Senior/Executive Director, Clinical Development

Location
San Francisco, California
Posted
Jul 29, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our product candidate, AG10, is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

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  eidostx.com/ www.bridgebio.com

Who You Are:

This individual will be responsible for developing and executing the clinical development program for Eidos, including the clinical leadership of the trials, input in regulatory interactions, and providing medical monitoring and scientific support into study execution. The individual will lead and provide strategic direction to the cross-functional clinical teams.

Responsibilities:
  • Contribute to design scientifically rigorous, operationally feasible, and cost-effective clinical protocols that reflect clinical development strategy
  • Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, INDs, Safety, and Annual reports, handling of responses to regulatory agencies and Ethics Committees regarding questions about clinical development issues (e.g., safety or efficacy) as well as respond to protocol related questions
  • Contribute to clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development
  • Serve as the Medical Monitor, responsible for oversight of and collaboration with the CRO Medical Monitors, review of clinical study data, and as serve as a medical expert for Phase III studies, supporting the process from protocol development (protocol amendment) through study execution to completion of study reports and integrated regulatory documentations
  • Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Statistics & Programming team
  • In collaboration with Clinical Operations and data management, monitor study quality metrics; Participate in study team meetings and meeting with the vendors/partners; Provide support to Clinical Operations in relevant aspects of study execution, Facilitate productive cross-functional collaboration for study management
  • Present study updates, interim results, and final topline data to senior management as required
  • Implement clinical R&D policies, SOPs, and related directives
  • Capable of prioritizing tasks and delivering on deadlines with high-performance standards and attention to detail
  • Demonstrated leadership skills and ability to collaborate successfully with multiple functions and external vendors in a cross-functional team environment


Education, Experience & Skills Requirements:
  • 5+ years of clinical development experience 
  • Experience in clinical research and/or drug development in CRO or pharmaceutical environment.
  • MD degree, specialty, or subspecialty training is preferred


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


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