Principal, TM Planning & Execution Lead - Clinical Mechanisms
Senior scientific operations leader responsible for planning and driving execution of in silico, in vivo and clinical sub-study workflows - across a diverse matrix of internal and external scientific partners - to rapidly generate and test hypotheses necessary to support early decision-making for expanded mainstream clinical activity in our Oncology portfolio, by:
- Integral partnering with Clinical Mechanism team(s) in developing project plans and driving execution to inform clinical progress, major activities include: protocol design, rapid data acquisition, specimen collection, selection, routing, testing, and ingestion/analysis/reporting of analytical results.
- Managing issues and risk mitigations for the portfolio of assets managed by the CM Leader, primary scope includes:
- Internal scientific partnerships driving biomarker sub-studies, translational R&D efforts and bioinformatics approaches to scientific evaluation of critical hypotheses,
- External collaborations for data acquisition, analysis and study activities,
- Publications and presentations (internal and external), and
- Regulatory responses and interactions.
- Establishing meeting agendas to drive CM portfolio delivery and documenting outcomes, decisions and key learnings to enhance collaboration and communication.
- Overseeing the consistency, integrity, completeness, and internal dissemination of biomarker data generation following review of results.
- Supporting efforts to curate and integrate datasets (biomarker results, sample characteristics, clinical outcome) to facilitate analysis, e.g. via Spotfire or other data visualization capabilities.
- Driving biomarker analysis and activities, including but not limited to, facilitating data transfer specification creation in collaboration technical leads and coordination with both internal and external partners to support biomarker sample movement.
- Creating visibility and maintaining transparency into collaborative activity that contributes to the clinical mechanism plan for the key questions.
- Coordinating the evaluation of proposals and ensuring delivery to appropriate collaboration team within expected timelines.
- Elaborating and ensuring effective execution of a robust process for regular program and portfolio strategy reviews facilitated by Clinical Mechanisms staff.
- Provides scientific leadership in one or more critical areas and "chief of staff" support for Clinical Mechanisms leader to enhance operational connectivity and forge a development path into other scientific disciplines bringing enriched operational expertise.
- Serving as TMES liaison to lead or support other strategic and process improvement initiatives affecting his/her portfolio area(s) as required.
- Leads a team of Principal, Planning & Execution Leads in support of early asset development and translational research to provide a cohesive alignment across the early TM scientific environment.
- B.S., M.S., PhD in a scientific discipline; PMP or equivalent experience is desirable.
- 10+ years pharmaceutical industry experience in a variety of operational/scientific roles minimum; 5+ years' experience as a matrix leader in a highly diversified environment; 5+ years' experience in direct line management of senior scientific/operational staff.
- Thorough understanding of clinical data management and specimen acquisition and logistics practices with experience designing end-to-end workflows for optimized, repeatable execution.
- Shapes strategic approaches to scientific delivery, utilizing sophisticated negotiation and scenario planning with resources both internal and external.
- Works with a sense of urgency and experience managing multiple projects, building structure from ambiguity and helping teams to develop priorities.
- Experience designing and leading complex, global projects comprised of virtual team members of diverse styles, driving to successful outcomes with and without direct management responsibilities.
- Drives effective contract/fiscal management of project activities; experienced with the development of business cases for options based decision-making and effective vendor management for externally contracted work.
- Skilled listener with ability to manage complex internal - up, across, and down the hierarchy - and external relationships through constructive conflict management; experience with third party governance oversight desirable.
- Negotiates an enterprise (vs. functional) perspective across BMS.
- Experienced in developing and implementing agile, creative solutions, utilizing direct and indirect resources, to solve business challenges within the line organization, across the company, and in partnership with external collaborators.
- Strong communicator experienced with influencing and interacting at all levels including with senior scientific, operational or external thought leaders to drive connectivity and efficiency of collaborative research.
- Position will be located in Cambridge, MA.