Deciphera Pharmaceuticals jobs - 35 jobs

The Director, Clinical Operations is responsible for ensuring that clinical stage programs achieve strategic and operational objectives within established timelines, budget, and quality standards. This role provides leadership to the Clinical Operations team, contributes to the development of clinical program strategies, and ensures superior execution, collaboration, and transparency across functions. The Director partners with internal stakeholders and external partners to drive high-quality clinical trial delivery in a fast-paced, small-to-midsize biotech environment. Key Responsibilities: Program Strategy & Leadership (35%) Develop and execute clinical program strategies that align with corporate goals. Provide leadership to the Clinical Operations team and ensure efficient resource allocation across programs. Clinical Trial Oversight (25%) Ensure clinical trials are properly defined, planned, and executed according to GCP, ICH, and FDA standards. Oversee study timelines, budgets, and quality metrics to achieve operational excellence. Regulatory & Documentation Support (15%) Assist in authoring key regulatory documents and ensure that clinical program deliverables align with submission requirements and regulatory expectations. Vendor & CRO Management (15%) Manage and oversee CROs, vendors, and external partners to ensure performance, deliverables, and financial accountability meet expectations. Team Development & Collaboration (10%) Foster a collaborative culture within Clinical Operations and serve as a leadership role model. Promote transparent communication, accountability, and operational discipline across the department. Other duties and responsibilities as assigned. Qualifications Required Qualifications: • Bachelor's or Master's degree in health science or related field required. • Minimum of 12 years of clinical research experience, with at least 10 years in clinical trial management and operational leadership roles. • Comprehensive understanding of clinical development processes, GCP, ICH, and global regulatory requirements. • Proven ability to lead cross-functional teams and manage external CROs and vendors effectively. • Exceptional leadership, communication, and organizational skills. • Strong strategic thinking and problem-solving abilities with a focus on operational excellence. • Proven success managing global clinical programs in a small-to-midsize biotechnology environment. • Strong Phase III clinical trial experience and demonstrated global experience. Preferred Capabilities: • Experience in oncology or rare disease clinical programs preferred. • Demonstrated success managing global programs in a small-to-midsize biotech environment. • Experience with clinical systems such as eTMF, CTMS, and EDC platforms. • Proficiency in budget management and vendor performance tracking. • Ability to lead in a dynamic, collaborative, and evolving organization. Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $190,000 - $261,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a Program Leader, Next Wave to serve as a Program Leader (PL) for our emerging portfolio of programs to address rare, neuromuscular diseases. This individual will act as the key point of contact for early-stage or "next wave" assets and drive these programs through critical developmental transition points. This utility player must possess an entrepreneurial spirit and an enterprise mindset, capable of bridging the gap between scientific discovery, clinical reality, and commercial landscape. You will lead cross-functional teams, define the integrated development strategy, and ensure the successful delivery of projects within scope, time, and budget. You will work in a fast-paced dynamic environment with a sense of urgency, acting as a primary driver of value creation for the company's future.This position reports to the Head of Program Leadership and Management. Position Responsibilities: Strategic Program Leadership Serve as the Program Leader (PL) for assigned pipeline assets, holding accountability for the development and execution of the Integrated Development Plan (IDP), consisting of overall project timeline to regulatory approval Drive assets through major inflection points (e.g., advancing program to development, IND enablement, Clinical Phase 1 to 2 transitions). Lead the cross-functional Program Team (PT), facilitating high-quality decision-making and ensuring alignment across cross-functional partners and integrating across Research & Development Lead the definition and maintenance of the Target Product Profile (TPP), in collaboration with cross-functional partners End-to-End Process & Risk Management Apply a strong understanding of end-to-end drug development, process management, and organizational interdependencies to anticipate challenges before they become critical path blockers and partner with the team to develop mitigation strategies Proactively identify, articulate, escalate, and manage program risks; collaborate with key stakeholders to recommend constructive solutions rather than just reporting on status. Communication & Enterprise Leadership Act as the central communication hub, ensuring effective and timely communication to team members and senior leadership regarding program status, key milestones, and strategic pivots. Foster a culture of collaboration and accountability, resolving conflicts within the team and ensuring all functions are moving in lockstep. Candidate Requirements: Advanced degree preferred (e.g., PhD, PharmD, or MBA); real-world experience in life sciences is required The ideal candidate will have prior experience working on pre-clinical or clinical stage programs in either neurology or neuromuscular diseases. The ideal candidate will have direct, hands-on experience on drug development in a clinical stage program across either clinical research, biostatistics, or regulatory affairs Proven track record of moving a clinical-stage molecule through a major inflection point or interface (e.g., Research to Development, Clinical Phase 1 to 2, or Clinical to Commercial) Skills & Capabilities: Utility Player: Demonstrated ability to flex between high-level strategy and hands-on execution with an entrepreneurial spirit. End-to-End Fluency: Strong understanding of the drug development lifecycle, from discovery target validation through to commercial launch. Leadership: Exceptional communication and interpersonal skills with the ability to lead without authority and influence stakeholders across the organization. Operational Excellence: Extremely well-organized with the ability to manage multiple programs and drive clarity in complex, ambiguous situations Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a motivated, energetic, and outstanding individual with experience in clinical pharmacology and pharmacometrics to join our team in developing novel biologic therapies that target protein growth factors in the disease microenvironment. The Director/Senior Director of Clinical Pharmacology, reporting to the Head of Clinical Pharmacology, will have strong quantitative clinical pharmacology skills and hands-on modeling and simulation experience. This individual will be responsible for the analysis and interpretation of PK, PD, and efficacy data to guide the development of biologics including monoclonal antibodies. The ideal candidate will have significant experience in subcutaneous drug development. Position Responsibilities: Lead clinical pharmacology strategies across multiple programs at various stages of clinical development Execute modeling and simulation plans