Job Description
Iovance Biotherapeutics aims to be the global leader in innovating, developing
and delivering tumor infiltrating lymphocyte (TIL) therapy for people with
cancer. We are pioneering a transformational approach to treating cancer by
harnessing the ability of the human immune system to recognize and attack
diverse cancer cells in each patient. The Iovance TIL platform has demonstrated
promising clinical data across multiple solid tumors. We are committed to
continuous innovation in cell therapy, including gene-edited cell therapy, which
may be a promising option for patients with cancer.
OVERVIEW
The Associate Director, Regulatory Affairs, is responsible for leading one or
more drug development programs, with specific emphasis on US and global (Ex-US)
regulatory strategy, regulatory submissions, and interaction with global
regulatory authorities including Health Canada, MHRA, EMA, Swiss Medic and TGA.
The ideal candidate must have a good understanding and experience in clinical
development strategies and health authority expectations for biologic products
with novel cell and gene therapy for oncology indications preferred. The
position reports to the Senior Director, Regulatory Affairs.
Essential Functions and Responsibilities
* Collaborates closely with functional leaders to 1) create the optimal
development path for Iovance product candidates, 2) negotiate optimal
development paths within cross-functional teams and with health authorities,
3) execute clinical-regulatory development plans on-time and while managing
all identified risks.
* Plans, manages, and creates Clinical Trial Applications, Market Applications,
and amendments.
* Ensures that submission documents and correspondence are of the highest
quality in terms of content, organization, clarity of writing, and accuracy.
* Leads cross-functional teams in developing strategic briefing packages and in
preparing for health authority meetings or interactions.
* Ensures that evolving global regulations, guidelines, and health authority
expectations, especially those related to biologics or ATMPs such as cell
therapy products, are incorporated into program decision making.
* Works within the department and with other functional areas on process
improvements.
* Must adhere to Iovance Biotherapeutics’ core values, policies, procedures,
and business ethics.
* Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- BS degree in life sciences required.
- Minimum 10 years’ experience in regulatory affairs with a Bachelor’s degree,
8 years with a Master’s degree, or 5+ years with a PhD.
- Must have experience with Cell and Gene Therapy experience.
- Late‑stage experience in oncology drug development.
- Experienced in creating and negotiating the clinical-regulatory aspects of
oncology drug development programs with health authorities, including Ex-US.
* Able to write, edit, and/or collaborate on the development of high-quality
clinical-regulatory documents, e.g., briefing books, investigator brochures,
protocols, clinical study reports, clinical summaries.
- Able to write clearly and concisely, within agreed timelines.
- Able to simultaneously manage multiple projects and submissions, with
flexibility to pivot based on new data, program changes, and/or external
influences.
- High attention to detail and accuracy.
- High organizational and planning skills.
- Able to influence and negotiate professionally at various levels within
cross-functional teams and with external partners, while maintaining positive
working relationships.
* Excellent interpersonal, verbal, and written communication skills
Preferred Education, Skills, and Knowledge
- Advanced degree preferred (MS, MPH, PharmD, PhD).
- Experienced in the creation, submission, and negotiation of market
applications preferred.
The physical demands described here represent those that an employee must meet
to perform the essential functions of this job successfully. Reasonable
accommodations may be made upon request to enable individuals to perform
essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
* Must be able to remain in a stationary position standing or sitting for
prolonged periods of time.
* Must be able to move about inside an office and exert up to 10 pounds of
force occasionally or a negligible amount of force frequently or constantly
to lift, carry, push, pull, or otherwise move objects.
* Must have visual acuity to perform activities such as: preparing and
analyzing data and figures, viewing a computer screen, and extensive reading.
* This position requires repetitive motion, substantial movements (motions) of
the wrist, hands, and/or fingers.
* Must be able to communicate with others to exchange information.
Mental: Clear and conceptual thinking ability; excellent judgment,
troubleshooting, problem-solving, analysis, and discretion; ability to manage
work-related stress; ability to manage multiple priorities simultaneously; and
ability to meet deadlines
Work Environment
This job operates in a professional or remote office environment and requires
operating standard office equipment and keyboards.
#LI-remote
The annual base salary we reasonably expect to pay is listed. Individual pay
decisions depend on various factors, such as primary work location, complexity
and responsibility of the role, job duties/requirements, and relevant education,
experience and skills.
Pay Transparency
$170,000—$200,000 USD
The statements contained in this document are intended to describe the general
nature and level of work being performed by a colleague assigned to this
description. They are not intended to constitute a comprehensive list of
functions, duties, or local variances. Management retains the discretion to add
or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work
environment. As an equal-opportunity employer, our employees and applicants will
be considered without regard to an individual’s race, color, religion, sex,
pregnancy, national origin, age, physical and mental disability, marital status,
sexual orientation, gender identity, gender expression, genetic information,
military and veteran status, and any other characteristic protected by
applicable law. If you need assistance or accommodation to apply to one of our
opportunities, please contact careers@iovance.com [careers@iovance.com].
By voluntarily providing information and clicking “Submit Application”, you
explicitly consent to the collection and use of your personal information for
the purposes described above and in our Candidate Privacy Notice
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Job Tags
Full time, Work at office, Local area, Remote work