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The Associate Director, Regulatory Clinical Trials Management, will lead all regional (EU and other ex-US countries) regulatory clinical trial related activities for the ongoing development, registration, and life-cycle management of Imetelstat and future Geron development product candidates. This position leads the successful transition of Geron clinical trials from the EU CT Directive to EU CT Regulation (CTR) and holds supportive responsibilities including, but not limited to areas of regulatory strategy, systems, processes, submissions, and health authority interactions. This individual will report to the Senior Director, Regulatory Affairs. This position is remote based in United Kingdom. Geron has two corporate headquarters in the United States, Foster City, CA and Parsippany, NJ.

Requirements/Qualifications

Key Competencies:

Clinical Trial Regulation (CTR)

• Manages new clinical trial applications through CTR, as well as transitioning existing clinical trials to CTR
• Defines and executes timelines and strategy for successful transition of ongoing Geron clinical trials to CTR
• Acts as Legal Representative and a “Contact Point for the Union” (as defined by EU-CTR Art. 74) on behalf of Geron
• Acts as primary CTIS user role and responsible for setting up new trials in CTIS and other submissions as needed
• Identifies the impact of CTR on Part 1 documents (protocol, synopsis, IB, IMPD, AxMPD, Drug supply labels etc.), and responsible for compiling components of Part 1 documents
• Together with Regulatory Operations ensures that all products used in Geron clinical trials (investigational and auxiliary medicinal products) are registered in the master database the extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
• Understands regional and local requirements and advises the EU Lead on implementation issues pertaining to regional regulatory strategies
• Responsible for the implementation of the regional regulatory strategy, including the regulatory submission plans, in line with agreed business objectives
• Facilitates tactical implementation at the regional level and contributes to effective communications with the regional and global teams on product activities and issues
• Keeps abreast of changing regulatory landscape to deliver knowledge management to the organization. Contributes to a strong knowledge management base.
• Supports additional regulatory projects (e.g., conducting due diligence, supporting regulatory new initiatives) as needed

Regulatory Systems and processes

• Assists in development of regulatory standards and SOPs.
• Undertakes necessary training and can work effectively within Geron regulatory document management systems and processes (Veeva RIM)

Health Authority Interactions

• Participates in the preparation for meetings with regional regulatory agencies.
• Manages communications with health authorities in support of submissions and other communications in association with EU Lead

Submissions

• Responsible for the preparation and provides review and input on documents for submission to regional regulatory agencies
• Contributes to the preparation of registration dossiers and CTA packages
• Works with regulatory team members and functional subject matter experts to build and maintain the content plan for MAA and CTAs, etc. to ensure timely delivery of submission components
• Works with EU Lead and project teams to develop regional marketing approval submission plans and timing
• Oversees management of responses to questions from regional regulatory agencies in a timely manner and in line with the product strategy
• Contributes to the management of product lifecycle submissions (e.g., DSURs, IB, ODD Annual Reports)
• Works effectively with any Geron vendor to successfully execute above activities
• Ensures that appropriate, up-to-date records are maintained for compliance

Regulatory Input Into Other Functions

• Engages Head of Regulatory, regulatory colleagues and representatives from other development functions to enable execution of regional strategies as appropriate

Experience And Competencies

The successful candidate will be able to demonstrate the following:

• A minimum of bachelor’s degree (or equivalent) in a scientific discipline is required; advanced degree (MS, PhD, MD or PharmD) is highly desired
• A minimum of 5+ years of relevant regulatory experience (depending on level of higher education)
• Hands on experience in successful submission of CTA through CTR and transitioning of ongoing studies to CTR
• Breadth of global regulatory affairs experience in drug development and commercialized products (for example, experience in a therapeutic area, multiple phases of drug development), required
• Broad regulatory experience in EU geographic region preferred (experience across all phases of development) with prior global regulatory exposure/experience. Experience with the centralized procedure is also desirable
• Strong working knowledge of regulations and guidelines related to drug development and registration
• Understanding of the impact of laws, regulations, guidance, rulings, and precedents on drug development; knowledge management skill and experience is desirable
• Demonstrated contribution to drug development projects and implementation of strategies is desirable
• Experience and knowledge in regulatory aspects of clinical trial execution and maintenance, and strong understanding of CTR and implementation
• Proven track record of working effectively within a multi-disciplinary team environment within clinical development, particularly phase I-III
• Demonstrated ability to handle multiple projects, excellent verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a matrix environment are required
• Experience in working/leading project teams; demonstrated project management skills is required
• Excellent English verbal and written communication skills
• Able to work flexible hours to accommodate meetings/teleconferences with different time zones Must be available for periodic face-to-face meetings in the UK, which may require travel to London; potential occasional travel may be required to the United States of America

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include Workplace Pension, Life Assurance, Short Term Disability, Long Term Disability, Employee Assistance Program, Private Medical Insurance, Dental Insurance, Travel Insurance and My Perks at Work. Geron also provides regular-status, full-time employees with a generous time off program that includes vacation, sick, holiday, and paid leave for certain life events.

The Oncology Clinical Educators (OCEs) are field-based clinical healthcare professionals (HCPs) who focus a majority of their time (virtual or face-to-face) engaging with external HCP customers. This team communicates peer-to-peer as a trusted partner with Oncology Nurses, Nurse Practitioners, Physician Assistants, Pharmacists, and Community Oncologists/Hematologist Oncologists. Upon request, they provide data and clinical information in a fair and balanced way and will support the safe, effective, and appropriate use of imetelstat, including education on dosing, administration, and management of potential adverse effects. Following approval, OCEs will be responsible for delivering on-label presentations to their HCP customers to ensure their practices are well informed to support successful imetelstat administration from Day one.

OCEs develop territory-specific interaction plans based on Medical Affairs objectives and their HCP needs and collaborate with internal and field partners on appropriate cross-functional account/institution plans and customer centric programs. OCEs partner on training during onboarding and provide approved clinical updates to Commercial partners at territory and region meetings, and train HCP speakers on request.

OCEs must have practiced as a clinician and demonstrate respective clinical expertise, understand territory/regional practice patterns, collaborate effectively with Field Medical Liaisons and cross-functional field-based Commercial colleagues, maintain professional certification/licensure/credentialing in good standing, and execute all relevant activities in alignment with Geron’s Compliance policies and all relevant industry and institutional guidance for interactions with healthcare professionals.

The territory for this region may include IL, WI, MM and surrounding areas.

Requirements/Qualifications

Key Competencies:

• Develops and maintains relationships with appropriate HCP within a given territory to answer unsolicited product and adverse event management related questions. OCEs will use various channels for interactions (1:1, group presentation; virtual, etc)
• Demonstrates proficiency in using available clinical resources and presentations
• Effectively presents information to HCPs and be able to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines, and all Geron policies and directives
• Actively assess treatment patterns in their territory by meeting with HCPs to understand their needs and expertise
• Continuously updates own knowledge of clinical practice guidelines and institutional or organizational pathways, unmet medical needs, clinical trials, and understand the competitive landscape and actively prepare to address educational needs of customers
• Collects and provides meaningful clinical insights to cross-functional partners to be assessed for use in updating medical/clinical/access/patient support plans
• Engage as appropriate with local/regional chapters of professional societies, local/regional patient advocacy groups and patients to support educational needs
• Demonstrates understanding of relevant outcome, value, and access resources as required
• Builds and maintains a territory plan, and actively contribute to cross-functional institution/account plans to advance cross-functional understanding of customer needs
• Contributes to development and delivery of clinically meaningful programs/projects in line with the Field Medical Affairs plan
• As necessary and appropriate, supports the initial and ongoing clinical area and product-specific training and provide key clinical updates to cross-functional partners
• Provides clinical/scientific support as appropriate at local or regional meetings, which may include presenting clinical data, evaluating speakers, or meeting coverage
• Maintains effective and appropriate communication among internal stakeholders while maintaining full compliance with relevant requirements
• Maintains timely, accurate reporting and documentation of all activities with healthcare professionals

Experience And Competencies

The successful candidate will be able to demonstrate the following:

• Advanced degree (PA, NP, MSN, DNP, PharmD), with a minimum of 5-7 years clinical practice experience in malignant hematology/oncology, and a minimum of 3 years of relevant pharmaceutical industry experience
• Demonstrated ability to identify, engage, and educate appropriate nursing, APP, HCP, patient, and caregiver stakeholders
• Responsible for staying current with clinical and treatment landscape trends in malignant hematology and maintaining professional licensure/competencies/certifications/credentials as required
• Possess a thorough understanding of FDA, OIG, HIPAA, PhRMA Code and other relevant ethical guidelines, and ensure compliance with external/internal guidelines and standard operating procedures
• Must be a strong team player who can effectively work cross-functionally in a matrix environment, including collaboration with clinical and commercial partners as necessary
• Demonstrates learning agility, knows Microsoft Office products and virtual engagement platforms, and has expertise documenting interactions with Customer Relationships Management (CRM) tools such as Veeva Interact or Tika Mobile
• Translates scientific/clinical data into an understandable form to help HCPs best serve their patients
• Good communication and presentation skills
• Energetically embraces responsibilities, demonstrates ability to achieve goals
• Has strong initiative, collaborates well as part of a cross-functional team
• Exhibits excellent time management and ability to work independently
• Strong interpersonal skills and ability to establish/maintain/grow professional relationships
• Must be proactive team player, flexible, and be able to work in a high growth, fast paced environment
• Valid driver’s license required in good standing (must pass background checks).
• Professional licensure, certifications, credentials must be active, in good standing, and maintained
• Travel within region up to 75%
• Required travel to medical conferences, team meetings, and other group meetings (will require some weekends)
• This is a remote based position (territory based); candidates must live in territory (relocation is not provided)

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, a 401(k)-retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes vacation, sick, holiday, and paid leave for certain life events.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations.