including PK/PD, population PK, and exposure-response analyses to guide clinical trial design, dose selection and optimization Develop clinical pharmacology plans to bridge IV to SC dosing Provide pediatric clinical pharmacology expertise and co-lead workstreams related to formulation development and sub-cutaneous route of administration Apply model-based drug development principles to answer key development questions enabling efficient drug development Contribute to preparation of regulatory documents and participate in discussions with Regulatory Agencies, with a focus on Model-informed Drug Development (MIDD). Contribute to clinical protocol design, study execution, data analysis, and writing clinical study reports Collaborate and mentor bioanalytical and translational team to develop comprehensive preclinical and clinical PK/PD strategy Candidate Requirements: PhD in pharmacokinetics or pharmacology 7-10 years of experience in pharma/biotech industry, with proven track record of using clinical pharmacology to guide clinical trial/dosing decision Proficient knowledge and hands-on experience in all aspects of clinical pharmacology, including modeling and simulation of pharmacokinetic, pharmacodynamic, and efficacy relationships, including expertise with population modeling Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology assessing the clinical relevance Experience in subcutaneous drug development and IV to SC bridging is highly desired Strong interpersonal skills to work effectively in a team setting/matrix-type organization Understands the drug development process from pre-IND through BLA Highly organized, outcome-oriented, self-motivated performer Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: General: Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals. Collaborate with internal and external team members for the planning and execution of clinical trials. Accountable for coordination of planning, initiation, completion, and reporting of clinical study protocols within or across programs from team endorsement to reporting. Ensure clinical trials meet time, quality, and cost targets consistent with the overall Clinical Development Plan. Lead the development of and provide input into study-related documents, including ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc. Also performs review and provides strong operational input in the development of clinical trial protocols and CSRs Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs). Collaborate with Legal & Clinical Contracting & Outsourcing (and others, as needed) on the development and management of study specific agreements/budgets (i.e., non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.). Organize and manage project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly. Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the business financial standards. Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures. Monitor and visit clinical study sites as needed. Track, collect, and review clinical documentation for clinical trials. Complete other duties as assigned by the manager. Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Strategy Team (CST). Serves as the key CST point of contact for the trial. Accountable for the successful preparation and presentation of operational content at key leadership discussions (CST, GPT, SLT, etc.). Ensures strong oversight, review, and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines. Accountable for partnering with CRO in audit responses and addressing quality issues. Filters, prioritizes, analyzes, and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges. Ensures inspection readiness application for all assigned clinical trials. Sr. CTL: Manages projects/work streams with high complexity, risk, impact, and reach. Manages large-sized global clinical teams with members also from outside the direct working environment. Coordinates stakeholders from closely related areas and beyond. Demonstrates skills in successfully leading international teams in the matrix organization and directs, influences, and motivates people; creates and leads a positive working climate. Develop and lead operational and therapeutic area training for internal and external study team members. Directs multiple studies in parallel and/or be called upon for program management duties. Exhibits Subject Matter Expert level understanding of multiple functions and functional processes. Accountable for successful project execution including definition of milestones and clarification of project scope. Receives minimal guidance and works independently. Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical expert on cross functional teams or projects JOB SPECIFICATIONS: Advanced degree desirable; PM certification desirable Ideally 10 years clinical research experience with at least 5 years of direct trial management experience Some experience in oncology preferred. Experience in CRO oversight is required Manages large sized global clinical trial team Works with minimal or no supervision Ability to mentor junior staff Self-directed and proactive handles multiple complex tasks Strong organization, documentation, and communication skills. Excellent interpersonal skills: ability to collaborate across disciplines. Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations. Ability to travel up to approximately 30% of time. Hybrid on-site in Boston two days per week. The base range for a Senior CTL is $177,943 - $204,400 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. #LI-RM1 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 committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1 -mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are 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. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

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: Reporting to the Executive Director of R&D Quality Assurance, the Sr Manager/Associate Director, PV-GCP (Pharmacovigilance-Good Clinical Practice) is primarily responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for pre and post-marketing Pharmacovigilance activities and will provide QA GCP support to assigned clinical development programs.. The incumbent may also be responsible for supporting relevant processes and programs that ensure computer system assurance (CSA) for applicable clinical/PV systems. The incumbent builds collaborative, supportive relationships and serves as a point of contact for Quality Assurance for PV and other relevant departments including clinical development, trial operations, clinical data sciences, and other stakeholders. Supports and maintains a quality-focused culture and mindset across the organization. * Develop collaborative partnerships with PV and assigned clinical study teams/study team leaders to maintain a current understanding of potential areas of quality risk exposure within the context of ongoing clinical studies and across clinical programs as assigned. * Ensure compliance with pre and most marketing PV requirements, and GCP activities including facilitating and managing internal and external PV/GCP audits/audit programs, as applicable. * Implement and support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance * Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment). * Assist with the development and tracking of trending and metrics of internal as well as external vendor quality issues. * Provide related training on new regulatory requirements and industry practices. * Lead and manage PV inspection readiness activities and other key programs as