Director, Clinical Research Scientist

Sumitomo Pharma • Marlborough, MA

21h

About The Position

The Director, 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. This individual will manage a Clinical Development Clinical Research Scientist team to support early and late-stage clinical development to have a strategic and scientific impact on current and future clinical programs. This highly visible key role offers outstanding career and personal development opportunities for motivated candidates.

Requirements

• BS/MS/PhD in a related life science discipline or PharmD; RN, BSN or MSN preferred.
• Minimum of 10 years of clinical development experience in the pharmaceutical/biotech industry (clinical science, medical writing, etc.)
• Prior oncology drug development experience required.
• Prior experience leading a Clinical Research Scientist team through study design and startup, as well as NDA submission and approval process.
• The candidate will have clinical experience in an oncology clinic, and leading a team through NDA, establish data visualization tools, deliver high touch support of sites in multiple regions.
• Experience in the 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.
• Must possess strong analytical, problem-solving, and scientific writing skills.
• Excellent oral and written communication skills and solid PowerPoint, Word, and Excel.
• High level of organizational and project management skills.
• Demonstrated ability to work independently in a matrix environment with the ability to 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.
• Willing to serve as a mentor/advisor or support person for junior colleagues; leads by example with a strong work ethic and respect for colleagues.
• Willingness to be very “hands-on” in a fast-paced work environment and ability to reprioritize as needed.

Nice To Haves

• RN, BSN or MSN preferred.

Responsibilities

• Train Clinical Research Scientists to execute clinical trials in collaboration with clinical operations and medical directors to support study start up, present at SIV, develop deep relationships with Principal Investigators, review eligibility forms, support trials with intensive monitoring support, data review, and data cleaning.
• Lead, recruit and train a team of Clinical Research Scientists with diverse backgrounds and experience to meet the needs of the evolving business.
• Train Clinical Research Scientists to support NDA submissions and all regulatory responses.
• Support corporate goals by working closely with Senior Management.
• Provide strategic support and direction for clinical drug development programs through close interactions in a cross-functional environment by offering scientific and clinical guidance and expertise.
• Provide support for advisory boards, consultant, and investigator meetings, including the preparation and/or delivery of presentations.
• Understand the competitive landscape and provide insights on strategic development pathways.
• Keep abreast of oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory requirements.
• Proactively seek out and recommend process improvements.
• Provide development, coaching, and mentorship to direct reports in support of building a high-performing team.
• 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.
• Contribute to drafting manuscripts and other publications and presentations.

Benefits

• Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.
• Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree