Associate Director, Clinical Science

Full Time On-Site/Hybrid Clinical Development Director Clinical Science Apply for this Job Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Associate Director, Clinical Science to join our growing Clinical Development team. We want someone who cares about this important work, and who is driven to connect to our mission of helping these patient communities. The Associate Director, Clinical Science will 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 interact with external experts and investigators.

What you will do:

• Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate; Assist Medical Director and/or interface internally and externally as the primary clinical science lead of a given study or program.
• 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 (e.g., SAS outputs) and other available data surveillance tools (e.g., 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.

What you bring:

• 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) or another related field.
• 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 as needed.