Associate Director, CSS Early Development at Agios Pharmaceuticals
Posted in Other 6 days ago.
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Location: Cambridge, MassachusettsJob Description:
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Agios Pharmaceuticals HQ
# of openings
Associate Director, Clinical Science
Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has one approved oncology precision medicine and multiple first-in-class investigational therapies in clinical and/or preclinical development.
Agios is seeking an Associate Director, Clinical Science (CS), with relevant clinical and drug development experience to join the Clinical Development group and support Clinical Science deliverables for clinical trials and programs associated with the clinical development of molecules in the stages of clinical development (Phase I - III). The optimal candidate will have the desire to proactively participate within a cross functional team of internal clinical and commercial colleagues and have the ability to interact with external experts and investigators.
- Assist Medical Director and/or interface internally and externally as the primary clinical science lead of a given study or program
- Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate
- Primary liaison for internal Clinical Operations for site selection, site start-up activities, etc.
- In conjunction with Medical Director, support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, SIVs, Advisory Boards, Steering Committee Meetings, etc.)
- Assist in the collection and compilation of data and coordinate review/submission to scientific meetings for abstracts/posters and other publicly distributed materials
- Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, etc. Conduct literature searches, draft background sections, and ensure that standardized disease/molecule specific language in incorporated (i.e. eligibility and dose modification criteria)
- Perform clinical review of data listings and essential study data within generated statistical reports (eg, SAS outputs) and other available data surveillance tools (eg, Spotfire, Rave) and partner with Data Management in generating relevant queries.
- Attend Safety Review Meetings and track or analyze any potential safety event within a given study and across studies in conjunction with Safety
- Draft the study clinical narratives as needed for health authority submissions and for final Clinical Study Report
- Review and develop Investigator Meeting agendas with Operations. Provide additional support with site training as needed by CRO/site monitors (i.e. study coordinator and monitor meetings)
- Participate in CRF design and review for CRF design and instructions for unique CRFs as well as data quality plan and study data review plan
- In conjunction with Safety, review SAE narratives generated and provide feedback, as needed.
- Establish and/or coordinate use of consistent ICF risk language based upon IB/IND updates as required, protocol eligibility criteria, protocol dose modification criteria, protocol safety language, CRFs, and CRF instructions across studies
- Build strong relationships with sites and KOLs and attend site visits (SIVs, booster visits) as appropriate
Minimum Requirements and Preferred Qualifications
- Bachelor's degree in a scientific or health-related field required
- Advanced Clinical/Science degree preferred (e.g. PharmD, PhD, MSN, MPH, MD with no post medical school experience, etc.)
- Minimum of 6+ years of clinical research experience and/or pharmaceutical industry experience (a focus on drug development is preferred)
- Experience working on cross-functional teams
- Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance
- Understanding of product and safety profiles
- Familiar with GCP, ICH and other relevant guidelines
- Ability to interact and effectively communicate with all levels of personnel within the organization and with clients of the Sponsor company (i.e., investigators, vendors and CROs)
- Ability to serve on multiple interdepartmental teams
- Strong working knowledge of applications in Microsoft Office suite, including Excel and PowerPoint
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
- Demonstrated strong organizational and interpersonal skills, building internal and external relationships, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail
- Ability to travel up to 20%
- Drives Clarity - Sets the direction and manages the delivery of results (directly or indirectly), choices on priorities and removes barriers
- Collaborates - Work in and with teams to achieve outcomes that individuals would not have been able to achieve alone
- Executes and Operates to a High Standard - Acts with a sense of urgency; with the end result in mind and is able follow through to deliver exceptional results
- Listens to Understand - Listens to learn and understand; appreciates and responds to the needs and motivations of others
- Builds Networks - Builds networks internally and externally to stay relevant on new discoveries, trends and uses them to make meaningful connections to drive innovation and learning
- Makes Sound Timely Decisions - Integrates knowledge to analyze information and solve problems; uses judgment to make timely decisions
- Know and Show your Stuff - Possesses technical or professional expertise and is able to apply it at Agios to create value / impact