New

Associate Director, Clinical Trial Transparency and Disclosure Specialist

Kura Oncology
401(k), stock options
United States, Massachusetts, Boston
2 Seaport Lane (Show on map)
Jan 07, 2025
Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. ESSENTIAL JOB FUNCTIONS: The Clinical Trials Transparency (CTT) and Disclosure Specialist is responsible for leading and managing global clinical trial disclosure and data transparency activities per applicable laws, regulations, and policies. This role will serve as a subject matter expert and primary point of contact for transparency and disclosure activities (e.g., clinical trial results postings, document redactions, and layperson synopses and results summaries). The role will partner with and lead interactions with senior management and team members in relevant functional areas and manage staff and/or vendors who are directly involved in activities related to disclosure, transparency, layperson synopses and summaries and clinical study diversity planning. Execute CTT book of work and provide vendor oversight; Lead the development of overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessary Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documents Ensure lean writing practices for regulatory documents such as Clinical Trial Protocols, Investigator's Brochures, Informed Consent templates and Clinical Study Reports to minimize CCI and PPD Analyze, validate, and prioritize complex and dynamic information from a diverse range of sources in response to technical and operational challenges Manage, track and present assigned book-of-work, compile and report performance metrics Manage the preparation of plain language (layperson) synopses and summaries and redaction of clinical documents in accordance with FDA requirements, EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulations Educate and provide company-wide awareness of transparency/disclosure regulations and industry trends, as well as requirements for layperson summaries and clinical study diversity planning. Coordinate efforts of cross-functional teams to produce documents & postings (e.g., plain language (layperson) summaries, interim and/or results postings, and redaction documents), acting as liaison between the vendor and internal teams For relevant trials, collaborate with internal and external stakeholders to develop and implement diversity action plans in accordance with FDA guidance Work on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plans Accountable for partnering with CRO and other vendors Provide input to, support and/or be a participant in change initiatives Act as a subject matter expert during audits and regulatory inspections Take on additional responsibilities as assigned by manager JOB SPECIFICATIONS: Minimum of 7 years' experience working in the biotech or pharma industry within Clinical Development, Clinical Trial Management or Medical Writing; including a minimum of 4 years in transparency and disclosure. Experience writing plain language (layperson) summaries, results postings, and redactions and understanding of Good Lay Summary Practice (CTEG working Group) Expertise with postings on clinicaltrials.gov and with EU CTR 536/2014 regulations Deep understanding of US and EU requirements for global transparency and clinical trial disclosure, as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.) Experience working with CTIS preferred Understands the clinical drug development process, including clinical trial design, operations and results analysis Strong leadership, planning, and project management skills, along with initiative and ability to be productive independently and with minimal administrative support Ability to evaluate and recommend process improvement and suggest/implement best practices Ability to maintain familiarity with current industry practices, regulatory requirements and guidelines that effect CTT, layperson summaries and clinical study diversity planning Outstanding oral and written communication skills Strong analytical and problem-solving skills; ability to organize/track complex information & prioritize Familiarity and comfortability working with and discussing scientific data Project and stakeholder management experience Flexible; adapts work style to meet organization needs Proficient with Microsoft Office products such as (Outlook, Word, Excel, PowerPoint, SharePoint, and Teams), Veeva Vault, and Adobe Suite Experience contributing to outsourcing strategies and vendor selection, including resourcing/budgeting forecasts for assigned projects The base range is $169,150 - $192,244 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus. Kura's Values that are used for candidate selection and performance assessments: We work as one for patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves The Kura Package 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! Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of blood cancers and solid tumors. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts. Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). For additional information, please visit Kura's website atwww.kuraoncology.comand follow us onXandLinkedIn. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.