Senior Director, Regulatory Affairs San Francisco, CA/Hybrid
Company: BridgeBio Pharma
Location: San Francisco
Posted on: March 20, 2023
Job Description:
About QED Therapeutics & BridgeBio Pharma QED Therapeutics, an
affiliate of BridgeBio Pharma, focuses on precision medicine for
FGFR-driven cancers and diseases. The company's first therapy,
TRUSELTIQ (infigratinib), is an orally administered FGFR1-3
tyrosine kinase inhibitor that the US FDA recently approved to
treat patients with previously treated locally advanced or
metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or
rearrangement. We are also evaluating infigratinib for the
treatment of other FGFR-driven cancers and the treatment of
achondroplasia and other skeletal dysplasias. QED is derived from
the Latin "Quod Erat Demonstrandum" -Thus; It Has Been Proven. Our
business is inspired by our values: PUT PATIENTS FIRST EVERY MINUTE
COUNTS THINK INDEPENDENTLY BE RADICALLY TRANSPARENT FGFR=fibroblast
growth factor receptor. BridgeBio is a biopharmaceutical company
founded to discover, create, test, and deliver transformative
medicines to treat patients who suffer from genetic diseases and
cancers with clear genetic drivers. We bridge the gap between
remarkable advancements in genetic science in academic institutions
and the delivery of meaningful medicines to patients. Founded in
2015, the company has built a portfolio of 30+ drug development
programs ranging from preclinical to late-stage development in
multiple therapeutic areas including genetic dermatology, precision
oncology, cardiology, endocrinology, neurology, pulmonology, and
renal disease, with two approved drugs. Our focus on scientific
excellence and rapid execution aims to translate today's
discoveries into tomorrow's medicines. We have U.S. offices in San
Francisco, Palo Alto, Boston, New York, and Raleigh, with small
satellites in other parts of the country. We also have
international offices in Montreal, Canada, and Zug, Switzerland,
and are expanding across Europe. The Senior Director, Regulatory
Affairs, will drive global regulatory strategies and
responsibilities across select BridgeBio Affiliate companies to
successfully advance assets in succinct timelines. Responsibilities
include developing and implementing regulatory strategies,
interfacing with regulatory agencies, identifying and managing
regulatory risks, implementing the regulatory aspects of clinical
trials, and developing and submitting regulatory documents. This
role will serve as the primary point of contact for regulatory
agencies globally, with responsibility for regulatory agency
submissions, action items, and communications worldwide on assigned
programs. Responsibilities
- Lead the creation and execution of proactive regulatory
strategies for product development, approval, and registration
- Apply knowledge of global quality/regulatory standards and
guidelines to ensure requirements are met across programs
- Partner with internal senior leadership to align closely on
cross-functional global regulatory plans and the company's short
and long-term strategic objectives
- Lead regulatory submission deliverables
- Prepare and implement critical global regulatory submissions
(from pre-IND to post-marketing) to the FDA, EMA, and other
international health authorities
- Develop and present regulatory strategies, recommendations, and
risks during senior management discussions
- Lead the specific Affiliate regulatory strategy team by
managing, mentoring, and teaching capabilities
- Work at both high-level strategic and hands-on in leading an
agile team No matter your role at BridgeBio, successful team
members are:
- Patient Champions, who put patients first and uphold strict
ethical standards
- Entrepreneurial Operators, who drive toward practical solutions
and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem
solvers
- Individuals Who Inspire Excellence in themselves and those
around them
- High-quality executors, who execute against goals and
milestones with quality, precision, and speed Education, Experience
& Skills Requirements
- Bachelor's degree in the scientific field is required; an
advanced degree (MD, Ph.D., PharmD, MS) is preferred
- A minimum of 10+ years of relevant pharmaceutical/biotechnology
regulatory affairs experience in the pharmaceutical industry,
including experience managing matrixed teams
- Well-versed in the drug development process and regulatory
requirements, as well as a good understanding of the underlying
science
- Strong attention to detail
- Excellent written and verbal skills
- Excellent project management skills, with the ability to manage
multiple projects and prioritize appropriately
- Ability to rapidly understand & analyze complex
problems/situations
- Ability to lead teams under tight timelines and be willing to
contribute significantly to day-to-day operations as needed
- Comfort in a team environment
- Strong interpersonal skills and the ability to effectively work
with others
- Ability to influence without authority, lead change, and manage
resistance to change
- Ability to solicit information, persuade others, and shape
outcomes
- Experience working with all levels of management and consulting
with key business stakeholders (internal and external) What We
Offer
- Patient Days, where we are fortunate to hear directly from
individuals living with the conditions we are seeking to impact
throughout the year and learn how we can improve our efforts
- A culture inspired by our values: put patients first, think
independently, be radically transparent, every minute counts, and
let the science speak
- An unyielding commitment to always putting patients first.
Learn more about how we do this here
- A de-centralized model that enables our program teams to focus
on advancing science and helping patients. Our affiliate structure
is designed to eliminate bureaucracy and put decision-making power
in the hands of those closest to the science
- A place where you own the vision - both for your program and
your own career path
- A collaborative, fast-paced, data-driven environment where we
inspire ourselves and each other to always perform at the top of
our game
- Access to learning and development resources to help you get in
the best professional shape of your life
- Robust and market competitive compensation & benefits package
(Base, Performance Bonus, Equity, health, welfare & retirement
programs)
- Flexible PTO
- Rapid career advancement for strong performers
- Potential ability to work on multiple BridgeBio Pharma programs
across multiple therapeutic areas over time
- Partnerships with leading institutions
- Commitment to Diversity, Equity & Inclusion - with initiatives
like Women at Bridge, we are committed to fostering an inclusive
environment where every person feels seen, valued, and heard To
view San Francisco County's Fair Chance Ordinance, please click
here .
Keywords: BridgeBio Pharma, San Francisco , Senior Director, Regulatory Affairs San Francisco, CA/Hybrid, Executive , San Francisco, California
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