California Salary Range: $180,000 to $217,000

New York City Salary Range: $195,000 to $215,000

Washington Salary Range: $205,000 to $215,000

The Manager, Commercial Excellence will be responsible for supporting the Commercial Excellence Lead by partnering across commercial and medical affairs teams to enhance our commercial operations ecosystem through data-driven insights and technology-driven solutions. The ideal candidate will have experience in pharmaceutical data, technology, and reporting, to assist with data analysis to drive business insights. The successful candidate will collaborate with cross-functional teams, including sales, marketing, market access, analytics, medical affairs, and finance, to identify opportunities for process improvement, problem solve, and optimize commercial operations both pre-launch and post launch. This position will report to the Associate Director, Commercial Excellence and can be remote, with expectations for travel to Parsippany, NJ headquarter office periodically.

Requirements/Qualifications

Key Competencies:

• Analyzes and interprets pharmaceutical data to provide insights and recommendations to cross-functional teams
• Participates in projects related to sales quota assignment, optimal territory alignment, and sales performance management
• Determines and analyzes metrics to gauge the success of existing processes and, if necessary, develop plans to optimize solutions
• Supports key account management business planning to ensure key performance indicators and metrics are developed that provide the right level of focus on sales initiatives and sales execution
• Maintains field roster and communicates changes to appropriate parties
• Manages sales administration activities vendors and marketing material delivery
• Partners with compliance and legal on field state, jurisdictional, hospital credentialing, and aggregate spend initiatives
• Provides accurate and timely reporting of KPI metrics to field and marketing teams via dashboards and/or reports
• Serves as the CRM system subject matter expert, providing key reporting, problem-solving, and data validation
• Monitors and evaluates commercial performance metrics and KPIs to identify areas for improvement
• Stays up to date with emerging technologies and trends in pharmaceutical marketing and commercial operations

Experience And Competencies

The successful candidate will be able to demonstrate the following:

• Bachelor's degree in Business, Marketing, or related field; MBA preferred
• 3+ years of progressive work experience in commercial operations, data analysis, and reporting sales and marketing experience within the pharmaceutical industry would be a plus
• Experience in market access, pricing, and/or reimbursement, preferred
• Experience in omni-channel marketing, preferred
• Product launch experience, preferred
• Hematology and Oncology experience, preferred
• Strong knowledge of pharmaceutical data sources and reporting tools (e.g., IMS, Symphony, IQVIA, claims, EMR, Lab, 3PL, Specialty Pharmacy, AI/ML Models, Data Aggregation)
• Experience with CRM, ERP, and other commercial technology platforms
• Strong analytical and problem-solving skills required
• Excellent communication and collaboration skills required
• Demonstrated ability to work independently and in a team environment required
• Strong project management skills with the ability to manage multiple projects simultaneously
• Ability to adapt to a fast-paced, dynamic work environment

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, a 401(k)-retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes vacation, sick, holiday, and paid leave for certain life events.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations.

California Salary Range: $90,000 to $100,000

New York City Salary Range: $90,000 to $100,000

Washington Salary Range: $90,000 to $100,000

The Senior Manager, IT Business Systems will oversee the design, development, implementation, and maintenance of Geron’s GxP and Enterprise systems.

This role is hands-on platform/Tech Lead and will partner with Geron's Business and IT stakeholders across multiple initiatives, driving business requirements gathering sessions, focusing on delivering current-state system improvements and future-state requirements, and evaluating/implementing technical solutions contributing to the Enterprise Applications portfolio. This role will ensure investments are aligned with Geron’s corporate objectives and are designed to maximize utility across Geron’s business functions.

This position is remote and will report to the Director, IT Business Systems with an occasional onsite presence in the Foster City, CA office.

