Headlands Research will never ask a candidate for personal identifiable information (date of birth, social security number, driver’s license information, etc) via email or messenger tools, or for a financial deposit of any kind. Reporting to the Director of Administration and Finance, the Assistant Director provides essential support to faculty and plays a key role in ensuring efficient and compliant research administration; leads talent management succession planning efforts while overseeing all sponsored research-related research administration functions; develops and implements financial models and strategies to enhance the efficiency of research and financial operations; serves as a trusted advisor to faculty and departmental leadership on financial and administrative aspects of sponsored research; creates and delivers clear, effective trainings and presentations; supervises and mentors research administration staff, and performs high-level financial work, including budget oversight, planning, and management; and acts as the primary liaison to MIT's central finance offices on research administration matters. ASSISTANT DIRECTOR OF RESEARCH ADMINISTRATION, Chemical Engineering, leads and oversees complex pre- and post-award financial operations and manages a team of 8-10 staff responsible for the department's full research administration portfolio at MIT.
Marlborough, MA30+ days ago
Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc. Contributes to company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally.
p>Highly detail-oriented with exceptional organizational skills Strong critical thinker who can prioritize, problem-solve, and execute under pressure Comfortable managing multiple priorities without losing sight of the big picture Tech-savvy with strong computer and reporting skills Clear, confident communicator with the ability to build trust across teams and external partners Customer- and patient-focused mindset. You will have the autonomy, visibility, and support to implement best-in-class operational processes, mentor and inspire your team, and directly impact enrollment performance, data quality, and financial outcomes.
p>The Senior Director & Global Head of Health Economics & Outcomes Research (HEOR)/ Payer Evidence Generation is a global strategic leader responsible for defining and communicating the clinical, economic, and humanistic value of the Omnipod portfolio and Insulet's future innovations, in partnership with members of the regional and local access community @ Insulet, Medical Affairs, Clinical Development, commercial strategy, R&D, Digital Health, Commercial, and Government Affairs. Oversee the design and execution of high-quality real-world evidence programs, epidemiological studies, burden-of-disease research, indirect comparisons, and PRO strategy to further demonstrate the unmet need in current diabetes care and the comparative clinical, economic and humanistic value of Insulet's current and future assets in addressing that need across our key markets.
p>POSITION SUMMARY: The Program Director is responsible for planning and managing the overall execution of the domestic and international research program including financial and grants management, strategic planning, ensuring study teams meet quality, budget and timeline targets, implementing operational strategies and/or decisions (with input from PI) in support of achieving research objectives, researching funding opportunities and leading grant development process, and supporting the development of organization infrastructure for team management, supervision, and leadership development, as well as other administrative and financial management activities to accomplish project goals and deliverables.
Provide program-level direction to study coordinators on the development of protocols, SOP/MOPs, data collection procedures, clinical and data quality management plans, data collection instruments, and training materials.
p>In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: - A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. This person will ensure efficient reviews, support business negotiations and contractual execution for selected projects, and lead strategic discussions with senior management, R&D, Commercial, Regulatory, Medical, and other stakeholders to define priorities for licensure, collaboration, M&A, or out-licensing.
li>People and Talent Management: Lead and motivate a high performing team of professionals; provide people management leadership by hiring the best talent, setting goals, developing associates, managing employee performance and compensation decisions, promoting teamwork and handling performance management of the team.
Cross Functional Partnership: Adept at establishing credibility with, as well as motivating and mentoring, designers, product managers, engineers, and business leaders with experience in engaging thoughtfully with the senior executive committee and working day to day with senior leaders.
Board Certification (or equivalent) or specialist training is highly desirable; drug development experience in neurology (Huntington's Disease) would be a great advantage, but not essential 10+ years industry experience or equivalent clinical academic experience Sound scientific and clinical judgment Successful track record of leading Phase 2/3 clinical programs (preferably in Huntington's drug development), including major interactions with Health Authorities Familiarity with concepts of clinical research and clinical trial design, including biostatistics, regulatory agency organization, guidelines, and practices Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues Outstanding leadership and collaboration skills working within a matrix environment. Collaborate closely with Preclinical, Regulatory Affairs, Medical Affairs and Commercial to ensure tight strategic integration of product development plans Be accountable via Clinical Research and Operations for all relevant timelines and deliverables Drive/supervise all major written deliverables (regulatory submissions, original articles, abstracts), and presentation materials Be responsible (as appropriate in line with SOPs) for final review and sign off with respect to all controlled documents including protocols, IBs, informed consent forms Influence internal and external audiences in a high impact, highly visible fashion Qualifications MD with strong research background or MD PhD, with a track record of successful research support and peer review publications.