Medical Director

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Calcilytix Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing hypoparathyroidism disorders. We are currently in clinical development with a novel, small molecule calcilytic agent that antagonizes the abnormal response of mutant calcium-sensing receptors found in a genetic form of hypoparathyroidism. Patients of all ages with this rare disorder called autosomal dominant hypocalcemia have significant unmet medical needs, and Calcilytix is committed to realizing this potentially transformative agent for these patients. The promise of this class of agents is being explored for other hypoparathyroidism disorders.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit us at https://bridgebio.com

Location

San Francisco, CA

Who You Are

Calcilytix is searching for an experienced Medical Director to provide high quality scientific and clinical knowledge to guide the strategy and execution of Calcilytix’ s clinical development plan in late-stage global study development. Working collaboratively with multi-disciplinary teams, this role is responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within Calcylitix’s portfolio to ensure the program meets the patients’ needs of Calcylitix’s business. This role will influence both internal and external audiences in a high impact, prominent role as it actively contributes to the dynamic and innovative culture within Calcylitix.  

Responsibilities

  • Participate in clinical development, planning, execution, and medical monitoring of global clinical trials, including pediatric trials
  • Experience in Phase 2, Phase 3, and Pediatric studies considered a valuable experience
  • Contribute to and help in strategic clinical investigational plans with substantial medical input
  • Collaborate with medical editors, sub-team members, and protocol execution team in preparation of protocols, pharmacy manuals, SAPs, MMP
  • Participate in investigator meetings, CRO meetings, and other meetings
  • Contribute to clinical study reports, protocols, CRF design, UATs, DMP, CCGs, Investigator Brochure, study data listings review, etc.
  • Interface with clinical operations, data management, biostatistics, and other functional teams in driving the execution of global clinical trials
  • Serve as the primary medical point of contact/medical monitor in responding to protocol-related inquiries, eligibility questions, safety issues, and other inquiries from investigative sites, CROs, CRAs, CRMs, and other matrix study team members
  • Perform ongoing medical review of clinical trial safety data – adverse events, serious adverse event, vitals, labs, protocol deviations, listings, and efficacy data – and respond as needed or in real-time as medical monitor and liaison
  • Collaborate with other members of the clinical team in the development and implementation of eCRFs, edit checks, coding, report development, and database lock processes
  • Perform interpretation and analysis of clinical trial data
  • Review patient narratives, clinical summaries, and Safety Update Reports
  • Collaborate with internal regulatory department in maintaining compliance in responding to health authority questions
  • Contribute to PSUR, DSUR, and other safety documents
  • Develop and contribute to SOPs and guidelines
  • Prepare manuscripts, posters, abstracts, and other scientific presentations

Education, Experience & Skills Requirements

  • Medicine (MD) or Physician-Scientist (MD-PhD, MD-MA)    
  • Physician, Industry or Academic Clinical Researcher
  • Basic research for > 3 years a plus (+)
  • Internal Medicine, Pediatrics, Genetics, or Endocrinology training and/or fellowship valuable
  • Experience in II, III &/or IV clinical trials with small or large molecules
  • Familiarity with FDA and EMA regulations, ICH, GCP, and GCDMP guidelines and standards for the conduct of sponsored clinical research with human subjects
  • Good presentation skills
  • Self-starter, ability to work independently and within a team with excellent communication, interpersonal and problem-solving skills.  Ability to be flexible and willing to bring innovation to rare disease clinical research

What We Offer

  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
careers

Medical Director

Apply Now