Associate Director – Clinical Scientist

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🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $180k - $264k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Kura Oncology, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🏥 Healthcare

🍽️ Food & Beverage

💼 Consulting

💰 $125M Post-IPO Debt on 2022-11

Healthcare • Food & Beverage • Consulting

Kura Oncology, Inc. is a biopharmaceutical company specializing in the discovery and development of precision medicines designed to target cancer cells selectively. The company focuses on creating novel therapies aimed at improving patient outcomes in areas with significant unmet medical needs, such as head and neck cancer, lung cancer, and acute leukemias. Kura Oncology conducts clinical trials for its pipeline products, including Ziftomenib and Tipifarnib, to find effective treatments for conditions like Acute Myeloid Leukemia and Head and Neck Squamous Cell Carcinoma. The company is committed to the promise of precision oncology, striving to improve the quality and longevity of life for cancer patients by combining innovative therapies with existing standards of care.

📋 Description

• Lead the clinical study protocol development process and translate strategy into executable clinical protocols and related documents • Collaborate with biostatistics, clinical pharmacology, translational medicine, clinical operations and data management experts on trial execution plans • Contribute to CRF design, data review plans, statistical analysis plan review and finalization • Review, analyze and interpret study results and ensure accurate data reporting • Monitor emerging clinical safety, efficacy and PK/PD data; identify issues and develop strategic solutions • Conduct literature reviews to support study-data interpretation and next steps • Work closely with the medical monitor on pertinent study information, including safety and efficacy data • Support clinical sections of regulatory documents, including INDs, clinical study reports, investigator brochures, annual reports and regulatory submissions • Support target/pathway engagement assays, dose and schedule selection, and stratification biomarkers • Develop presentations and communicate study results internally and to external audiences, including investigators and scientific conferences • Maintain current knowledge of external scientific innovations and incorporate relevant developments into clinical trial strategy • Serve as clinical science representative on assigned cross-functional teams

🎯 Requirements

• Advanced clinical or science degree, such as RN, MA, PharmD, NP or PhD • Minimum of MA + 5 years of clinical experience or PharmD/PhD + 3 years • Technical/operational experience planning, executing, reporting and publishing pharmaceutical-industry clinical studies • Demonstrated ability to review, summarize, prepare and present study data • Fluency in English, written and verbal • Thorough understanding of drug development from pre-IND through registration and post-registration • Broad understanding of preclinical, regulatory, pharmacovigilance, drug supply, data sciences and clinical operations • Ability to interpret and communicate clinical information, literature reviews, competitive intelligence and changing treatment paradigms • Understanding of trial design and statistics for clinical protocol design • Track record interpreting, analyzing and presenting clinical data, including aggregate data analyses • Hands-on experience with systematic literature searches, summarizing results and presenting conclusions • Ability to work effectively in collaborative, cross-functional environments • Strong organization, documentation and communication skills with ability to multitask • Excellent interpersonal and cross-disciplinary collaboration skills • Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations • Ability to travel up to approximately 30% of the time

🏖️ Benefits

• Kura's compensation package includes generous benefits • Equity • Participation in an annual target bonus • Career advancement/ development opportunities • Competitive comp package • Bonus • 401K + Employer contributions • Generous stock options • ESPP Plan • 20 days of PTO to start • 18 Holidays (Including Summer & Winter Break) • Generous Benefits Package with a variety of plans available with a substantial employer match • Paid Paternity/Maternity Leave • In-Office Catered lunches • Home Office Setup • Lifestyle Spending Stipend • Commuter Stipend (Boston Office) • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!