applicable. * Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and front room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable. * Promote quality and risk management principles (e.g., quality by design, critical to quality focuses, risk assessment and risk ranking, establishment of risk thresholds and tolerance limits) when supporting innovative programs and advancing ongoing clinical programs. * Maintain accountability for ensuring risk-based strategies are utilized when managing and mitigating quality issues and supporting clinical studies, ensuring study-specific risk management activities and strategies are utilized consistently across programs. JOB SPECIFICATIONS: * BA/BS degree required, advanced degree a * For Senior Manager a minimum of 6 years, Associate Director a minimum of 8 years of experience in the bio-pharmaceutical R&D industry with at least 4 years (6 for AD) or more years in a PV/GCP Quality Assurance Pre and post marketing PV experience is required. * Minimum 2 years of experience leading teams, projects, programs or direct reports required. * Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs). * Demonstrated knowledge and application of Global regulations and guidance for GVP, and GCP, and an understanding of requirements for validated computerized systems used in clinical trials and PV * Experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and clinical programs. * Experience preparing for, participating in, and subsequent response to health authority GVP/GCP inspections/partner audits. * Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus. * Ability to write clear quality position statements, risk-based audit reports, and procedures. * Excellent oral and written communication * Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines. * Operational Experience (e.g., PV Operations, Clinical Operations, Data Management), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantage. The base range for this role is $170,000 - $206,000 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. #LI-RM1 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 committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are 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. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight * Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. * Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. * Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. * Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. * Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. * Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. * Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. * Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support * Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. * Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. * Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. * Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting * Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. * Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. * Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness * Ensure the TMF complies with all applicable regulatory requirements and guidelines. * Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. * Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications * Bachelor's Degree Required. * 3+ years of hands-on Veeva Vault eTMF experience required. * 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. * TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies * Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). * Experience in managing TMF documents during audits or regulatory inspections. * Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. * Basic understanding of study and site management and overall trial planning and execution. * Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. * Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies * Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. * Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. * Strong work ethic, organizational skills, oral and written communication skills, a 'can do' approach, problem-solving skills, and team player skills. * Ability to multi-task and manage several projects in parallel while paying attention to detail. * Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

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: * Responsible for leading and developing the clinical drug supply strategy, planning and management of all supply chain activities required to support global Phase I - III clinical studies including forecasting, supply planning, IRT configuration, inventory management and CMO management * Collaborate with the Clinical Development and Clinical Operations teams from protocol development through final study design to have an in-depth understanding of the clinical study requirements and assumptions needed to set up the supply chain required to support the execution of the study and develop the IP forecast * Participate in Clinical Sub Team (CST) meetings, Study Team meetings, Project Team meetings and present Supply Chain updates as required to the Kura cross-functional team * Develop an expert-level understanding of the IRT system used to manage site activation, IP site shipments, monitor patient enrollment, patient visits, determine trends and execute adjustments * Manage extensive internal and external touchpoints and maintain close communication and collaboration to ensure adequate clinical drug supply for multiple global clinical trials while ensuring compliance with cGMP and global regulatory requirements * Responsible for providing commercial supply chain support in collaboration with the Manufacturing, Quality and the Commercial team including serialization expertise, as well as the release and distribution of commercial product from 3PL to authorized trading partners in compliance with the Drug Supply Chain Security Act (DSCSA) * Participate in the creation and maintenance of clinical and commercial SOP's and Work Instructions and related documentation * Lead continuous improvement initiatives in collaboration with the IMSC team, as well as cross-functional partners to document, standardize and streamline core supply chain processes supporting Kura's clinical programs, as well as the commercial supply chain * Support financial planning for global clinical studies including budgeting, forecasting and strategic planning activities Job Specifications: * Technical degree or equivalent (BS/MS), preferably in Supply Chain or IT * 8-10 years pharmaceutical/biotechnology supply chain planning and forecasting experience, preferably in a manufacturing or commercial environment * 3- 5 years of leadership experience in pharmaceutical/biotechnology industry with a proven track record of leading teams and delivering results * Experience managing complex global supply chain operations including vendor partnerships, contract negotiations, while ensuring compliance with cGMP regulations and requirements * Experience collaborating with Manufacturing, Quality and CMO's including providing a 12 - 24 month rolling forecast of drug product requirements, managing production schedules and coordinating FG deliveries * Comprehensive knowledge of CMC requirement/activities including development, validation, regulatory and quality requirements and timelines The base range for a Director is $202,000 - $235,672 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. #LI-RM1 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 committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are 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. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

