Director or Senior Director, Clinical Data Management

Boston, MA

Imbria Pharmaceuticals’ mission is to translate our understanding of cellular metabolism into innovative medicines that improve the lives of patients with limited or inadequate treatment options. The company was founded by doctors and launched by an all doctor executive team motivated by the promise of bringing new therapies to people in need.

We are propelled by a deep scientific interest in cellular metabolism and the mitochondria, and are guided by both values and a code of business conduct built upon our commitment to always put the patients, families and communities we serve at the forefront of all that we do. More information can be found at www.imbria.com.

 

The Director or Senior Director, Clinical Data Management leads clinical development programs for the CDM function including the direct management of clinical data managers and programmers within the Data Science & Analytics Department and technical oversight of external clinical data resources assigned a role on Imbria Pharma clinical trials.  In addition, the Director provides cross-functional leadership of R&D initiatives and Data Science & Analytics responsibilities including our EDC strategy, maintenance of data standards, and process improvements to address changing regulatory demands (e.g., ICH Guideline E6|R2).  The CDM function works collaboratively with adjacent R&D functions in the design and implementation of eCRFs, EDC builds, ePRO diaries, risk-based monitoring plans, maintenance of eSource documents and data, etc.  Externally, the CDM function provides sponsor oversight for CRO-resourced clinical trials including scoping the trials, project management, relationship management, approval of deliverables, and coordination of internal reviews.  Lastly, there are diverse opportunities to lend data expertise to projects arising across clinical development to include among others, eTMF, cloud storage and transit, and data visualization as well as other projects where technology and process improvements can add efficiency and protect data integrity.

Responsibilities

  • Contribute data expertise to the clinical development strategy and development plan on emerging drug products;
  • Establish a Data Standards Committee and lead the clinical development functions through a conversation on standardized data collection and the importance of documented change control;
  • Author, review, and approve CDM SOPs that reflect industry standards and emerging best practices especially in the complex interactions among external providers contributing data to clinical trials (e.g., clinical laboratories, ePRO providers, mobile devices, etc.).
  • Participate in industry forums/consortia, user groups, and professional organizations (e.g., SCDM) to maintain an informed view on single source EHR initiatives, RWE, and other current topics;
  • Act as data liaison to FDA/regulatory agencies, CROs, external partners, and third-party data vendors;
  • Provide operational leadership for individual clinical trials and development programs ensuring effective cross-functional teams and timely program deliverables;
  • Develop departmental work tools to communicate Imbria Pharma preferences and standards, train external and internal staff, and ensure nuanced compliance with regulatory requirements.

Minimum Requirements

  • BA or BS degree, preferably in a health-related field;
  • Ten years of experience in delivery of clinical trials;
  • Experience with Phase 1-3 and RWE clinical trials in multiple therapeutic areas;
  • Experience in a regulatory environment within biopharmaceutical product development;
  • Ability to provide leadership for multiple and demanding projects, managing internal resources as well as outsourced trials and programs;
  • Knowledge of data methods and standards as commonly applied in clinical trials including EDC systems, CDASH, and 21 CFR Part 11;
  • Strong communication and presentation skills, both verbal and written, with the ability to inform and influence;
  • Proficiency in representative data tools;
  • Good organizational and problem-solving skills;
  • Occasional travel.

Imbria offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to hr@imbria.com.