Careers

The VP Clinical Development will report to the Chief Medical Officer and will provide leadership for the clinical team and Elevar drug development programs. The successful candidate will provide medical and scientific expertise on the strategy, design, execution and interpretation of data from late-stage clinical solid tumor programs This leadership role will be responsible for the clinical development function; direct reports include one or more physicians and clinical scientists.

This individual will be responsible for ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies. Duties include primary interactions with investigators, CROs. Other vendors, and development partners, functioning as the medical representative on the integrated project team, and providing medical consultation as needed across the Elevar portfolio of products and studies.

This individual will interact closely with company management. A genuine interest and understanding of the science, desire to work in a highly collaborative organization, and deep passion about making a difference in the lives of patients are essential. This position is 100% remote.

• Provide medical leadership for the clinical development function and for one or more oncology assets
• Lead study team meetings and provide medical guidance to the clinical operations team in the execution of clinical trials
• Evaluate scientific information and new ideas to assist in identifying new research opportunities
• Secure, analyze and report on competitive intelligence related to successful conduct/execution of studies sponsored by other organizations and new data that may impact Elevar programs
• Provide mentorship and development opportunities to others within Elevar
  Responsible for resourcing clinical development programs within functional area
• Responsible for medical monitoring of one or more clinical trials
• Supervise one or more MDs and/or clinical scientists
• Contribute to CDP for one or more assets
• Represent clinical development to executive leadership, KOLs, investigators, regulatory agencies
• Present findings internally and externally (eg, investigator meetings, regulatory agency meetings) acting as a spokesperson for Elevar
• Work cross-functionally with clinical operations, biometrics and data management, drug safety, regulatory, clinical pharmacology, medical affairs, etc.
• Successfully interface with development partners
• Contribute to determining global strategy for development of oncology assets
• Author/review, in collaboration with other Elevar functions, protocols, ICFs, CRFs, CSRs, IBs, DSURs, PSURs, regulatory packages, NDAs, MAAs
• Review and interpret clinical trial data
• Prepare manuscripts, abstracts and presentations for scientific meetings

• MD (or equivalent) required
• Training in oncology required; US fellowship and board-certification preferred
• 8+ years’ experience in oncology clinical development, with experience in small and large pharma
• Direct experience in authoring NDA/MAA
• Global clinical trial experience, including Phases 1 through 3 studies
• Experience supervising other physicians and/or clinical scientists
• Extensive knowledge of oncology clinical drug development, including FDA regulations, statistics, safety, etc.
• Experience in working with small molecule targeted agents; experience with VEGFR inhibitors a plus
• Excellent written and verbal communication skills
• Willing and able to travel, as needed

Kindly email your resume to Ted Phillips. In the subject line please list your name and the role you are applying for.

The Senior/Executive Director Clinical Development will report to the Vice President Clinical Development and will provide leadership for one or more Elevar drug development programs. The successful candidate will provide medical and scientific expertise on the strategy, design, execution and interpretation of data from late-stage clinical solid tumor programs.

This individual will be responsible for ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies. Duties include primary interactions with investigators, CROs, other vendors, and development partners, functioning as the medical representative on the integrated project team, and providing medical consultation as needed across the Elevar portfolio of products and studies.

A genuine interest and understanding of the science, desire to work in a highly collaborative organization, and deep passion about making a difference in the lives of patients are essential. This position is 100% remote.

• Provide medical leadership for one or more oncology assets
• Lead study team meetings and provide medical guidance to the clinical operations team in the execution of clinical trials
• Evaluate scientific information and new ideas to assist in identifying new research opportunities
• Secure, analyze and report on competitive intelligence related to successful conduct/execution of studies sponsored by other organizations and new data that may impact Elevar programs
• Responsible for resourcing assigned clinical development programs within functional area
• Responsible for medical monitoring of one or more clinical trials
  Contribute to CDP for one or more assets
• Represent clinical development to KOLs, investigators, regulatory agencies
• Present findings internally and externally (eg, investigator meetings, regulatory agency meetings) acting as a spokesperson for Elevar
• Work cross-functionally with clinical operations, biometrics and data management, drug safety, regulatory, clinical pharmacology, medical affairs, etc.
• Successfully interface with development partners
• Contribute to determining global strategy for development of oncology assets
• Author/review, in collaboration with other Elevar functions, protocols, ICFs, CRFs, CSRs, IBs, DSURs, PSURs, regulatory packages, NDAs, MAAs
• Review and interpret clinical trial data
• Prepare manuscripts, abstracts and presentations for scientific meetings

• MD (or equivalent) required
• Training in oncology required; US fellowship and board-certification preferred
• 5+ years’ experience in oncology clinical development, with experience in small and large pharma
• Direct experience in authoring NDA/MAA
• Global clinical trial experience, including Phases 1 through 3 studies
• Extensive knowledge of oncology clinical drug development, including FDA regulations, statistics, safety, etc.
• Experience in working with small molecule targeted agents; experience with VEGFR inhibitors a plus
• Excellent written and verbal communication skills
• Willing and able to travel, as needed

Kindly email your resume to Ted Phillips. In the subject line please list your name and the role you are applying for.

The Quality Compliance Manager supports the Quality Compliance function and ensures the strategic plans and objectives set forth by the Director of the Quality Compliance department are met. The Quality Compliance function is responsible for ensuring that the drug manufacturing and clinical trial processes comply with all applicable government regulations and cGxP standards so that the drugs manufactured by our organization meet our standards and that clinical trials produce accurate and credible results. This position is responsible for maintaining and improving the corporate quality compliance system and has oversight to all cGxP activities. This position provides support and guidance to ensure compliance with regulatory requirements as well as maintain and update information to those requirements. This is a remote-based position.

• Assure compliance with the company procedures and cGxP regulations for products and clinical trial studies as they progress through the product/study lifecycle.
• Function as quality compliance representative on internal and external cross functional teams and multi-disciplinary meetings.
• Provide quality compliance oversight for assigned investigations and ensure that investigations are processed through closure in accordance with company procedures and an appropriate impact assessment, root cause analysis and CAPA action(s) have been identified.
• Conducts trend analysis of compliance related metrics such as deviations and CAPAs.
• Maintain the deviation and CAPA system logs.
• Actively participate in effective deployment of the Veeva Quality Management System(s).
• Review and approve internal Quality Management System Documentation such as SOPs, Quality Agreements and Specifications.
• Review and approve external Quality Management System Documentation such as Validation and Equipment Qualification Protocols and Reports, Investigations and CAPAs to ensure compliance to procedures and processes.
• Work closely with internal and external departments to assure compliance with cGxP quality systems and regulations issued by the FDA, EudraLex and other applicable regulatory bodies.
• Perform Internal Audits to ensure inspection readiness of the site, including preparation, execution of the audit plan and create Internal Audit reports and agreement on appropriate CAPAs.
• Assists with regulatory and compliance training.
• Create new SOPs as directed.
• Perform ad hoc quality compliance projects as assigned by management.

• Bachelor’s degree in science, engineering or business discipline or equivalent number of years of experience.
• 5-7 years of experience in the pharmaceutical industry
• 3 years of experience in Quality Assurance Compliance systems
• Investigation and root cause analysis experience in multiple cGxP disciplines
• Experience in authoring, reviewing and/or approving cGxP related documents (Investigation report, CAPA report, SOPs etc.) required
• Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
• Working knowledge of cGxP international regulation requirements (GMP, GCP and GDP)
• Oral solid dosage and sterile injectable dosage form experience
• Experience in both clinical and commercial manufacturing
• Experience conducting supplier and internal audits
• Experience in supporting health authority inspections and/or client audits
• Working knowledge of the Veeva Quality Management System(s)
• Ability to work in a fast-paced environment and adhere to established deadlines
• Strong written and verbal communication
• Strong technical writing skills
• Ability to work independently with minimal managerial oversight
• Experience with international regulations (FDA, EudraLex, HPRA, etc.)
• Time management
• Computer knowledge and skills
• Travel Expectations: Domestic and international travel may be expected
• Physical Demands: While performing duties of this job, the employee may regularly be required to stand or walk for extended amounts of time. The employee must occasionally lift and/or move up to twenty (20) pounds.

Kindly email your resume to Jill Rubin. In the subject line please list your name and the role you are applying for.

This position is responsible for managing company documents while ensuring data integrity and compliance to company record retention policies. Will safeguard and ensure accessibility of company information. Will work with document owners, reviewers, and approvers to move documents through the appropriate workflow. This is a remote-based position.

• Monitors the document edit, review, and approval process with the document owner, reviewers, and approvers to ensure that documents move through the appropriate workflow in a timely manner.
• Store, manage, and track company documents using Elevar’s document management system, networked drive system and paper filing systems.
• Reviews document meta data for completeness and accuracy.
• Communicates with Training Specialist, Quality Assurance
• Scans, images, organizes, and maintains documents, adhering to the company’s document lifecycle procedures.
• Maintains records in accordance with the records retention schedule.

• Associate degree or bachelor’s degree
• 2 – 3 years document control experience in an FDA regulated environment
• Experienced with Veeva document control software
• Computer-savvy and well-versed in Microsoft Office products: SharePoint, MS Word, Adobe Acrobat
• Detail-oriented, dependable, and trustworthy
• Strong interpersonal, communication and customer service skills
• Strong organizational skills
• Self-directed and able to work independently
• Strong time management skills
• Fluent in English (oral and written)

Kindly email your resume to Jill Rubin. In the subject line please list your name and the role you are applying for.

The Director of Financial Reporting is responsible for all aspects of the financial reporting and future Securities and Exchange Commission reporting. The position will oversee technical accounting research related to new and proposed accounting standards. The Director of Financial Reporting also supports and assists with the implementation, maintenance and review of internal controls and corporate policies and procedures. This position will also be responsible for managing financial modeling, budgets, forecasts, and period budget to actual reviews. This is a remote-based position.

• Preparation, accurate reporting and filing of SEC periodic reports such as Forms 8-K, 10-Q, 10-K and Annual Report.
• Assists in the preparation of other SEC filings such as registration statements and DEF 14A.
• Ensures compliance with US GAAP and IFRS as well as SEC and FASB rules and regulations.
• Develops and manages SEC filings related to XBRL reporting.
• Coordinates, directs, plans, and executes the financial reporting component of the external audit.
• Conducts, supports, and assists with the internal audit function and the initial implementation and ongoing SOX compliance requirements.
• Leads all financial research efforts. Analyzes, researches, and concludes on new and proposed accounting, reporting and disclosure standards issued by the SEC, FASB and eventual IFRS and prepare memorandums regarding the Company’s position and impact on the Company.
• Writes, implements, and ensures effective and practical implementation of corporate policies.
• Assists in recruiting, training, and evaluating staff; assists in developing and implementing continued training for professional accounting associates.
• Liaison with finance department, internal legal counsel, and external independent auditors.
• Manages full budgeting process, which includes financial modeling and budget to actual reviews.

• Bachelor’s degree in accounting or finance required.
• CPA, active license status a plus.
• Speaks Korean fluently
• Exemplary communication skills
• Strong and extensive knowledge of SEC Reporting and US GAAP.
• Strong analytical and problem-solving skills.
• Strong attention to detail, demonstrated integrity and professionalism.
• Ability to stay knowledgeable about, research and reach well-reasoned conclusions on technical accounting issues.
• SOX and internal controls experience.
• Ability to multitask and prioritize diverse tasks.
• Excellent project managerial and interpersonal skills. Ability to motivate teams to produce quality materials within tight timeframes and simultaneously manage several projects required.
• Leadership experience in organizing, planning, and executing projects from conceptualization through implementation across multiple internal and external reporting and organizational lines.
• Strategic thinking and leadership experience with an emphasis on relationship management and communication at all levels within an organization. Facilitate and coordinate multiple deadlines, create cohesive teams, and respond quickly to management requests.
• Proven ability to perform under pressure and stress and to adjust plans to meet changing needs and requirements.
• Experience with financial and accounting reporting systems.

Kindly email your resume to Jill Rubin. In the subject line please list your name and the role you are applying for.

In this role, you will assist The General Counsel with a variety of projects including building, executing, and monitoring corporate compliance. This role will start out as a 3-month contract assignment. This is a remote-based position.

• Advise management team on key legal issues in line with the business objectives
• Review press releases, promotional materials and publications for appropriate IP disclosures and potential legal risks
• Serve as legal advisor on business transactions, acquisitions, divestitures, joint ventures, and licensing.
• Act as legal advisor on corporate security filings and compliance with SEC rules, tax matters, etc.
• Respond to legal notices, complaints, subpoenas, etc.
• Support HR in employment law and related matters.
• Advise on intellectual property due diligence in license agreements and other strategic initiatives that involve intellectual property.
• Advise on the drafting, negotiating, and managing of license agreements, joint development agreements and other complex intellectual property agreements and/or transactions.
• Provides general commercial contracting support for the sales and marketing organization, including drafting and negotiating legal agreements with commercial customers (including hospitals, Group Purchasing Organizations, and governmental entities) and service providers.
• Provides legal guidance on compliance with various healthcare and competition laws such as anti-kickback, anti-trust, HIPPA, and Sunshine Act statutes and their implementing regulations.
• Assists in drafting, updating, and implementation of internal company guidelines and training materials regarding contracting processes and ethics.

• Juris Doctorate degree is required
• 10 + years of experience in a corporate legal setting with majority of experience preferably in healthcare/pharma and or Biotech
• Must be an active membership in good standing with a state bar association.
• Experience in U.S. corporate securities filings, public fund-raising experience is preferred.
• Must be a self-starter, energetic, positive, analytical, and able to drive results, and have a proven ability to work as part of a cross-functional team.
• Must exhibit the highest integrity, excellent judgment, and the ability to proactively recognize and effectively communicate legal issues to general management.
• Must be highly motivated and experienced in successfully handling multiple projects with often short deadlines and have the ability to work independently and prioritize responsibly with minimal supervision.

Kindly email your resume to Jill Rubin. In the subject line please list your name and the role you are applying for.

The Business Systems Consultant will serve as primary liaison between Business and Technology teams for system planning, implementation, and maintenance. He/she is responsible for managing and supporting key technology projects and initiatives, conducting analysis of business processes and user requirements, and consults and assists business leaders to execute technical and process-driven goals. He/she will also provide input to the IT Strategy for the functional areas he/she is supporting and will handle application support as needed. This is a remote-based position.

• Proactively seeks out strategic business opportunities for the application of new or existing technology capabilities (across multiple business areas) with high-level business unit executives providing key opinion-leading clients with comprehensive strategic analyses and insights to help them discover strategic uses of technology products and services
• Identifies information required to support the business strategy and leads the development of appropriate information management strategies, developing them as an integrated part of the business strategy
• Analyzes emerging technologies and work with Business and IT Leadership to translate implications of the new trends into an effective technology vision and strategy.
• Develops, leads, train, and/or reviews the creation of information systems strategy to support the strategic requirements of multiple business areas. Identifies the business benefits of alternative strategies. Ensures compliance between business strategies and technology directions. May prepare testing plans to confirm that requirements and system design are accurate and complete
• Investigates and understands capabilities of existing systems and technologies already in use across the business area and similar and interconnected business areas in Elevar
• Accountable for the accuracy of the fit of the proposed business process improvements and the technical solution to the business needs and the information upon which the business justification and prioritization decisions are made. Also accountable for communicating the business need and drivers to development groups to assure the implementation phase can fulfill the business need
• Drives business process transformation and continuous improvement
• Makes recommendations to process stakeholders regarding the correct approach to achieve process improvement objectives including business process outsourcing, application development or adopting business process management (BPM) practices
• Acts as work stream leader from start to finish with accountability for successful solution delivery within area of responsibility. Provides facilitation of decisions and consensus building throughout the organization and project teams.
• Responsible for business need solutioning, including solution design, proposals and end-to-end business process engineering and requirements mapping for supported functional areas.
• Provides leadership over program standards and performance as it pertains to solution design concepts, deployment, and steady state, in supported functional areas.
• Designs and develops IT solutions (integrated process, applications, data, and technology) to business problems in alignment with the organization IT direction and standards.
• Effectively communicates complex concepts and solutions to all levels of the organization including senior executive level, and C-level.

• Bachelor’s Degree and at least 5 years of extensive IT experience supporting multiple business/functional areas
• Experience in Pharmaceutical or Life Sciences industries especially in Computer System Validation
• Strong Business Analysis/Consulting and Project Management experience
• Broad business acumen and a quick learner
• Experience working in a regulated industry
• Expertise in strategic planning, tactical execution, project management, change and process management, and business systems requirements definition
• In‐depth knowledge of the systems development life cycle, client area’s functions and systems, and systems application program development technological alternatives
• Excellent organizational and verbal communication skills; outstanding problem-solving skills and sound judgment
• Ability to resolve complex issues in high stress and high-pressure situations
• Demonstrated written communication skills, specifically, executive presentations, documentation of system design, configuration, and process specifications
• Ability to build relationships, interface effectively with all levels of the organization, including senior executive level, and C-level communications
• Ability to influence across functional teams and manage relationships across multiple cultures
• Encouraging and empowering others to imagine better approaches, create solutions, embrace change and facilitate change to achieve business outcomes.
• Ability to deal with ambiguity, work in a fast-paced environment and willingness to roll up your sleeves to get things done and help where it is needed

• Experience with complex technology platforms such as SAP, Salesforce and Veeva
• Experience managing agile projects/initiatives
• Bachelor’s degree in in Computer Science, Information Technology, or related field
• Master’s degree in Business Administration, Information Systems, Business Analytics, Healthcare or Project Management
• Certified Business Analysis Professional (CBAP) and/or Project Management Professional (PMP)
• Knowledge of GxP systems such DocuSign, and Veeva Vault Suites – Quality, Clinical Operations, RIM, PromoMats, and/or MedComms
• Physical Demands: While performing the duties of this job, the employee is regularly required to talk for extended periods of time and or hear others speak.

Kindly email your resume to Jill Rubin. In the subject line please list your name and the role you are applying for.

As a Business Operations and Platforms lead, you will be responsible for representing one of the key business areas: Quality Assurance, Clinical Development and Data Management or Commercial and Medical Affairs. The position is accountable for ensuring operational excellence by identifying opportunities for continues improvement and the build and maintenance of IT platforms/systems in the assigned business area. The position will also test all new functionality to ensure it meets the business requirements, is properly validated when required, and will conduct training sessions and be the onsite expert on the system functionality for the users.

In this role, you will collaborate with the business owners of the platform, the SMEs, the business leadership, and internal IT partners to ensure customer support, system configuration and implementation, issue management, continues improvements, UAT supervision, new system release/upgrade management and to address the day-to-day system operational needs. In this position, you will help manage all vendors utilized in the creation and maintenance of the platforms utilized in the business area you support. The Business Operations and Platforms Lead will be accountable for the design, working with the business leads, and running of key KPIs/Metric reports and dashboards. Finally, this position will help other business areas in the same fashion as needed and as capacity allows. This is a remote-based position.

• Ensure all business needs of the system/platform from the assigned area are met
• Develop and enforce policies, procedures, SOPs, and guidelines associated with the operation of the systems/platforms assigned
• Create and execute change management and user adoption success strategies with business owner and IT partner based on platform adoption metrics, business priorities and user sentiment
• Conduct impact assessments and create readiness plans for upcoming product releases and other system offerings
• Train on all supported systems and ensure extensive business knowledge of the area of support; Communicate and train user community on all system releases and enhancements; System/Platform expert for the supported business area. “Go To” person for business questions or business issues
• Coordinate and oversee all operational enhancements for assigned systems/platforms
• Oversee and manage all configurations, modifications, and enhancements of supported systems/platforms including ensuring validation, when required, which includes the development and running of test scripts
• Coordinate and oversee UAT process for all assigned systems/platforms
• Escalate and manage issues along with IT partner on assigned systems/platforms
• Manage cross functional teams in support of the assigned systems/platforms
• Align with the business owners to prioritize and continuously improve assigned systems/platforms
• Manage operational support budget for assigned systems/platforms and gain new budget for needed enhancements or systems
• Design, execution, and maintenance of KPIs/Metrics reports and dashboards for assigned systems/platforms

• Bachelor’ degree in information technology, science, or business discipline
• 5 years + experience in the pharmaceutical or Biotech industry
• Proven experience in managing common systems/platforms utilized by pharmaceutical or Biotech companies
• Experience working with vendors
• Significant experience with GxP Systems, Salesforce and/or Veeva platforms
• Experience in developing and implementing new systems/platforms
• Strong business acumen
• Experience in one or more of the key business areas: Clinical Development, Quality Assurance, Data Management, Medical Affairs, Pharmacovigilance, and/or Commercial
• Experience working with internal IT teams
• Strong communication and interpersonal skills
• Ability to influence across functional teams and manage relationships across multiple cultures
• Ability to deal with ambiguity, work in a fast-paced environment and willingness to roll up your sleeves to get things done and help where it is needed.
• Experience working with remote teams
• Project management experience

Kindly email your resume to Jill Rubin. In the subject line please list your name and the role you are applying for.

The Senior Director/Director, Clinical Operations, is responsible for providing strategic, managerial, and execution oversight of clinical trials activities. Provide strong leadership for clinical trial activities. Responsible for deliverables, resources planning, key milestone, timeline development, financial planning/forecasting and budget management, and ensuring that clinical trials are conducted to the highest GCP and quality standards, within agreed timelines and budgets. This is a remote-based position.

• Ensure that resources, personnel, and expertise are appropriately prioritized and deployed to successfully and efficiently meet study timelines and budgets
• Responsible for the selection, oversight and quality performance of CROs, central laboratories, and other key vendors
• Direct and manage CRO interactions, including sponsor oversight of all clinical operations’ functional activities (e.g., study management, monitoring, site management, trial master files)
• Develop and manage the clinical operations budget with a focus cost effectiveness, efficiency, and quality
• Leads Clinical Operations personnel to ensure attainment of established goals and objectives
• Optimize performance and continuous development of direct reports
• Organize and conduct internal leadership meetings to share clinical trial strategies, risk mitigation tactics, and post study lessons and assessments
• Lead cross-functional projects/initiatives
• Authoring and/or oversight of key study document development and implementation as needed
• Monitor and evaluate the Clinical Operations teams performance, and the performance of CROs and key vendors’ outsourced activities
• Provide clinical operations expertise in cross functional meetings and will directly work or manage teams that work closely with overall compliance and quality in accordance with Elevar SOPs, ICH guidelines and GCP best practices
• Ensure inspection readiness of all regulated activities
• Provide technical and strategic expertise to ensure consistent processes, excellence in planning and execution of clinical trials within study timelines
• Promotes collaborative relations with stakeholders, vendors, consultants, and CROs
• Direct and manage all clinical operations activities for assigned clinical trial(s)
• Participate in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate
• Prepare metrics and updates for management, as assigned
• Proactively identify potential study issues/risks and recommend/implement solutions
• Leads CRO/vendor selection process for outsourced activities
• Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
• Contribute to the development, review and implementation of departmental SOPs and processes and participate/lead in other key corporate or improvement initiatives
• Recommend and implement innovative process ideas to impact clinical trials management
• Organize and manage internal team meetings, investigator meetings and other trial-specific meetings
• Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
• Perform other duties as assigned
• Proactively problem solve in a fast-paced environment
• Promotes a high-performance, results-oriented work culture and instills rigor to the selection, development, and retention of talent; promotes a work environment that includes coaching, mentoring, accountability, feedback, and high-performance standards

• Bachelor’s degree or equivalent in a scientific or health care field is required. Master’s degree is preferred.
• More than 10 years or more than 12 years (Senior Director) in clinical or drug development in the biotech/pharmaceutical related experience.
• The ideal candidate has at least minimum of 10 years of clinical operations experience and has a breadth and depth of clinical operations knowledge and is ready to step into a leadership role with Elevar.
• Experience in oncology therapeutic area.
• Demonstrated experience in core and technical aspects of clinical trial conduct, which may include Site, CRO, Pharma, Biotech, and/or IRB related experience.
• Minimum of 8+ years of CRO/vendor management experience
• Expert knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines FDA CFR, PhRMA code, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable international regulations.
• Thorough working knowledge on compliance and inspection readiness.
• Record of successfully completed clinical trials in all phases and multiple therapeutic areas as well as extensive CRO oversight experience.
• A record of active leadership in the preparation of regulatory submissions.
• Able to deal with time demands, incomplete information or unexpected events
• Able to provide clinical operations expertise to clinical development in a specified product area or project
• Travel Expectations: Domestic and international travel may be expected
• Physical Demands: While performing duties of this job, the employee may regularly be required to stand or walk for extended amounts of time. The employee must occasionally lift and/or move up to twenty (20) pounds.

Kindly email your resume to Ted Phillips. In the subject line please list your name and the role you are applying for.

The Associate Director, Clinical Operations, is accountable for developing and overseeing the operational strategy in support of clinical programs which will include being responsible for managing the execution of clinical trials to maintain regulatory compliance and ensuring quality, integrity, and timely delivery of the clinical data. Responsible for managing all operational aspects of clinical studies assigned from initial synopsis through final study deliverables (study set-up, enrollment, conduct, database lock, CSR, etc). This includes collaborating and directing external partners while ensuring a positive and collaborative team environment. This is a remote-based position.

• Clinical Operations Lead for one or more programs including the development and management of clinical study timelines
• Oversee and manage assigned clinical program budget including clinical trials forecasts and review and approval of vendor and clinical site budgets
• Accountable for leading activities in support of clinical protocols from protocol design to final deliverables including review and contribute to the development of clinical and regulatory documents (i.e., protocols, ICFs, CRFs, public disclosures and CSRs)
• Conduct or participate in the assessment, selection and management of CROs, sites, and vendors; may perform site or vendor qualification visits, requests, and review project proposals
• Provide oversight of study and site management through reviews of monitoring visit reports and tracking site metrics and deliverables
• Develop and manage study oversight plans and activities and identify and implement risk mitigation strategies or corrective action plans while escalating as appropriate
• Manage and oversee assigned GCP compliance activities to support inspection readiness
• Manage and facilitates the cross-functional clinical sub-team meeting and presents Clinical Operations in leadership and sub-team meetings as appropriate
• May manage the hiring and development of Clinical Operations personnel, as well as direct their work to ensure all goals, deliverables, and objects are met
• Manage Clinical Operations personnel to ensure attainment of established goals and objectives
• Perform other duties as assigned
• Proactively problem solve in a fast-paced environment
• Promotes a high-performance, results-oriented work culture and instills rigor to the selection, development, and retention of talent; promotes a work environment that includes coaching, mentoring, accountability, feedback, and high-performance standards

• BA/BS degree required with a minimum of 10 years of clinical drug development experience in biotech/pharma industry, including experience in an early development (FIH to proof-of-concept) and late-stage development
• Minimum of 8+ years of CRO/vendor management experience
• Experience in oncology area
• Excellent understanding of ICH GCP guidance, FDA and EMA regulations
• Demonstrated ability work independently, escalate issues appropriately, and to ensure a solution-oriented approach to the identification and mitigation of risks to project milestones, budgets, and quality
• Strong interpersonal skills to build and maintain positive working relationship with cross-functional stakeholders
• Detail-oriented mindset with excellent verbal and written communication skills
• Proven ability to drive for results and support innovation
• Positive can-do attitude and willingness to flex in roles and responsibilities to support the team and program
• Able to deal with time demands, incomplete information or unexpected events

Kindly email your resume to Ted Phillips. In the subject line please list your name and the role you are applying for.

The Senior Clinical Trial Manager is responsible for the execution of clinical trials including study set-up and execution, vendor management and sponsor oversight activities. The Sr. CTM leads the cross-functional clinical trial team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines to include, contracting and management; management of CROs; clinical trial protocols and patient recruitment; risk mitigation plans and assessments and reporting and metrics. This position works primarily with CRO’s and external vendors as well as with various internal team members to drive to completion all study deliverables in a fully compliant fashion. This role will ensure the highest level of data quality and compliance to quality standards and regulatory guidance, proactively identify, communicate and resolve clinical study operational issues; and participate in process improvement initiatives as required. This is a remote-based position.

• Leads the clinical operations team (CRAs and CTAs as applicable) and cross-functional clinical trial team in the planning, execution and reporting of clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory requirements
• Responsible for clinical trial materials (CTM) label review and approval and assisting with CTM forecasting
• Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity escalates study-related issues appropriately in a timely manner
• Obtain and relay key study issues, status updates and other study information to the clinical trial team and management
• Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply and Clinical vendors (e.g., central lab, CROs, imaging vendors) to support clinical trial activities
• Provides input on the development of eCRF design
• Participates in IRT, EDC and ePRO user acceptance testing
• Participates in data cleaning, listing, and report output reviews
• Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
• Manage Clinical Operations personnel to ensure attainment of established goals and objectives
• Direct and manage CRO interactions, including sponsor oversight of all clinical operations activities (e.g., study management, monitoring, site management, trial master files, etc.)
• Work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
• Oversee CRO activity including but not limited to the clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Provides input to DSUR and adverse event reporting, safety reporting and pharmacovigilance requirements required for global clinical trials
• Involved with sponsor oversight of clinical data analysis, clinical data interpretation, statistical analysis and clinical data verification and data integrity
• Direct and manage all clinical operations activities for assigned clinical trial(s)
• Direct and manage the study project plan, including timeline, budget, and resources
• Participate in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate
• Prepare metrics and updates for management, as assigned
• Proactively identify potential study issues/risks and recommend/implement solutions
• Participate in and facilitates CRO/vendor selection process for outsourced activities
• Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
• Participate in the development, review, and implementation of departmental SOPs and processes
• Recommend and implement innovative process ideas to impact clinical trials management
• Organize and manage internal team meetings, investigator meetings and other trial specific meetings
• Review site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
• Participate in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Perform other duties as assigned

• Bachelor’s degree or equivalent in a scientific or health care field is required with 10 plus years of experience. Master’s degree is preferred. 8+ years clinical trial management experience in a Pharmaceutical/Biotech organization. Minimum of 3-5 years of CRO/vendor management experience
• Experience in full-cycle drug development
• Familiar with advanced concepts of clinical research and demonstrated ability to work effectively in a team/matrix environment
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
• Familiarity with advanced concepts of clinical research; understanding of the pharmaceutical industry practices and standards for new drug development; Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, US Food and Drug Administration (FDA), FDA CFR, European and International guidelines, PhRMA code, clinical research ethics, HIPAA and patient privacy laws, EU Directive.
• Clinical Research Associate (CCRA) Certification and Project Management for Professionals (PMP) Certification preferred
• Able to deal with time demands, incomplete information or unexpected events
• Able to provide clinical operations expertise to clinical development in a specified product
  area or project
• Able to travel up to 20% overnight including international travel

Kindly email your resume to Ted Phillips. In the subject line please list your name and the role you are applying for.

The Drug Safety Pharmacovigilance Senior Manager Scientist will work on the Global Drug Safety Pharmacovigilance Team providing strategic leadership and safety expertise for all aspects of Elevar products throughout the life cycle of the medication. The position will provide support for ICF and protocol development, regulatory submissions and responses, aggregate report development, signal detection and risk management, IB, SAPs, protocols, CSRs and other relevant drug development and post marketing documents. This is a remote-based position.

• In collaboration with the PV team, evaluate and manage emergent safety issues on a quarterly basis
• Responsible for reviewing, analyzing and interpreting information from ongoing clinical and post marketing safety reports
• Continuous assessment of ensuing scientific and medical implications
• Make recommendations based on new safety information for both developmental compounds and marketed products to ensure patient safety
• Assist with writing/reviewing aggregate reports including but not limited to the DSUR, PADER, PBRER, IB, RMP, CSRs, INDs, NDAs
• Create and maintain RSI (Reference Safety Information) within the IB
• Schedule and conduct safety review team meetings. Present updated safety data as determined from updated adverse event tables/listings, regulatory authorities and literature for each product at scheduled safety review team meetings
• Prepare and post safety review team meeting reports incorporating safety discussions, safety decisions, signal detection, risk management and product safety literature for report submission to internal and external parties
• Assist in updating drug development documents and plans based on new and emerging safety information
• Attend clinical development meetings as DSPV representative for IB, protocol, SAP, and CSR
• Interface with functional areas within and outside of PV (clin ops, regulatory, data management, medical affairs, corporate partners)
• Train and mentor new PV Scientists

• Advanced degree preferred (MD, Pharm D, MSN, BSN)
• Healthcare provider with 5+ years of clinical patient experience
• Minimum 8 years’ experience in pharmacovigilance and/or drug development
• Minimum 5 years’ experience as DSPV scientist
• Comprehensive understanding of PV process in support of aggregate report submissions, signal detection and risk assessment
• Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis with detailed comprehension of global regulatory requirements for signal detection and risk assessment
• Excellent organizational skills and ability to prioritize individual and team workloads
• Excellent written and oral communication skills including the ability to present to large internal/external groups
• Capability to synthesize and analyze data from multiple sources
• Expertise in pre and post marketing safety
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
• Oncology therapeutic area knowledge
• IND/NDA experience is a plus
• GCP/ICH knowledge
• Ability to utilize Word, Excel and Powerpoint software

Kindly email your resume to Ted Phillips. In the subject line please list your name and the role you are applying for.