Senior Manager, Project Management

About Calcilytix & BridgeBio Pharma

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 evaluated in a Phase 3 clinical 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.

To learn more about our story and company culture, visit us at https://calcilytix.com/ | https://bridgebio.com

Who You Are

The Senior Manager, Project Management, Non-Clinical, will provide operational support for non-clinical development activities (CMC) including supporting cross-functional plans and activities across the company. The Senior Manager, Project Management will report to the Director, Project 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 (<10%) amount of travel as appropriate

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

• Partnerships with leading institutions

• Commitment to Diversity, Equity & Inclusion