Careers

The Director of Clinical Quality Assurance is responsible for the GCP Quality Assurance program at Elevar, ensuring clinical trials are conducted in accordance with GCP regulations and ICH guidelines. Clinical Quality Assurance ensures that clinical trial processes comply with all applicable government regulations and GCP standards, so that clinical trials produce accurate and credible results. Primary responsibilities include management and oversight of all quality aspects of clinical trials, including clinical protocols, informed consent forms, clinical study plans, and support for GCP compliance audits as appropriate. Provides project teams and customers quality/compliance guidance that is commensurate with the stage of development while mentoring and developing staff, conducting GCP training, participating in the selection, qualification, and oversight of third party GCP contract service providers, and ensuring development of internal and external audit plans. This is a remote-based position.

• Ensure compliance of drug development activities to applicable quality and regulatory requirements
• Schedule and prioritize workload of staff to ensure timely review and release of clinical documents to support corporate timelines
• Oversee the clinical vendor qualification program including quality agreements and the appropriate change control and coordination of documents to all third-party contract providers and business partners
• Develop and maintain clinical quality procedures to ensure sound scientific input and quality is produced in clinical documents (e.g., clinical study plans, clinical protocols, and informed consent forms)
• Develop and report metrics describing the performance against internal quality measures and status of compliance gaps on a regular frequency to the development leadership team
• Review and approve scientific protocols, technical reports, and other documentation in support of drug development, validation including computer validation activities, and regulatory submissions as appropriate
• Support preparation, coordination, and management of regulatory agency inspections, including sponsoring/monitoring inspections and clinical investigator site inspections
• Support audit program as requested by the Head of Quality Assurance
• Support the administration of the company’s training program by ensuring GCP training is provided to clinical team members
• Supervise, mentor, and develop professional quality staff
• Represent clinical quality at operational and cross functional meetings

• Bachelor’s degree in science, engineering or business discipline or equivalent number of years of experience.
• Ten years of experience in QA systems implementation and management.
• Five years of experience in a QA leadership position
• Firsthand experience of audits by regulatory authorities.
• Working knowledge of quality system requirements
• Demonstrated track record and success in team building skills and people management and leadership.
• Track record of business performance improvement.
• Experience hosting FDA and other regulatory authority audits.
• Experience conducting supplier audits and internal audits.

Please apply to this position at the following link: Elevar Therapeutics, Inc – Director of Clinical Quality Assurance – 22-124 (paylocity.com)

Will assist in the development of regulatory strategies to advance clinical programs, will interact with clinical teams providing regulatory guidance to ensure successful execution of clinical studies and regulatory submissions. Must build and maintain effective communication and constructive working relationships with external collaborators and regulatory authorities will be. This is a remote-based position.

• Management of regulatory aspects of clinical development program
• Accountable for all relevant Health Authority submissions and approvals for assigned clinical study programs
• Assist with implementation of regulatory strategies
• Provide regulatory guidance to clinical teams
• Supervise the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs
• Assist with mentoring junior regulatory team members
• Understand and be able apply comprehensive understandings of clinical regulations and guidelines (FDA, ICH) for improvements of regulatory success and compliance

• Bachelor’s degree required with minimum of 8 years in pharma industry, and drug development experience in Regulatory Affairs
• Advanced degree in Biological Science and 5 years pharma industry in Regulatory Affairs
• Solid understanding of drug development process and regulatory requirements required
• Ability to understand and help interpret sophisticated scientific issues as it relates to regulatory requirements and strategy.
• Experience in oncology/rare-diseases drug development a plus
• Advanced scientific related degree a plus
• Experience filing INDs, CTAs, and/or NDA/BLAs to FDA and outside US regulatory agencies a plus
• Knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus
• Able to work well with others and communicate with senior leadership
• Strong oral and written communication skills, and negotiation skills
• Willing to set and drive aggressive project timelines
• Capable of strategic thinking and proposing solutions to regulatory problems
• Must be proficient in Microsoft Word, Project, PowerPoint, and Adobe Acrobat
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner

Please apply to this position at the following link: Elevar Therapeutics, Inc – Associate Director, Regulatory Affairs – 22-126 (paylocity.com)

In collaboration with the Clinical Development Lead, as well as other program functional area leaders, the Medical Director will support the clinical development program teams responsible for study design, development, execution, data readout, and summary. This position will also provide ongoing input into assessment and interpretation of safety data and contribute to investigator training. This is a remote-based position.

