Senior Manager, CMC Project Management San Francisco, CA/Hybrid
1 month ago
Calcilytix Therapeutics , an affiliate of BridgeBio Pharma, is developing encaleret (CLTX-305), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1), a genetic cause of hypoparathyroidism. Encaleret is currently being evaluatedinaPhase 3clinical study and has received Orphan Drug and Fast Track Designations from the US FDA.
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, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.
The
Senior Manager, Pro
ject
Management, Non-Clinical
, will provide operational support for non-clinical development activities
(
CMC) including supporting cross-functional plans and activities across the company. The
Sen
i
or Manag
e
r, Pro
ject
Management will report to the
Directo
r
, Pro
ject
Management,
and support the CMC/non-clinical team to ensure that cross-functional planning is incorporated in the non-clinical department activities,
identified
risks, mitigation plans are
established
to address the risks, and resource needs are
identified
and addressed proactively. In addition, the successful candidate must communicate effectively with internal stakeholders and external partners.
Responsibilities
Organize and coordinate non-clinical (CMC, Supply Chain) team activities and deliverables; manage weekly team meetings; prepare agendas and keep track of action items
Manage multiple CMOs to drive manufacturing activities in alignment with CMC timelines and clinical supply needs
Represent the non-clinical department in cross-functional sub-teams such as study teams, IND, and NDA filing teams to ensure non-clinical deliverables are aligned with regulatory activities
Responsible for ensuring adherence to agreed-upon team goals and deliverables. Coordinate drafting of certain sections of regulatory filing (e.g., NDA, MAA) and cross-functional reviews. Organize document QC processes to ensure accuracy of the contents
Contribute to long-range planning and budgetary planning. Work with Legal and Finance departments to drive and manage vendor contracts and purchase orders
Effectively manage multiple responsibilities and deliverables concurrently
This position may require some (
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
M.S. or B.S. in chemistry, chemical engineering or equivalent preferred
A minimum of 10 years of biotech/pharma industry project management
Strongly prefer local to San Francisco, Bay Area
Demonstrated understanding of drug development is required
Experience in a functional Project Manager role in regulatory filings a plus
Solid project management and organizational skills
Strong leadership skills; negotiation skills a plus
Demonstrated ability to establish and maintain effective communications internally and with external partners
Outstanding influencing skills up, down, and across the organization, including executive/senior management
Track record of delivering in a fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient
Familiarity with risk management strategies
Ability to work strategically and independently with internal and external groups on multiple projects
Expert planning and tracking skills, able to see the big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management concerning priorities and self management
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
Commitment to Diversity, Equity & Inclusion
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
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