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 FUNCTION: * Act as the "CEO" for Kura's lead menin inhibitor, ziftomenib, fostering a sense of mission, creativity and urgency. * Lead the Global Program Team: an empowered multi-disciplinary team of leaders * Develop near and long-term strategic objectives and recommendations for the asset across all indications from early to late-stage development and ongoing lifecycle management * Accountable - the single point of accountability for all Global Program Team activities * Define and lead the membership of the core and extended team * Focus on full cross-functional business including clinical development, commercial, CMC, finance, and business development * Extended partnership with global program management, commercial and development functional leads, external partners, and Senior Leadership Team * Work with the team and with senior leaders to define the strategic direction for the asset and plays a key role, driving execution of asset goals, and ensuring alignment and integration among Core Global Program Team and Extended Teams. * Form a close partnership with department leads and with program management to build program plans, identify and mitigate risks, capitalize on asset opportunities, manage budgets, and timelines and ensure best practices. * Represent the program to internal and external stakeholders, including collaboration partners and the Board of Directors. * Lead key program team meetings and serve as a point of escalation for the program to senior leadership. * Help build best practices for efficient and effective program teams. * Support external stakeholders engagement including Health Authorities, potential strategic partners, vendors and and KOLs. * Drive cross-functional collaboration and act as the owner of the Asset Integrated Development Plan * Work with corporate affairs on investor communications to optimize external program communications * Partner directly with the SVP, Global Program Leadership to lead change and evolution of program and portfolio strategy to enhance decision-making, build high-performing teams, and optimize portfolio decisions across programs JOB SPECIFICATIONS: * 15+ years drug development and commercialization experience * 10+ years oncology experience, with preference in heme/oncology * Prior experience with partnered programs (development and/or commercial) will be valuable * Highly visible role focused on cross-functional team leadership, including strategy development, communication and driving tactical delivery of programs * Strategy, Project, Program and Portfolio Management, Talent Development, Mentorship and Alliance Management expertise * Advanced Degree (MBA, MS, PharmD, PhD) * Build trust, transparency, and clear communication plans * Connect strategic vision for asset strategy to the competitive environment and company strategy * Ability to understand and communicate complex scientific and commercial matters while keeping the big picture in mind and the credibility to engage subject matter experts on details at all levels in the organization * Ability to consider and integrate different points of view, new ideas etc.; demonstrates self-awareness and emotional intelligence * Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions and departments The base range for a Vice President is $333,000 - $368,000 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. #LI-RM1 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 committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are 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. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: In this role, you will be responsible for a wide variety of projects across the Commercial organization to include, but not limited to, functioning as the business lead for sales sizing and alignment, field incentive compensation design and implementation, field analytics and reporting, implementation of commercial systems, collaboration with brand marketing/e-marketing initiatives and supporting KPIs for overall performance. Additionally, you will identify critical business issues and opportunities for growth, collaborate with cross-functional teams, and work to embed an external market point-of-view into the strategic direction of the company.Position Responsibilities: Strategic Leadership & Operational Excellence Define and implement a structured framework of goals and tactics to build a best-in-class Field and Sales Operations organization. Establish and maintain robust analytics and operational processes that effectively support the General Managers and Sales organization. Data Governance & Systems Integration Serve on a cross-functional data governance team to define business rules and processes that ensure data integrity and consistency. Partner with Sales and IT to design, deploy and maintain Veeva both in the US and ROW Provide Field Operation Support for ROW Ensure organizational compliance with CRM data standards and quality protocols. Sales Enablement & Field Optimization Train the commercial field sales team on systems, tools, and processes to maximize efficiency and adoption. Develop and refine field sizing and deployment strategies to optimize sales force effectiveness and meet business objectives. Manage territory alignment and roster systems to ensure optimal resource utilization. Manages the field sales force credentialling program Performance Management & Incentives Lead the development and execution of incentive compensation programs aligned with strategic goals, including plan design, governance, goal setting, reporting, and payout processing. Monitor departmental performance against KPIs and collaborate with commercial leadership to drive continuous improvement. Cross-Functional Collaboration & Commercial Readiness Oversee and execute a broad range of commercial initiatives to ensure organizational readiness for product launches. Collaborate across the Commercial team to align operational strategies with key business objectives and priorities. Candidate Requirements: Bachelor's degree in business, science or related field. A master's degree (MBA) strongly preferred. 8-10 years of experience working in the pharmaceutical or biotech industry with five plus years supporting field sales teams. Extensive experience supporting technical design of commercial systems. Implementation experience a must. Extensive experience with Veeva CRM, data management and incentive compensation Experience with Symphony, IQVIA. CROSSIX and related pharmaceutical sales data Experience working with field sales teams, field reporting and incentive compensation Strong analytical skills with the capability to appropriately define issues, questions and data; to comprehend quantitative methods and analytical techniques; to perform accurate analysis (correctly calculated numbers, accurate graphs); to cross-check data and assumptions; to document and establish data trails; and to think creatively about different ways to analyze data and information Excellent quantitative background that supports the analysis of data to better understand market dynamics and provide insights into product performance and marketing strategy. Strong interpersonal skills with demonstrated ability to drive toward consensus. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a strategic and accomplished scientific leader to serve as Head of Biomarker Development. This individual will be responsible for shaping and executing the biomarker strategy across Scholar Rock's pipeline to enable translation from discovery through clinical development in neuromuscular and rare diseases. Reporting to the Vice President, Head of Preclinical Sciences, this leader will design and implement fit-for-purpose biomarker approaches, oversee assay development and data generation, and serve as a key contributor to regulatory submissions, clinical protocols, and program strategy. This individual will be a member of the research leadership team. The successful candidate will integrate discovery, translational, and clinical perspectives to ensure biomarker strategies inform patient selection, target engagement, pharmacodynamics, and disease progression across stages of development. Position Responsibilities:Strategic Leadership & Vision Define and drive the biomarker development strategy across preclinical and clinical programs, ensuring alignment with overall portfolio goals. Serve as a translational science thought leader, integrating biomarker approaches into program strategy, clinical development plans, and indication expansion activities. Represent Biomarker Development in cross-functional governance and portfolio planning forums. Functional & Scientific Oversight Lead the design, development, and qualification of fit-for-purpose biomarker assays (fluid, tissue, imaging, molecular, and cellular). Oversee biomarker implementation in preclinical models and clinical studies, ensuring robust data generation and interpretation. Manage CROs and external collaborators/vendors to deliver high-quality biomarker data. Collaborate with discovery teams to translate preclinical biomarker hypotheses into clinically actionable endpoints. Provide expertise on novel technologies (e.g., immunoassays, LC-MS, SIMOA, RNA-seq, digital pathology, imaging biomarkers, multiparameter flow cytometry). Regulatory & Clinical Integration Contribute to the design of biomarker plans within clinical study protocols, informed consent forms, and statistical analysis plans. Author and review biomarker sections of INDs, CTAs, IBs, CSRs, and other regulatory filings. Present biomarker data and strategy to internal stakeholders, governance committees, external partners, and regulatory agencies. Candidate Requirements: PhD in biology, immunology, neuroscience, pharmacology, or related discipline. 10+ years of experience in biotech/pharma R&D with a strong track record in biomarker discovery and development, including translational application in clinical trials. Demonstrated leadership in developing and implementing biomarker strategies for rare diseases; experience in neuromuscular disorders strongly preferred. Proven expertise with a range of biomarker platforms (immunoassays, LC-MS, transcriptomics, imaging, flow cytometry, digital pathology, and molecular assays). Familiarity with bioanalytical and regulatory requirements for biomarker integration in IND-enabling studies and clinical development. Experience managing CROs, external consultants, and collaborative teams. Strong leadership, interpersonal, and communication skills, with the ability to influence across levels and functions. Passion for rare disease research and a commitment to improving patients' lives. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description We are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical trials. In this key role, you will partner closely with the Clinical Operations Study Lead to manage critical components of study delivery-ensuring timelines, quality standards, and budget expectations are met. You will drive meeting coordination, site and vendor support, documentation management, and quality oversight across assigned studies. This position offers the opportunity to make a meaningful impact on study execution while working with minimal oversight. Key Responsibilities Study Team & Meeting Management (50%) Lead preparation of agendas and meeting minutes for cross-functional study team meetings Support site start-up activities Manage ancillary vendors as assigned Participate in Investigator Meetings, including presenting materials when appropriate Study Documentation, Tracking & Quality (50%) Monitor systems, processes, and vendors to ensure clinical trial data quality; identify risks and recommend improvements Review clinical protocols for operational feasibility and anticipate potential study delivery challenges Draft and maintain clinical project timelines; proactively escalate risks to the Study Lead Support clinical trial budget analysis and cost tracking Track 1572s and collaborate with Regulatory for IND submissions and essential documents Maintain and QC Trial Master File (TMF) documents Assist with creation and distribution of ICF templates, manuals, and other study materials Contribute to the review of core study documents (protocol, IB, CSR) Manage sample accountability and tracking Develop, maintain, and QC study documentation and trackers Perform additional operational activities as assigned Qualifications Required Qualifications Bachelor's or Master's degree with 3+ years of clinical operations experience in pharma or CRO Strong understanding of ICH, GCP, and global regulatory expectations Ability to interpret and communicate protocol requirements Demonstrated experience managing components of clinical trials independently Preferred Capabilities Advanced proficiency with clinical trial software platforms, vendor systems, and related tools Understanding of data-technology interdependencies, vendor metrics, and operational nuances across vendor types Excellent verbal, written, and presentation skills Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $116,800 - $160,600. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness Ensure the TMF complies with all applicable regulatory requirements and guidelines. Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications Bachelor's Degree Required. 3+ years of hands-on Veeva Vault eTMF experience required. 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). Experience in managing TMF documents during audits or regulatory inspections. Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. Basic understanding of study and site management and overall trial planning and execution. Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. Strong work ethic, organizational skills, oral and written communication skills, a ‘can do' approach, problem-solving skills, and team player skills. Ability to multi-task and manage several projects in parallel while paying attention to detail. Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a highly experienced and organized leader to provide global CMC leadership across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. As the Director, CMC Management, you will be accountable for CMC project and portfolio management activities for our products working closely with CMC technical leads and cross-functional CMC teams. This role will require attention to detail, proficiency in forward planning and organizational skills and effective stakeholder management to ensure seamless development of CMC plans for clinical and commercial programs.Position Responsibilities: Provide leadership to develop and maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs Collaborate cross-functionally to effectively monitor progress and drive CMC activities and ensure alignment with overall program goals and timelines Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success Support development and refinement of processes, tools, and systems to deliver high quality project management for the CMC programs Develop and maintain dashboards and organize and maintain documentation for CMC plans for each program Support Regulatory CMC with submission timelines e.g. reviews, approvals within CMC functional areas Champion a winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration Develop global CMC strategy in collaboration with CMC leads and functional teams; Proactively identify issues and drive resolution; anticipating key future events and adjusting team priorities/plans accordingly to deliver high quality results on time. Candidate Requirements: Bachelor's Degree in Science or related field, or equivalent with 12 years of related work experience, or advanced degree and a minimum of 8 years of work experience 8+ years of experience with biologics CMC early-stage, late-stage, and lifecycle management projects Experience in achieving CMC objectives through an outsourced CDMO model Excellent communication and interpersonal skills with the ability to influence and gain consensus across multiple functions, manage a diverse set of stakeholders, and work closely with team leaders Strong analytical, problem solving and critical thinking skills; highly organized. Proven track record of successful project management of complex drug development programs in a fast-paced environment Project and portfolio management certificate or expertise; expertise with project management tools (e.g. Smartsheet, MS Project, dashboards) Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking a highly experienced and technically strong Senior Director of Drug Product Development to lead formulation and drug product development efforts across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. This role will be responsible for driving drug product strategy and execution across modalities and presentations-from intravenous (IV) to subcutaneous (SubQ), including high-concentration formulations, prefilled syringes (PFS), and autoinjectors (AI). The ideal candidate brings extensive experience in setting strategic direction and hands-on leadership of formulation development, process development, tech transfer, and commercial readiness for biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability.Position Responsibilities: Lead end-to-end drug product development for Scholar Rock's biologic assets across all phases-from preclinical development through commercialization. Define and execute robust formulation strategies to support both IV and SubQ presentations, including development of high-concentration (≥200 mg/mL), stable formulations. Lead the development and optimization of vial and of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use. Provide scientific leadership in evaluating excipients, container closure compatibility, viscosity, and stability to support target product profiles and patient-centric delivery. Drive selection and integration of drug delivery devices (e.g., PFS/AI) in collaboration with commercial, clinical, and regulatory functions. Establish phase-appropriate formulation control strategies and support setting and justification of specifications in coordination with Analytical Development. Direct process development activities including fill-finish process design, container closure system evaluation, and scale-up for clinical and commercial manufacturing. Lead technical due diligence, selection, and oversight of CDMOs and technical support for drug product manufacturing. Ensure successful tech transfers, manufacturing readiness, and PPQ strategy development in collaboration with Manufacturing and Quality. Apply Quality by Design (QbD) principles to develop and optimize robust drug product formulations and processes. Partner closely with Analytical Development to define and maintain specifications and support real-time release strategies. Act as the technical lead for DP-related CMC sections of regulatory submissions (INDs, BLAs, IMPDs), including response to health authority questions and engage with regulatory agencies (FDA, EMA, PMDA) to support development, inspection readiness and support. Represent Drug Product function on cross-functional CMC and program teams. Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement. Candidate Requirements: Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ years (or M.S. with 15+ years) of experience in biologics drug product development with emphasis on high concentration biologic formulation for combination product development, particularly with pre-filled syringes and autoinjectors. Deep expertise in formulation development for monoclonal antibodies and other complex biologics, including high-concentration SubQ products. Proven track record in advancing injectable drug products from early development through commercialization including demonstrated success in managing late-stage process validation studies. Experience leading workstreams for PFS/AI combination products, including primary container evaluation, combination product platform technology evaluation, design control process, design verification studies and validation, human factors engineering, and regulatory expectations. Strong technical leadership, project management, and cross-functional collaboration skills. Familiarity with regulatory expectations for DP development and CMC submissions in US and EU. Preferred Experience: Experience with combination products, device development, and cold-chain distribution. Prior leadership of external CDMO partnerships. Experience with QbD-based development and global CMC strategy implementation. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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. Key responsibilities include oversight of outsourced data management & EDC activities by service providers, performing and coordinating internal study team data review, and delivery of fit for purpose clinical data in support of study milestones. ESSENTIAL JOB FUNCTIONS: * Provide clear, consistent communication to Kura's CROs and 3rd party Vendors with respect to data management deliverables and monitor performance against communicated expectations. * Coordinate internal team review and feedback during EDC builds and/or migrations and provide clear guidance to external DM and EDC build team throughout. * Accountable for DM task and milestone timelines * Responsible for ensuring data quality and integrity for clinical study data collection activities. * Work with clinical team to define and maintain the Kura Comprehensive Data Review Plan. * Lead Kura study team in the review of clinical study data per Comprehensive Data Review Plan. * Prepare and provide internal data listings and reports as required. * Review protocols for data collection and management feasibility. * Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out. * Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF). * Review study budgets and provide input on data collection, cleaning, and reporting as it relates to development of vendor contracts * Partner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives. * Responsible for tracking and documenting data management decisions. * Responsible for initiating and chairing meetings associated with assigned studies and initiatives * Provide support and contribute to the development of clinical trial timelines as it relates to data management activities. * Manage accruals tracking and vendor payments for data management activities. * Contribute to the development of departmental procedures documentation. * Complete other duties as assigned by the JOB SPECIFICATIONS: * A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field. * 5+ years' experience in data management or relevant work