Associate Director/Director of Clinical Development

Location
San Francisco, California
Posted
Oct 19, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
About Calcilytix & BridgeBio Pharma

Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, is developing CLTX-305 (encaleret), a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (a genetic cause of hypoparathyroidism due to gain-of-function mutations in CaSR). Encaleret is currently being evaluated in a Phase 2 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, 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.

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

Who You Are:

This individual will be responsible for developing and executing clinical development programs for Calcilytix Therapeutics, including the leadership of the pivotal trials, NDA, and filing activities for the lead program in ATTR. The individual will lead and provide strategic direction to the cross-functional clinical teams, focusing on the ATTR Cardiomyopathy program. This position will serve as a key liaison between the company and clinical investigators and establish credible relationships between Calcilytix and leaders in the field.

Responsibilities:
  • Own all clinical research planning, documentation, and communication
  • Lead the cross-functional development team from the clinical and scientific perspective towards accomplishing corporate goals
  • Design scientifically rigorous, operationally feasible, and cost-effective clinical study protocols that form the substantive basis of the CLTX-305 Clinical Development Plan
  • Lead the development team in the conceptual basis for clinical data collection, review, and interpretation, including oversight of CRF design elements, database design, data management plans, and biostatistics and data analysis, data review, reporting with support from Clinical Operations, Data Management, and Stats & Programming
  • Own the clinical research contributions sections of regulatory submission documents, including amendments to INDs, Briefing Documents, the medical and scientific content of regulatory correspondence, NDA/MAA submissions, safety reports and updates, and annual reports (DSUR/PSUR)
  • Provide clinical interpretation and integration of pre-clinical and early clinical findings into the evolving product development plan and TPP while working to ensure cross-functional alignment on an ongoing basis
  • Serve as lead Medical Monitor responsible for oversight of other clinical research personnel, including CRO Medical Monitors supporting the process from protocol development and amendments through study execution to completion of clinical study reports and integrated regulatory summary documents
  • Monitor study progress to ensure proper study conduct and adherence to clinical study protocols, company policies, SOPs, and GCP
  • Monitor Study Performance and Quality Metrics in collaboration with Clinical Operations and Data Management
  • Take a leadership role in study team meetings and those with external vendors/partners
  • Provide support to Clinical Operations in relevant aspects of study execution (e.g., patient recruitment);
  • Present study updates, interim results, and final headline data to senior management as required
  • Support Business Development for both potential licensing opportunities and collaborations
  • Be consistently patient-focused with a deep commitment to understanding the needs and improving the lives of patients through a passion for developing novel therapeutics
  • Be consistently motivated to work in a fast-paced, highly accountable, small company environment through a "can do" attitude as a collaborative, collegial professional who leads through influence and interpersonal skills
  • Consistently demonstrate the capability of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
  • Demonstrate leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment
  • Reliably communicate clearly and effectively in writing, oral discussion, and public presentation
  • Lead the development of written reports and representations of the scientific program data toward the development of scientific publications and presentations
  • Have solid critical, strategic, and analytical thinking skills
  • Continue to develop subject-matter medical expertise in conditions understudy
  • 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 towards 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:
  • 3+ years of Clinical Development experience preferred in biopharmaceutical sponsored clinical research and/or drug development (biopharma, CRO, or other industry environments)
  • MD degree or equivalent, specialty or subspecialty training preferred


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


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.