Associate Director/Director, Clinical Science

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Navire Pharma, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire’s team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

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://navirepharma.com / https://bridgebio.com

Location

San Francisco, CA

Who You Are

The Director of Clinical Science will play a supportive role in the clinical development of BBP-398 for oncology indications. Working in collaboration with Clinical Development, the position is responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start-up/ execution/ closeout, data analysis/reporting, and support of NDA/MAA filings.

Responsibilities

  • Acquire and utilize knowledge of clinical trial design to develop specific study concept sheets and protocols
  • Participate in protocol review discussions concerning scientific and procedural aspects of study design
  • In collaboration with Medical Writing and Clinical Operations, prepare study protocols, amendments, specific sections of study manuals and Investigator Meeting materials, and other documents as needed with limited guidance and supervision
  • In collaboration with Data Management, contribute to the design and development of CRFs, Data Management Manuals, and Data Analysis Plans
  • With MD supervision, address questions regarding scientific and related procedural issues from Investigators
  • Contribute to the design, preparation, and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations
  • Assist in the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures, and NDAs/MAAs
  • Support priorities within the functional area
  • Anticipate complex obstacles within a clinical study, and with guidance, implements solutions
  • May be asked to coordinate teams and provide direction
  • May lead two or more specific components of departmental strategic initiatives
  • Must be able to enter a new therapeutic area and summarize scientific information available in the published literature to integrate into new study development
  • Excellent verbal and written communication skills and interpersonal skills are required to maintain a working relationship with team members to ensure clinical studies’ scientific integrity
  • May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems

Education, Experience & Skills Requirements

  • Typically requires a higher degree such PharmD or Ph.D. in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization, or academic institution
  • 4 – 8+ years of relevant scientific and/or drug development experience with a BS degree in Biological Sciences, health care, or a related field
  • 4 – 6+ years of relevant scientific and/or drug development experience with an MS
  • Demonstrated ability to be a fast learner
  • Demonstrated ability to be flexible and adaptable to change, move between projects quickly, and provide support/expertise where needed.
  • Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as Spotfire
  • Knowledge of FDA, EMA, and ICH regulations and guidelines a must
  • Ability to effectively collaborate cross-functionally, across all levels of the organization

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

Associate Director/Director, Clinical Science

Apply Now