Senior Clinical Trial Manager

Location
San Francisco, California
Posted
Jun 08, 2021
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Contract
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:

The (Senior) Clinical Trial Manager ensures the continuous and harmonized delivery of clinical studies to advance the development of acoramidis (formerly AG10). Operating as a leader within the organization, this role manages and implements critical operational activities for assigned clinical programs while ensuring GCP compliance, high study quality, and timely study completion.  

The (Senior) Clinical Trial Manager will leverage the mastery of clinical study management to ensure the efficient delivery of global clinical studies and the implementation of the clinical development plan, working independently and collaboratively to support the efficient delivery of global clinical studies andmeet the functional, organizational, and corporate goals of Eidos.

Responsibilities:
  • Support the Clinical Study Team for assigned projects
  • Manage overall study timelines and oversight of vendor deliverables  
  • Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates and Clinical Trial Assistants
  • Prepare / Review / Approve study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
  • Coordinate and contribute to the design of study materials such as CRFs, ICFs, patient diaries, study participation cards, and other study-related materials  
  • Assist with protocol development and study report completion
  • Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
  • Provide guidance, direction, and management to CRAs
  • Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in the coordination of data management activities
  • Coordinate study supplies
  • Assist with negotiating and manage contracts
  • Plan and participate in investigator meetings
  • Assist and support data query process
  • Ensure the trial master file is current and maintained


Education, Experience & Skills Requirements:
  • Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree is preferred
  • At least five years of biopharma industry experience required(relevant clinical trials experience, biotechnology, pharmaceutical, CRO, medical device industry) with at least 2-3 years of managing clinical trials
  • Must have vendor management experience in clinical operations/development
  • Orphan drug and/or rare disease knowledge is preferred
  • Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees understand their role in achieving success
  • Ability to build and maintain strong working relationships within the department and cross-functionally to meet a project or corporate goal
  • Must be able and willing to travel periodically
  • Experience with Microsoft Office Suite required (Word, Excel, MS Project or SmartSheets, Outlook)


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.