Senior Director/Director Clinical Operations Lead

The Clinical Operations Lead is responsible for oversight of one or more Clinical Programs and associated studies within the program. This includes being a member of the Program Team contributing to strategy and operational expertise (planning, implementation, execution and management of both clinical programs and individual studies). Leading the Clinical Program and oversight of internal clinical staff and CROs to ensure studies are executed in accordance with SOPs, timelines and budget.

• Provides the operational perspective to the Clinical Development Plan and to trial protocol design, ensuring that leadership is aware of operational considerations and options
• Experience in successful study initiation through study completion/primary data analysis and in multiple phases of studies (Phase 1-3, 4)
• Expertise in Subject Matter and in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
• Review and provide clinical operations content to clinical and regulatory documents (IND, IB, NDA, MAA, Regulatory Briefing Books etc.)
• Responsible for developing/mentoring clinical operations staff and creating an inclusive and innovative environment where staff and studies/programs will succeed
• Bachelor’s degree or equivalent is required, typically in nursing or scientific field.
• Responsible for operational decision making, risk mitigation, and contingency planning as well as operational efficiency and innovation at the program level
• Responsible for the strategic development of the clinical strategy and plan for execution of clinical studies/programs (i.e. generation of operational timelines, enrollment models, assessment of availability of the patient population, complexity of trial designs etc.)
• Responsible for executing clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and KPTI policies and all applicable procedures)
• Ability to work both at a strategy level as well as hands on as needed for the program
• Review and provide expert clinical operations input to and ensure consistency of clinical documents within program and across as needed (study protocols, clinical study reports, study plans, etc.)
• Represent Development Operations on the Program Team (contribute to drug development strategy, planning, timing, cost projections) at the program level as well as the individual clinical study level
• The Clinical Operations Lead is accountable to deliver data-driven, actionable operational and strategic insights for execution of a clinical development program and all associated studies
• Integral participation in initiatives or advancement strategies for clinical operations
• Proven ability in leading a global team in the management and completion of multiple, complex clinical studies including inspections.
• Responsible for the Clinical Program(s) always maintaining a state of inspection readiness, and act as an expert during regulatory inspections
• Interacts with and influences all levels of management and cross-functional team members to develop strategies and execute plans to achieve program objectives.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
• Must have 10+ years of Pharma-related/ clinical research related experience (and/or applicable work experience) including 8+ years of clinical study/project management, direct experience mentoring/management of CTA/CTMs and having demonstrated a high level of technical and leadership competencies
• Ability to demonstrate successful coaching/ mentoring and people management (remote management experience preferred)
• Leads cross-functional and within function innovation and process improvement initiatives and ensures effective change management within the organization
• Responsible for maintaining Clinical Operations business standards across studies (tracking, reporting, agendas/minutes, etc.)
• Responsible for driving execution of clinical studies in assigned programs on time and on-budget and for proactive issue management and resolution
• Responsible for the development of the cross functional study/program costs for the Program Team, portfolio process, and financial updates
• Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization

At Karyopharm, we live and demonstrate our ICARE values every day!

We are passionately driven in our mission to positively impact patients’ lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!

What We Offer

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), Karyopharmers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development programs, and a variety of reward and recognition programs)
• A fun, collaborative, work environment
• Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment
• Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
• Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), and tuition reimbursement.
• Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
• Cell phone allowance
• A culture of employee engagement, diversity, and inclusion
• This position is eligible for remote/hybrid working arrangement (may work from home/virtually; may also work hybrid on-site-virtual as required/approved by hiring manager.
• In the U.S., the salary range for this position is $175,000 to $300,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors

About Karyopharm

WE ARE COMMITTED TO DE&I

Reporting to the Senior Vice President Development Operations, you will positively impact patients’ when you

The Executive Director, Data Management is a Leadership position, responsible for oversight of Clinical Data Management (CDM). This role supports all clinical development programs including CRO/EDC vendor selection and management, CDM contracts negotiations and management, timelines oversight, CDM department budget maintenance and management, data metrics & reporting oversight, and CDM staffing/resource and retention oversight/management, working closely with internal and external vendors to ensure clean, solid and timely deliverables supporting all clinical data submissions.

• 10+ years Clinical Data Management experience
• Supports the development of request for proposals (RFPs) for external vendor cross functional/organizational contracts. Review external vendor cross functional/organizational contracts and budget for appropriateness to the project when requested
• BS/BA Degree or higher
• Assess and oversee project plans and timelines as well as assign and effectively manage CDM staff to ensure all projects/programs are appropriately prioritized and key goals are achieved in correlation with defined timelines
• Supervisory and leadership responsibilities for all data management and back-end activities supporting Karyopharm clinical programs from Data Management strategy, database start-up through database lock and CSR/submission.
• Strong Knowledge of ICH GCP
• Oversight of build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements.
• Oncology experience (multiple indications)
• Ability to effectively work in a fast paced, fluid environment
• Lead efforts for cross-functional collaboration between DM and ClinOps regarding Monitoring and Data Cleaning activities moving toward real-time data readiness
• Strong verbal and written communication skills
• Establish/update processes and procedures for CDM Department to meet Regulatory requirements and guidelines such as Standard Operating Procedures, Work Instructions, etc.
• Proven experience in managing a team of 10 people or more
• Lead efforts for cross-functional collaboration between DM, ClinDev and ClinOps regarding data entry and review of critical data fields per protocol and ClinDev guidance
• Represent Karyopharm regarding clinical data issues with internal and external parties/partners, CROs and vendors, including global regulatory agencies
• NDA, ODAC and IND proven experience
• Work with Medical Writing personnel in preparation of clinical study reports and other regulatory documents including NDA
• Strong relationship skills
• Ensure inspection readiness in all DM related domains and activities
• Oversee the CDM Team is effectively working with and supporting Clinical, Pharmacovigilance, Programming, Biostatistics, Medical Affairs, CMC, Finance, Contracts, Legal, Quality and Regulatory Affairs personnel in preparation of data deliverables to support Database/IRT Go Live, DSMB/DMC meetings, Development Safety Update Reports, Interim Analyses, Database Locks , ( e.g. statistical analysis plans) and analyses (e.g. safety and efficacy analyses)and investigative brochures and any Ad Hoc deliverable

At Karyopharm, we live and demonstrate our ICARE values every day!

We are passionately driven in our mission to positively impact patients’ lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!

What We Offer

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), Karyopharmers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), and tuition reimbursement.
• Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment
• Cell phone allowance
• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards) – we are partners in prosperity!
• In the U.S., the salary range for this position is $175,000 to $300,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors
• A fun, collaborative, work environment
• Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development programs, and a variety of reward and recognition programs)
• Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends.
• This position is eligible for remote/hybrid working arrangement (may work from home/virtually; may also work hybrid on-site-virtual as required/approved by hiring manager.

About Karyopharm

WE ARE COMMITTED TO DE&I