• Providing medical/clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical development, and clinical operations.
• Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
• Collaborates with external opinion leaders and Principal Investigators, as well as internal clinicians, clinical scientists, translational scientists, and clinical operations personnel to ensure appropriately designed studies are successfully implemented.
• Serve as Medical Monitor, responsible for the medical monitoring of clinical trials, and as medical expert for Phase 1-3 studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.
• Directs the planning, preparation, writing and reviews of aggregate medical safety reports in coordination with the program’s Pharmacovigilance/Safety
• Works with study and program teams to achieve program goals and provides deliverables in approved timeframes.
• Supports the development of regulatory documents for filings and agency meetings
• Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
• Participate in preparation of prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
• Remains up to date with current information on pharmaceutical regulations, guidelines, and practices, as well as therapeutic area knowledge to ensure consistent best practices across all activities including maintaining knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing

• MD degree with oncology experience preferred.
• Experience with medical monitoring in clinical trials
• Preferred 5+ years of broad experience in industry/drug development and/or clinical research with oncology (preferred) therapeutic area.
• Ability to work with a high level of autonomy/independence
• Strategic abilities and capability to take the lead and “ownership” of programs within specific indication areas
• Ability to analyze and interpret clinical safety and efficacy data and develop written reports and presentations of those data
• Strong oral & written scientific communications skills
• Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings)
• Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships and work successfully in a cross functional team
• Ability to travel up to 20%, including international travel

Please apply to this position at the following link: Elevar Therapeutics, Inc – Medical Director – Clinical Development – 22-131 (paylocity.com)

The Principal Clinical Data Manager (PCDM) leads the data management components of clinical trials with demonstrated subject matter expertise in all aspects of the Data Management (DM) discipline. The CDM is responsible for ensuring study launch, conduct, and closeout are performed according to company quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. The PCDM is responsible for overseeing the start-up, execution, and closure of Elevar clinical trials whether outsourced to CRO or in-house, to ensure data quality and integrity. The PCDM will act as a primary data management liaison with vendors and senior management. The individual will oversee and perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions. The PCDM will report to the Head of Clinical Data Management.  This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed. This is a remote-based position.

• Maintain effective communication with vendors and client’s internal project team through oral and written correspondence, project status and progress reports.
• Manage the interaction with data management vendors to ensure that data management tasks remain on target according. These DM tasks include but are not limited to: protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope
• Ensure the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials
• Provide ongoing operational oversight and support for Electronic Database Capture system activities during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications
• Provide ad-hoc report development, and support database lock and archiving activities.
• Oversight and management of cross-functional collaboration, development, and maintenance of all CDM documentation components, i.e., the study Data Management Plan (DMP) and data management deliverables including the Electronic Case Report Form (eCRF), eCRF completion guidelines, annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, data quality plan, Interim/Final database lock list/approval, etc.
• Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
• Ensure project documentation is being archived in a timely manner into the Trial Master File
• Participate in the development of standard operating procedures (SOPs).
• Mentor junior staff on clinical data management activities and procedures.
• May lead or participate in initiatives to streamline data management processes.

• Education preferences or requirements – Minimum of Bachelor’s Degree in science or health related area required
• Minimum of 10 years’ data management experience in pharmaceutical or biotechnology; prior oncology experience required
• Experience with multiple Electronic Data Capture (EDC) process and platforms such as Medidata RAVE, Medrio, etc.
• Demonstrated proficiency with ICH, GCDMP, and GCP is required
• Previous experience managing/oversight of CRO vendors
• Demonstrated problem-solving abilities and strong presentation, documentation, organizational, and interpersonal skills, as well as a team-oriented approach, are required
• Must be computer savvy and highly proficient in Microsoft Office
• High attention to details and accuracy; ability to work independently and to prioritize and organize work to meet deadlines
• Possess effective written and verbal communication skills, interact professionally with personnel at all levels within and external to the company, and be dependable and a team player.
• Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be capable of working under deadlines.
• Capable of working on multiple projects simultaneously, independently manage responsibilities according to deadlines, and define tracking tools to manage projects.
• Experience in solving extremely complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements

Please apply to this position at the following link: Elevar Therapeutics, Inc – Principal Clinical Data Manager, Clinical Data Management – 22-135 (paylocity.com) 

The Director Analytical Sciences serves as the responsible leader with oversight of analytical chemistry in support of progressing Elevar’s development pipeline and ensuring sustained product supply.   He/She will provide strategic guidance on short- and long-term planning as well as technical insight in the selection and implementation of appropriate analytical methods. The role will involve significant collaboration within the CMC group as well as cross functionally with regulatory, quality, and external partners. This is a remote-based position.

