Associate Director – Clinical Scientist

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the development of clinical study protocols and convert strategic plans into actionable clinical protocols and associated documents.

• Collaborate with experts in biostatistics, clinical pharmacology, translational medicine, clinical operations, and data management to formulate trial execution plans.

• Contribute to the design of Case Report Forms (CRFs), data review plans, and assist in the review and finalization of statistical analysis plans.

• Analyze and interpret study results to ensure precise data reporting.

• Monitor emerging clinical safety, efficacy, and pharmacokinetics/pharmacodynamics (PK/PD) data; identify challenges and devise strategic solutions.

• Conduct literature reviews to aid in the interpretation of study data and determine subsequent steps.

• Collaborate closely with the medical monitor regarding relevant study information, including safety and efficacy data.

• Assist in preparing clinical sections of regulatory documents, including INDs, clinical study reports, investigator brochures, annual reports, and other regulatory submissions.

• Support target/pathway engagement assays, dose and schedule selection, and identify stratification biomarkers.

• Create presentations and share study results with internal teams and external audiences, including investigators and at scientific conferences.

• Stay updated on external scientific advancements and integrate relevant developments into clinical trial strategies.

• Act as the clinical science representative on assigned cross-functional teams.

⛳️ Requirements

• An advanced degree in clinical or scientific fields, such as RN, MA, PharmD, NP, or PhD.

• A minimum of 5 years of clinical experience with an MA or 3 years with a PharmD/PhD.

• Experience in the pharmaceutical industry related to planning, executing, reporting, and publishing clinical studies.

• Proven ability to review, summarize, prepare, and present study data effectively.

• Proficiency in English, both written and spoken.

• In-depth knowledge of drug development processes from pre-IND through registration and post-registration stages.

• Comprehensive understanding of preclinical, regulatory, pharmacovigilance, drug supply, data sciences, and clinical operations.

• Capability to interpret and communicate clinical information, literature reviews, competitive intelligence, and evolving treatment paradigms.

• Familiarity with trial design and statistical principles for clinical protocol development.

• Demonstrated experience in interpreting, analyzing, and presenting clinical data, including aggregate analyses.

• Hands-on experience with systematic literature reviews, summarizing findings, and presenting conclusions.

• Ability to thrive in collaborative, cross-functional settings.

• Strong organizational, documentation, and communication skills with the ability to manage multiple tasks.

• Excellent interpersonal skills and capability for cross-disciplinary collaboration.

• Comprehensive knowledge of Good Clinical Practice (GCP), ICH Guidelines, and current US FDA regulations.

• Willingness to travel up to approximately 30% of the time.

🏝️ Benefits

• Kura offers a competitive compensation package that includes generous benefits.

• Equity opportunities.

• Eligibility for participation in an annual target bonus.

• Opportunities for career advancement and development.

• Competitive compensation package.

• Bonus structure.

• 401K plan with employer contributions.

• Generous stock options available.

• Employee Stock Purchase Plan (ESPP).

• Starting with 20 days of paid time off (PTO).

• 18 holidays, including breaks during the summer and winter.

• Comprehensive benefits package with a variety of plans and a substantial employer match.

• Paid maternity/paternity leave.

• Catered lunches in the office.

• Support for home office setup.

• Lifestyle spending stipend.

• Commuter stipend for the Boston office.

• Regular social activities for employees, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and more!