in the pharmaceutical/biopharma industry. * Experience in oncology strongly preferred. * Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out) * Significant experience providing oversight for database migrations. * Experience with an NDA submission desirable * Strong project management skills * Strong vendor management skills (e.g. Biomarkers, Labs, Imaging, ECG). * Able to provide independent DM subject matter expertise to study teams and vendors in defining, managing, & delivering on DM obligations. * Experience working in 1 or more EDC platforms (Rave, InForm, etc.). * Experience working in a data integration/visualization platform (e.g. Saama, elluminate) desirable * Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines. * Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. * Excellent interpersonal skills in addition to verbal and written communication skills. * Strong Excel skills, SAS experience a plus * Flexibility to travel up to approximately 5% of The base range for a Manager is $157,000 - $179,000 and for a Senior Manager it's $182,000 - $207,000 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. #LI-RM1 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 committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML"). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are 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. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn . Summary of Position: Scholar Rock is seeking an experienced and motivated Director/Senior Director of Pharmacoepidemiology. Reporting to the Head of Drug Safety & Pharmacovigilance, the incumbent will serve as the key subject matter expert within safety and on cross-functional Development and Submission Teams involving epidemiologic analyses. The individual will be the primary point of accountability for the development and oversight of post-authorization studies to fulfill Regulatory Commitments e.g., PMRs, PASS and PAES involving observational study data. Position Responsibilities: Designs, produces and oversees protocols for observational studies using secondary data or primary data collection, including Company-sponsored or other data sources Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents Contributes to Risk Management Plans (RMP, PV Plans etc) for products throughout lifecycle Performs systematic epidemiologic literature reviews and summaries for relevant safety topics Performs signal detection analyses of safety reporting system databases (AERS, Vigibase) using data mining software Actively participates including making presentations at meetings including product safety team and Global Patient Safety staff meetings May supervise 3rd parties e.g., vendors or contract/other staff Supports PV System implementation and maintenance and other Departmental goals and objectives Candidate Requirements: Doctoral degree e.g., PhD or Master's degree in Epidemiology from an accredited institution Minimum of 10 years relevant work experience, preferentially in the Pharmaceutical/Biotechnology industry with a primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submissions and safety Solid knowledge of study methodology in general medicine and clinical practice, evidenced by experience in designing/conducting epidemiology studies, including Registries Strong knowledge and experience in Global Pharmacovigilance guidelines, Risk Management and regulations; knowledge of international PV regulations is a plus Experience with data mining software and applications Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations. Ability to manage priorities, resources, and performance targets, in a changing environment. Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Reporting to the Executive Director of R&D Quality Assurance, the Sr Manager/Associate Director, PV-GCP (Pharmacovigilance-Good Clinical Practice) is primarily responsible for supporting the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for pre and post-marketing Pharmacovigilance activities and will provide QA GCP support to assigned clinical development programs.. The incumbent may also be responsible for supporting relevant processes and programs that ensure computer system assurance (CSA) for applicable clinical/PV systems. The incumbent builds collaborative, supportive relationships and serves as a point of contact for Quality Assurance for PV and other relevant departments including clinical development, trial operations, clinical data sciences, and other stakeholders. Supports and maintains a quality-focused culture and mindset across the organization. Develop collaborative partnerships with PV and assigned clinical study teams/study team leaders to maintain a current understanding of potential areas of quality risk exposure within the context of ongoing clinical studies and across clinical programs as assigned. Ensure compliance with pre and most marketing PV requirements, and GCP activities including facilitating and managing internal and external PV/GCP audits/audit programs, as applicable. Implement and support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment). Assist with the development and tracking of trending and metrics of internal as well as external vendor quality issues. Provide related training on new regulatory requirements and industry practices. Lead and manage PV inspection readiness activities and other key programs as applicable. Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and front room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable. Promote quality and risk management principles (e.g., quality by design, critical to quality focuses, risk assessment and risk ranking, establishment of risk thresholds and tolerance limits) when supporting innovative programs and advancing ongoing clinical programs. Maintain accountability for ensuring risk-based strategies are utilized when managing and mitigating quality issues and supporting clinical studies, ensuring study-specific risk management activities and strategies are utilized consistently across programs. JOB SPECIFICATIONS: BA/BS degree required, advanced degree a For Senior Manager a minimum of 6 years, Associate Director a minimum of 8 years of experience in the bio-pharmaceutical R&D industry with at least 4 years (6 for AD) or more years in a PV/GCP Quality Assurance Pre and post marketing PV experience is required. Minimum 2 years of experience leading teams, projects, programs or direct reports required. Demonstrated experience drafting, reviewing, implementing, and optimizing standard operating procedures (SOPs). Demonstrated knowledge and application of Global regulations and guidance for GVP, and GCP, and an understanding of requirements for validated computerized systems used in clinical trials and PV Experience in the conduct and reporting of internal and external audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to study subjects, data integrity and clinical programs. Experience preparing for, participating in, and subsequent response to health authority GVP/GCP inspections/partner audits. Working knowledge of Veeva (or similar QMS e-system) required. Knowledge of Inspection Management Tools a plus. Ability to write clear quality position statements, risk-based audit reports, and procedures. Excellent oral and written communication Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines. Operational Experience (e.g., PV Operations, Clinical Operations, Data Management), work in both clinical and commercial stage organizations; and/or experience as a trainer are an advantage. The base range for this role is $170,000 - $206,000 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. #LI-RM1 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 committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1 -mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are 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. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The Manager, Study Start-up will serve as an expert across the study start-up, country, and site activation landscape. The Manager, Study Start-up creates project plans for efficient implementation and oversight of appropriate processes, tools, and technologies to accelerate start-up activities while ensuring quality and compliance. This role leads successful study and site activation oversight by removing complexity, conducting proactive risk identification and mitigation, and removing obstacles that may impact study and corporate milestones. The Manager, Study Start-up excels in project management, organizational, and communication skills to clearly share best practices with study teams, CROs, and internal stakeholders across the Clinical Operations organization to deliver consistent application of these practices. Key Responsibilities Drive global study start-up and site activation activities, milestone oversight, and CRO delivery. Support new vendor and CRO identification, evaluation, and selection, including RFP processes, bid defenses, and selection. Support vendor and CRO contract negotiations and downstream changes in scope. Develop and deliver the global study startup plan by partnering with the CRO Study Startup team. Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables, timelines, and performance objectives. Lead development of procedures and tools to enhance internal start-up capabilities and drive efficiencies, including site contract and budget templates. Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving goals. Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts. Collaborate with internal stakeholders to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios, and accurate operational planning. Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of efficient study startup services. Partner with CRO to ensure efficient start-up processes and transparent reporting to deliver best in practice country and site activations. Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues. Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation. Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements. Build and maintain study start-up, country and site activation best practices. Support the recruitment and performance of junior staff; provide guidance for effective prioritization, problem identification and solving resulting in improved strategic drug development operational efficiency. Oversee dedicated TMF Document Specialist in the overall set-up and maintenance of the Trial Master File across trials. Oversee dedicated staff responsible for site budget and contract negotiations. Qualifications Bachelor's Degree in Science or related discipline. Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies, preferably in oncology. Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment. Strong knowledge of GCP and a solid understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements. Significant experience in leading global study start-up and site activation activities is required. Strong knowledge of EU CTIS regulatory processes and timelines. Must have prior experience: Working for or with CROs and cross-functional teams Writing RFPs and managing CRO selection process Reviewing, assessing, and managing CRO and other vendor/service provider SOWs and budgets Reviewing, assessing, and negotiating site budgets and contracts The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

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 FUNCTION: Act as the “CEO” for Kura's lead menin inhibitor, ziftomenib, fostering a sense of mission, creativity and urgency. Lead the Global Program Team: an empowered multi-disciplinary team of leaders Develop near and long-term strategic objectives and recommendations for the asset across all indications from early to late-stage development and ongoing lifecycle management Accountable - the single point of accountability for all Global Program Team activities Define and lead the membership of the core and extended team Focus on full cross-functional business including clinical development, commercial, CMC, finance, and business development Extended partnership with global program management, commercial and development functional leads, external partners, and Senior Leadership Team Work with the team and with senior leaders to define the strategic direction for the asset and plays a key role, driving execution of asset goals, and ensuring alignment and integration among Core Global Program Team and Extended Teams. Form a close partnership with department leads and with program management to build program plans, identify and mitigate risks, capitalize on asset opportunities, manage budgets, and timelines and ensure best practices. Represent the program to internal and external stakeholders, including collaboration partners and the Board of Directors. Lead key program team meetings and serve as a point of escalation for the program to senior leadership. Help build best practices for efficient and effective program teams. Support external stakeholders engagement including Health Authorities, potential strategic partners, vendors and and KOLs. Drive cross-functional collaboration and act as the owner of the Asset Integrated Development Plan Work with corporate affairs on investor communications to optimize external program communications Partner directly with the SVP, Global Program Leadership to lead change and evolution of program and portfolio strategy to enhance decision-making, build high-performing teams, and optimize portfolio decisions across programs JOB SPECIFICATIONS: 15+ years drug development and commercialization experience 10+ years oncology experience, with preference in heme/oncology Prior experience with partnered programs (development and/or commercial) will be valuable Highly visible role focused on cross-functional team leadership, including strategy development, communication and driving tactical delivery of programs Strategy, Project, Program and Portfolio Management, Talent Development, Mentorship and Alliance Management expertise Advanced Degree (MBA, MS, PharmD, PhD) Build trust, transparency, and clear communication plans Connect strategic vision for asset strategy to the competitive environment and company strategy Ability to understand and communicate complex scientific and commercial matters while keeping the big picture in mind and the credibility to engage subject matter experts on details at all levels in the organization Ability to consider and integrate different points of view, new ideas etc.; demonstrates self-awareness and emotional intelligence Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions and departments The base range for a Vice President is $333,000 - $368,000 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. #LI-RM1 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 committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1 -mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are 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. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kura's website at ******************** and follow us on X and LinkedIn. 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. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice