Associate Director, Clinical Science
A biopharmaceutical company committed to applying scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases.
Contract Associate Director, Clinical Science (CS), with relevant clinical and drug development experience to support Clinical Science deliverables for oncology (solid tumor) clinical trials.
Position: Associate Director, Clinical Science (Oncology)
Location: Cambridge, MA
Duration: 12 months with extendable opportunities.
* Assist Medical Director as a clinical scientist on one or more solid tumor clinical studies
* Primary point of contact for medical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate
* In conjunction with Medical Director, support the creation of and/or review of clinical slides for internal and external meetings (i.e. Investigator Meetings, Advisory Boards, Steering Committee Meetings, etc.)
* 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.
* Draft the study clinical narratives as needed for health authority submissions and for final Clinical Study Report
* Provide additional support with site training as needed by CRO/site monitors (i.e. study coordinator and monitor meetings)
* In conjunction with Safety, review SAE narratives generated and provide feedback, as needed
* Build strong relationships with sites and data management vendor and attend site visits (SIVs, booster visits) as appropriate
* Bachelor's degree in a scientific or health-related field required
* Advanced Clinical/Science degree preferred (e.g. PharmD, PhD, RN, NP, MSN, MPH, MD with no post medical school experience, etc.)
* Minimum of 5+ years of clinical scientist experience in the pharmaceutical industry
* 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 and Spotfire and/or Rave
* 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 10%
Sthree US is acting as an Employment Business in relation to this vacancy.