory documents

including INDs, NDAs, and other major regulatory submissions

• Regulatory Affairs certification (RAC) in US and EU (strongly preferred)

Preferred:

• Experience of interacting directly with the FDA, i.

e. leading discussions and articulating
complex concepts

• Large pharma and biotechnology company experience
• Experience with first in class drugs
• Experience with injectables
• Understanding of EU device regulations
• Advanced degree

Important Attributes:

• Proven leadership skills in a growing global company environment
• Entrepreneurial, with a willingness to challenge the status quo
• Strong interpersonal skills to quickly gain confidence both with internal stakeholders and

externally among regulatory agencies

• Able to contribute beyond their functional expertise to build a successful oncology company

Ability to manage relationships at the highest levels with health authorities, navigating
complex regulatory components

• Creative and agile with a hands on approach
• Able to work with some level of ambiguity, i.

e. an environment where SOPs are being created
on an ongoing basis

• Driven by a need to help all patients who may benefit from Nanobiotix's technology and

approach

• Interested in the greater good of assisting patients in need

TERMS & CONDITIONS OF EMPLOYMENT
The salary and terms of employment will be discussed in detail at an appropriate stage of an
interview with Nanobiotix. The following should serve as a guide only

• Competitive base salary
• Performance related bonus
• Relocation assistance, where required

SENIOR VICE PRESIDENT OR VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS
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