The Executive Director, Head Clinical Research Scientist role is an exciting opportunity for a highly motivated individual to be a key contributor to the development and execution of the clinical strategy across the oncology portfolio. The Head of CRS will lead the Clinical Development Team, to support early and late stage clinical development to have a strategic and scientific impact on current and future clinical programs, building and leading a team of clinical research scientist with expertise to collaboratively design, plan, implement, analyze, and report clinical studies.
This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.
- Support corporate goals by working closely with Senior Management
- Provide strategic support for clinical drug development programs by close interactions in a cross-functional environment by offering scientific and clinical guidance and expertise
- Lead a team of Clinical Research Scientists with diverse backgrounds and experience
- Provide scientific resourcing and expertise to support project teams and clinical trials
- Provide support for advisory boards, consultant meetings, and investigator meetings including preparation and/or delivery of presentations
- Understand the competitive landscape and provide insights on strategic development pathways
- Keeps abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory requirements
- Proactively seek out and recommend and as needed, develop process improvements
- Provides development, coaching and mentorship to direct reports
- Lead and/or contribute to the design of clinical studies
- As necessary, perform medical review of data for safety and efficacy evaluation
- Collaborate with the Project Team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
- Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
- In collaboration with the Project Team, contribute to database lock, statistical analysis plans, and preparation of Clinical Study Reports and other clinical documents.
- Represents the company at key national and international medical and scientific meetings
- Complete and/or lead other special projects
- Review and summarize relevant literature
- Contribute to drafting manuscripts and other publications and presentations
- Other duties as assigned
- Minimum of 7 years clinical development experience in the pharmaceutical/biotech industry (clinical science, medical writing, etc.)
- BS/MS/PhD in a related life science discipline or PharmD
- Prior oncology drug development experience preferred
- Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
- Patient profile and data listing review experience
- Strong analytical, problem-solving, and scientific writing skills
- Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills
- High level of organizational and project management skills
- Demonstrated ability to work independently in a matrix environment and prioritize and manage multiple tasks simultaneously
- Demonstrated ability to influence through collaboration
- Flexibility to accommodate changes in priorities and project needs
- Prior experience performing Medical Review, and writing/updating core development documents (e.g. protocols, CSRs, IBs, and ICFs) are required.
- Excellent interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, to foster/nurture teamwork, and to facilitate or drive fulfillment of strategic goals.
- Willing to serve as a mentor/advisor or support person for junior colleagues, leads by example with work-ethic and respect for colleagues
- Willingness to be very “hands-on” in a fast-paced work environment, and ability to reprioritize as needed.
- Previous experience successfully leading clinical scientist with responsibility for studies in multiple regions.
- Previous management experience required.
Job Location: Cambridge, MA
Please send resumes to email@example.com