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 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)

The Head of Commercial Operations will be a key member of the Commercial Leadership Team. This role is critical for the successful evolution from a clinical-stage to a fully integrated, commercial-stage biopharma company. Additionally, this person will contribute to the development and execution of the commercial, operational and organizational strategies and plans to optimally support commercial launch readiness. The role will report to the Chief Commercial Officer. This is a remote-based position.

• Assist in building, activating, and optimizing commercial capabilities to support excellence in planning and execution of sales, marketing, market access, patient support, HUB services, 3PL and other functions as required
• Assist in standing up business planning, forecasting, and performance monitoring, reporting and management capabilities that enable leadership to effectively manage the business and achieve its goals and objectives
• Identify, recommend, implement, and ensure that the sales functions have the key enabling capabilities in place to achieve business performance objectives including, CRM/Dashboard, Reporting, Forecasting, Call Planning, and Incentive Compensation
• Partner with IT to ensure systems, databases & applications are developed to meet the needs of the Sales Administration department
• Partner with Supply Chain to ensure alignment with demand forecast, inventory expectations, and overall Ex-Factory shipment expectations
• Assist in developing a world class Commercial Training and Employee Development function to ensure a strong and compliant commercial launch and support the ongoing growth and development of the employee base

• Minimally, a BA/BS; MBA or other advanced degree is preferred
• 15+ years of work experience in the pharma / biotech industry preferred
• Strong commercial understanding including Go-To Market strategies, field Incentive Compensation design & execution, sales, and marketing KPIs and Metrics; strong understanding of sales processes; customer segmentation, customer profiling methodologies, and understanding of how they impact financial results
• Understanding of commercial aspects of Oncology and Rare Disease, including brand management, sales planning and execution, market access, and regulatory environments
• Exposed to new product launches / product management practices with a focus on sales force sizing, targeting / segmentation, etc.
• High exposure to US pharmaceutical market dynamics and competitive intelligence – knowing market trends, familiarity of trends in healthcare, emerging business models and best practices
• Strategic mindset with high degree of creativity and innovation in developing new approaches, processes, and methodologies to enhance commercial operations
• Startup experience is important

Please apply to this position at the following link: Elevar Therapeutics, Inc – Head of Commercial Operations – 22-140 (paylocity.com)

This role will work with commercial leadership and cross-functional stakeholders to set the market access strategy, manage business performance, identify and manage relationships with 3rd parties (e.g., specialty pharmacies, distributors, infusion providers, payors) and lead opportunities to improve performance to better serve patients. The role will report to the Chief Commercial Officer. This is a remote-based position.

• Responsible for developing an integrated account strategy, ensuring patients have appropriate access to the entire portfolio of Elevar Therapeutics products within the US
• Responsible for implementing and being an integral part in the development of Elevar Therapeutics’ market access product strategy working with cross-functional leadership from internal and external stakeholders. Work cross-functionally to help develop go to market pipeline product pricing and market access strategies.
• Establish and maintain intimate, high level “C-suite” B2B customer relationships
• Address needs of decision-makers at account; lead complex cross-functional team to ensure appropriate input from other Elevar Therapeutics teams (e.g., medical, marketing, contracts & pricing, legal, etc.), and work with account team to ensure sales pull-through

• Minimally, a BA/BS and 10+ years in managed care and/or pharmaceutical industry
• Minimum 3 years of experience calling on payer/PBM accounts and negotiating contracts)
• 2-3 years of channel strategy experience, specifically setting channel strategy, negotiation, and management of GPO channel contracts
• Strong work ethic and the ability to foster a culture of collaboration, continuous improvement, and operational excellence
• Strategic account management skill set with extensive experience in strategic tactical planning, execution and negotiation skills with proven track record of success
• In-depth pharma knowledge: including prescribing, regulations, supply chain, managed care, sales, and legal
• Clear understanding of analytics: ability to develop strategies from analytical insights to drive account performance and ability to “ask the right questions” of analytical resources
• Ability to skillfully communicate and negotiate in tough situations with both internal and external customer, while working within an ever-changing managed markets, payer, and corporate environment

Please apply to this position at the following link: Elevar Therapeutics, Inc – Senior National Account Director – Access & GPO – 22-141 (paylocity.com)

The Director of Marketing will be a key member of the Commercial Leadership Team. This person will be responsible for building and leading the Marketing Team, and for leading the company’s first commercial launches in the US market. They will have the opportunity to make a significant impact on the culture, communication, and dynamics of a growing commercial organization. The role will report to the Chief Commercial Officer. This is a remote-based position.