• Provides scientific and technical leadership in respect of Analytical Development for projects at various stages of the drug development life cycle
• Leads or contributes to the strategy, planning, execution, and progress reporting for development projects
• Manages activities which include analytical method assessment, development, transfer, validation and troubleshooting for drug substances and drug products, reference standard management, and stability program oversight
• Provides detailed review and approves protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification
• Works closely with external CRO/CDMOs collaborators to c advance method development, qualification, transfer, and validation for API and DP for advanced programs
• Identifies, evaluates, selects, and develops relationships and actively manages external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts
• Ensures processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines, and procedures

• Master’s degree in analytical chemistry or related field with at least 10+ years, or a Ph.D with a minimum of 8+ years of experience, with increasing responsibility
• Extensive technical experience in analytical testing, method development and phase appropriate qualification/validation, characterization, and support of stability programs for small molecule drug substance and their corresponding drug product
• A broad understanding of cGLP/cGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with respect to pharmaceutical product development and manufacture
• Excellent interpersonal and communication skills (written and oral), including the ability to effectively and accurately present data to peers, management, and external partners
• Direct experience in authoring of analytical and stability sections of NDA, MAA, IND and IMPD
• Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities
• Strong ethical standards, with the ability to speak up, identifying critical risks and gaps while providing appropriate mitigations/solutions
• Provide a positive approach to Elevar’s workspace, while fostering an inclusive and collaborative environment

Please apply to this position at the following link: Elevar Therapeutics, Inc – Director Analytical Sciences – 22-136 (paylocity.com)

The Senior Director, Supply Chain serves as the responsible leader with oversight of Elevar’s development and commercial supply chain.   He/She will manage the supply chain group and its deliverables to provide a reliable and secure source of supply through optimization of production/capacity planning, customized inventory vs demand management, and realization of financial efficiencies.  This is a remote-based position.

• Develop and align the global supply chain strategy to the company’s short- and long-term goals
• Ensure clinical and commercial supply agreements are aligned with Elevar’s business needs
• Coordinate with CMO’s and production facilities in establishing manufacturing deliverables and utilization of appropriate metrics to track progress against set goals
• Ensure processes and resources are effectively and efficiently utilized to provide a continuity of supply for all products, making sure that product output and materials input are managed to minimize risk and maximize value
• Routinely collaborate with key Elevar stakeholders to achieve cross company alignment with respect to product supply risk and upside, inventory management through all downstream modes, and financial requirements/spending
• Provide oversight on all relevant product launch activities including coordination of the financial vs physical supply chain and management of key vendors to ensure an efficient and successful commercial launch
• Manage in-line product supply to achieve COGs target, optimization of the supply chain logistics (import/export, tax/duty, etc.) and providing exemplary customer service

• PhD with 7+ years relevant experience, MS with 10 years, or BS with 15 years in Supply Chain/Operations or life sciences/health-related preferred
• 10+ years’ experience as a pharmaceutical supply chain manager/leader, with increasing managerial-leadership experience including launch of new products and sustainability of in-line products
• Demonstrated experience in cross functional team leadership, project management, external relationships, and financial acumen
• Knowledge and experience in working with contract organizations utilizing Good Manufacturing Practices (cGMP) / Good Clinical Practices (part of GxP)
• Extensive knowledge of supply chain processes and systems, network design and management, logistical coordination, warehousing and transportation planning and management
• Experience with enterprise management systems and working with 3PL’s
• Good understanding of Pharma Quality and Regulatory framework
• Strong verbal and oral communication skills with experience in providing executive presentations
• Ability to work independently, lead teams in a strategic and tactical manner while working in a matrix environment with different pulls and levers

Please apply to this position at the following link: Elevar Therapeutics, Inc – Senior Director, Supply Chain – 22-137 (paylocity.com)

The Senior Medical Regulatory Writer will provide expert, hands-on medical writing and QC support for the programs and efforts of the Drug Development group. This role advises on, develops, and authors (and/or supervises external authoring) clinical and nonclinical documents for regulatory submission from pre-IND through NDA/MAA, as well as other documents for technical/scientific publications. This individual will build and maintain strong working relationships with the Clinical Development, Regulatory Affairs, Nonclinical, Global Safety, Biostatistics departments and external collaborators. This is a remote-based position.

• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and publications to medical journals
• Manage external medical writers as needed
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Mentor new medical writers and other members of the project team who are involved in the writing process

• At least 3 years of previous experience in the pharmaceutical industry, focused in Oncology
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial clinical study protocol + clinical study report experience, as lead author, required & understanding of clinical data
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Experience with orphan drug designations and PSP/PIPs is a plus

Please apply to this position at the following link: Elevar Therapeutics, Inc – Senior Medical Regulatory Writer – 22-138 (paylocity.com)