• Lead the refinement and execution of the overall brand strategy, leading all aspects of tactical execution and leading complex cross-functional teams to accomplish brand objectives
• Drive and manage the creation, development, and implementation of marketing strategies and plans, key messages, and promotional activities that increase brand awareness and accelerate profitable revenue growth
• Lead the relationship with the agency of record and other strategic and tactical vendors to ensure strategic imperatives are pulled through and brand objectives are met
• Conduct market analysis to identify risks, challenges, and opportunities
• Cultivate and maintain strong engagement with local and national key opinion leaders (KOLs) within the disease area
• Take leadership role in anticipating and developing training, commercial launch, key account management and sales materials
• Develop programs that build the Corporate Identity
• Create a brand activation strategy and executes on strategic and tactical programs to connect the Corporate Identity to the businesses and products
• Collaborate with Medical Affairs, Legal, and Regulatory in developing branded and non-branded promotional materials

• Minimally, a BA/BS in Business or Marketing
• Eight (8) years’ experience in the pharmaceutical industry, including five (5) years US pharmaceutical marketing, market access or other relevant experience (sales experience a plus)
• Excellent planning and strategy development while executing against tight timelines
• Demonstrated ability to lead without authority and achieve results in a highly matrixed organization
• High emotional intelligence in leading and managing multiple business initiatives and cross-functional relationships
• Understanding of the economics across all settings (community clinics/community hospitals, academic medical centers), as well as the evolving reimbursement environment, consolidation of specialty pharmacy/distributors, 340B Hospitals, ACO’s etc.) and evolution of specialty pharmaceuticals business highly preferred
• Startup experience also valued

Please apply to this position at the following link: Elevar Therapeutics, Inc – Director of Marketing – 22-142 (paylocity.com)

Elevar is seeking a Senior Corporate Paralegal to join its lean but mighty Legal Team. This position will report to the Head of Legal. This position will be involved in a myriad of legal work. This is a tremendous opportunity to join a team that intends to work collaboratively and cross-functionally to support a fast-paced, ambitious organization. You’ll be successful in this role if you are a confident, hardworking, and collegial individual who desires to roll up their sleeves to work to become an indispensable member of a team. As opposed to a traditional role, this role will challenge the individual in it to be a dynamic team player who is willing to tackle “the issue of the day”. This position will provide legal support across the organization. This is a remote-based position.

• Manage the transactional work across the organization, including but not limited to drafting, reviewing, negotiating, and administering the organization’s contracts. The transactional work includes supporting vendor contracts (including Master Agreements, Statements of Work, Confidential Disclosure Agreements, Licenses, as well as other types of contracts).
• Escalate legal issues and risk to the Head of Legal, as necessary
• Administer the maintenance of the Organization’s contract lifecycle management system from a legal perspective
• Assist in different corporate governance and compliance efforts as the organization moves toward commercialization
• Assist in the administration of the Legal Team budget
• Assist the Head of Legal in the support of time sensitive matters, regardless of the legal subject matter
• Accept and autonomously run assignments, tasks, projects, and research as delegated

• Bachelor’s Degree with 8 years; or Master’s Degree with 6 years; or PhD with 3 years
• 4+ years of paralegal experience in a law firm or in an in-house public biotech/pharma company
• Experience in supporting a high volume of diverse contract types related to different subject matters
• Confidence and competence in spotting and raising legal issues and legal risks while willing to propose and drive solutions
• Willingness to accept assignments, tasks, projects, and research while working autonomously to produce high quality, thoughtful work product
• Desire to work as a collaborative thought partner to the business while providing thoughtful advice
• Ability to assist in the thoughtful collaboration with outside counsel

Please apply to this position at the following link: Elevar Therapeutics, Inc – Senior Corporate Paralegal – 22-143 (paylocity.com)

The Medical Science Liaison (MSL) is a field-based scientific expert that strategically supports the scientific and business objectives of Medical Affairs. The MSL is responsible for scientific exchange with Health Care Providers (HCPs) and key decision makers (managed care, payers, formulary committees, etc.) on Elevar products, relevant disease states, and in support of clinical trials. MSLs combine a strong business acumen, disease state knowledge, clinical knowledge and experience, market awareness, and serve as a conduit for Elevar’s scientific data to external customers while providing external market and clinical insights internally to cross-functional teams. The Medical Science Liaison is responsible for Key Opinion Leader (KOL) identification and relationship development in an assigned geographical area. The MSL will be expected to meet regularly with assigned KOLs to deepen the relationship and for scientific exchange on Elevar products, clinical trials, disease states, and current clinical practices. In addition, the MSL will meet ad hoc with other HCPs to answer unsolicited questions related to Elevar products and/or clinical trials. They will also be expected to give presentations and develop external speakers on Elevar products and related disease states. This role requires a seasoned pharmaceutical professional with Clinical Oncology experience in solid tumors and great communication and interpersonal skills. Additionally, the MSL will function as a Clinical Science Liaison (CSL), working closely with Clinical Development physicians and the Clinical Operations team, to support study site identification for new studies and to assist the Clinical Development Team, as requested, to troubleshoot issues as they arise during the clinical trial. This is a remote-based position.

In collaboration with the Vice President (VP) of Medical Affairs, the VP of Marketing, the Chief Medical Officer, and Clinical Development physicians, the Medical Science Liaison is often the scientific representative of the company and is responsible for external communication of scientific and clinical data on Elevar products across the product lifecycle while also bringing key scientific and clinical insights to Elevar.

• Develop, with the assistance of the Senior Director, Medical Affairs and VP of Medical Affairs, and execute territory initiatives including HCP and investigator engagement plans in alignment with the Medical Affairs strategic plans and in support of Clinical Development plans
• Identify KOLs, with assistance from the Senior Director, Medical Affairs, and the VP of Medical Affairs and cultivate professional relationships
• Maintain cross-functional field partnerships allowing for appropriate collaboration with field commercial teams (sales, market access, etc.), and Clinical Development associates
• Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities
• Function as a CSL, assisting the Clinical Development Team in the identification and education of potential clinical trial sites; assist Clinical Development Team, upon request, in troubleshooting issues during clinical trial conduct
• Manage resources, budget, and objectives for assigned territory
• Develop scientific expertise on Elevar therapeutics, related disease states, and the clinical practice for the given products
• Knowledgeable of and follow all applicable laws, SOPs, and guidance documents ensuring compliance
• Communicate scientific content, written and verbal, related to Elevar products and related disease states. Provide scientific training to internal colleagues
• Identify, categorize, and communicate key clinical insights related to assigned disease state and products

• MD, PharmD or PhD in Life Sciences with solid tumor oncology experience required
• 5+ years of related pharmaceutical Medical Science Liaison experience
• Knowledge of clinical research design and GCP in the oncology area
• Demonstrates a strong understanding of clinical research trial design and study analysis including cost effectiveness and other high-level HEOR evidence approaches
• Demonstrates a strong understanding of local healthcare systems, treatment guidelines and decision making
• A combination of experiences at small / start-up biopharmaceutical company and established biopharmaceutical companies is preferred
• Experience with payor groups, market access teams, formulary committees, and treatment guidelines
• Experience launching products, managing territory resources and budgets as a demonstrated self-starter
• Ability to convey complex scientific concepts and information appropriately tailored to the audience (internal staff, physicians, nurses, patient advocacy groups, formulary committees, etc.)
• Team player, able to establish excellent working relationships across functions, including building strong relationships with Clinical Development and Commercial (Market Access, etc.)

Please apply to this position at the following link: Elevar Therapeutics, Inc – Medical Science Liaison, Medical Affairs – 22-144 (paylocity.com)

The Director of Biostatistics is responsible for leading Biostatistics support for one or multiple therapeutic areas to ensure that Company Research and Development clinical programs are designed, analyzed, and reported to support new product development, regulatory submissions, and growth of existing products. This is a remote-based position.

• Provides statistical support for clinical team in design, conduct, and interpretation of clinical trials in establishing and maintaining policies, standards, and procedures
• For assigned clinical development projects, provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements
• Authors or leads the development of all aspects of preparation and execution of SAP to ensure efficiency, accurate, timely and quality outputs and reviews case report forms (CRF) to ensure that protocol objectives are met, and project standards are maintained
• Develops statistical programs or oversees their preparation as needed to perform pre-specified or ad-hoc analyses and prepare data displays, experience with simulation and act as lead company statistician for all global regulatory interactions including filings, written, oral and face to face interactions
• Supplies statistical input for regulatory submissions and in response to FDA/EMA questions and assists with statistical and operational aspects pertaining to Data Monitoring Committees
• Performs and reports study results of appropriate statistical analyses, in collaboration with other relevant scientific disciplines where applicable, to provide appropriate interpretation of data and sound study conclusions
• Maintains currency with respect to FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments in statistics and drug development and become familiar with the disease states and competitors to enhance the level of customer focus and collaboration
• Contributes to developing ADaM standards, specifications, and datasets
• Assists company in the evaluation of Contract Research Organizations (CRO), specifically the biostatistics, statistical programming, and data management functional area and oversees statistical and programming deliverables by CRO (e.g., SAP, CDISC data, Define.xml)
• Ensures all biostatistics activities comply with industry norms, health authorities’ regulations, ICH/GCP guidelines and company SOPs and assist in the development of SOPs and work procedures for biostatistics, statistical programming, and data management

• PhD in Statistics with 10+ years of pharmaceutical or biotechnology Oncology focused clinical trials
• Extensive experience in full-cycle drug development/pharma required; Experience participating in the commercialization of therapeutics is highly desirable
• Significant and demonstrated experience selecting/managing biostatistics CROs and vendors
• Technical knowledge of major statistical software programs and at least one scientific programming language
• Knowledge of CDISC requirements for SDTM and ADaM
• Strong SAS® background including macro development and program validation
• Demonstrated experience leading change implementations using FDA/CHMP/ICH guidelines and Regulatory submission of datasets using CDISC, including development of CDASH/SDTM/ADaM specifications and knowledge on eSub packages
• Knowledge of PK/PD reporting requirements
• Effective in communication and team collaboration with excellent organizational skills and attention to detail
• Able to work independently while exercising initiative, flexibility, and sound judgement and operate in alignment with Elevar’s values

Please apply to this position at the following link: Elevar Therapeutics, Inc – Director of Biostatistics – 22-147 (paylocity.com)

The Safety Scientist in the Drug Safety and Pharmacovigilance Department at Elevar Therapeutics is a key role in a highly visible position within the organization in the Safety Sciences Division. This individual is responsible for two key activities assuring patient safety: signal detection, and the efficient and timely and efficient processing of aggregate reports such as but not limited to DSURs. The signal detection process includes the assembly of the appropriate information, whether from clinical data, epidemiologic data, or toxicology data; drafting of the appropriate documents discussing the data and describing the analysis of the information regarding a potential signal; and then the communication of those documents to the appropriate Safety Management Team (as put forth in the CIOMS Working Group VI Report) and possible escalation within the organization. This paradigm will be followed whether products are in development or in the marketplace. The Safety Scientist will work in conjunction with the DSPV physician (also in the Safety Sciences Division) supporting assigned products. Also, this individual will draft or contribute to the appropriate documentation of the procedures followed in conducting safety surveillance and aggregate reporting either as SOPs or work instructions. Depending on experience, the Safety Scientist may serve as Head, Safety Sciences or may report into the Head of the division. A good knowledge of GCP and appropriate FDA/ICH guidance is expected. This is a remote-based position.

• The Safety Scientist, working with the Safety Officer(s) for assigned products, will drive signal detection and the compilation/analysis of aggregate reports in both clinical safety and post-marketing approval pharmacovigilance settings
• Contributing author to aggregate reports (DSUR, PBRER, PSUR) and IB; may be called upon to lead in the drafting of an aggregate report
• Member of Safety Review Team assessing safety data for safety signals and risk management
• Reports to the Head, Safety Sciences; the candidate may also be considered for Head, Safety Sciences, depending on managerial experience
• Performs routine and ad hoc safety surveillance activities, such as signal detection, literature review and risk management for one or more programs
• Serves as Secretary of Safety Management Teams for assigned products
• Participates in and prepares responses to health authorities
• Reviews and provides input on protocols, statistical analysis plans, CSRs and other clinical study-related documents

• Health care provider (MD, DO, PharmD, DDS, etc.) status preferred, experience acceptable
• Minimum of 5 years working in the role of pharmacovigilance scientist
• Experience working in small start-up environment required; experience working in large pharma preferred
• Strong knowledge of clinical development process
• Ability to prioritize multiple tasks and make deliverables
• Strong knowledge of drug approval process in the US and EU; knowledge of process in Latin America, Asia and Japan preferred
• Experience with working with contract service providers for case processing, aggregate reporting
• Experience with regulatory inspection readiness and company audits; excellent oral and written communication skills

Please apply to this position at the following link: Elevar Therapeutics, Inc – Safety Scientist – 22-148 (paylocity.com)