Requirements/Qualifications

Key Competencies:

• Leads the assessments, planning, configuration, deployment of Geron’s Pharmacovigilance systems; Individual Case Safety Report (ICSR) and Signal detection management
• Supports and implements solutions for Geron’s Communication Platform (SharePoint Intranet, field force collaboration, HR Hub)
• Be the subject matter expert (SME) and primary administrative support for key systems such as GxP-DocuSign, ComplianceWire, Ace-Inspection, Veeva (QualityDocs, Veeva RIM) and Box
• Provides secondary administration for Statistical computing environment (SAS, SVN, R) and for Contract Lifecycle Management System (Conga)
• Establishes working relationships with Business and IT stakeholders (IT Infrastructure, IT Compliance) to understand requirements (business, technical) and ensure solutions meets the business outcomes
• Assists in validation/system documentation e.g. URS, FRS, Val Plans, test plans and administrative SOPs/WI’s including writing detailed Support guides and solutions (ITSM-Knowledge base)
• Notifies Business and IT Management on all process and system changes including vendor releases, new features, bug fixes, coordinates implementation of the enhancements and provides appropriate end-user training (if needed)
• Supports helpdesk requests/tickets, responds to critical issues during off hours when necessary and acts as a backup for other IT SMEs as required
• The role will be required to support Global users (NJ, UK office) by assisting in team workload and takes on other duties as assigned

Experience And Competencies

The successful candidate will be able to demonstrate the following:

• Bachelor’s degree in computer science, Information Technology, or related discipline
• A minimum of 5 years of progressive work experience within the Life Sciences industry
• Knowledge of FDA regulation and compliance requirements, including 21 CFR Part 11 and other applicable regulations
• Strong customer service background supporting relevant Clinical, Regulatory, PV and Quality applications
• Strong technical expertise and knowledge of Enterprise and GxP applications, including solution development, system integration and reporting tools
• Project Management skills that include the ability to develop project plans, allocate resources, manage timelines, and deliver projects on time and within budget
• Well-versed in FDA regulations, including 21 CFR Part 11 and other applicable regulations that impact the IT applications use in a regulated environment
• Effective communication and collaboration skills (inhouse and Vendor teams) and experience working in a fast-paced environment
• Committed to continuous improvement, including the adoption of innovative technologies and processes that increase the efficiency and effectiveness of IT systems in a regulated environment
• Maintain a competent level of technical understanding of current and future trends in the maintenance of applications in GxP FDA-regulated environments

Benefit Statement:

All regular-status, full-time employees of Geron are eligible to participate in the Company’s comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life insurance, flexible spending accounts, disability insurance, a 401(k)-retirement savings plan, and an employee stock purchase plan. Geron also provides regular-status, full-time employees with a generous time off program that includes vacation, sick, holiday, and paid leave for certain life events.

Salary Statement:

Offered compensation is determined based on market data, internal equity, and an applicant’s relevant skills, experience, and educational background. The salary ranges displayed below are only for those who, if selected for the role, will perform work in the specific locations listed. Please note the employment opportunity is not limited to these locations.

California Salary Range: $165,000 to $180,000

New York City Salary Range: $165,000 to $180,000

Washington Salary Range: $160,000 to $180,000

• Manage semi-monthly payroll for exempt employees in a multi-state environment with consistent accuracy and meeting specified deadlines
• Coordinate with Human Resources department and Finance team members to assure seamless and timely integration of information for payroll processing and reporting
• Prepare journal entries and monthly payroll reconciliations
• Ensure compliance with Company policy and procedure as well as federal, state, and local payroll tax regulations
• Facilitate with process improvement projects related to payroll
• Prepare and process year-end W-2 filings and associated reporting requirements
• Participate in year-end audits, workers compensation audits, 401(k) audits, and regulatory filings (EDD, CA, DE, Census, etc.)
• Address employee inquiries in a timely manner
• Maintain good recordkeeping of all payroll files and sound internal controls
• Assist with stock processing transactions or reporting on an as needed basis

• Bachelor's degree in Accounting, Finance, or related field preferred
• Minimum of 5 years of relevant experience in payroll processing, and related accounting analysis and month-end reconciliations
• Knowledge and understanding of multi-state jurisdiction payroll regulations and federal requirements
• Pharmaceutical or biotechnology industry experience preferred
• Proficiency with ADP Workforce Now
• Experience with GP is a plus
• Ability to work well independently and as a team member in a time sensitive environment
• Unquestionable ethics and discretion when dealing with confidential and sensitive data
• Strong Excel skills
• Exceptional ability to prioritize, organize, and manage multiple projects simultaneously
• Self-motivated and proactive, able to multi-task, and detail oriented
• Strong verbal and written communication skills, as well as effective listening and interpersonal skills

• Use provided resources to strategically map, identify, profile, and prioritize medical experts and healthcare professionals as per the medical affairs plan and goals
• Develop and maintain peer-to-peer collaborations and relationships with key medical experts in the
  lower risk MDS and refractory MF communities.
• Medical expert engagements may include but not be limited to:
  • Emerging data discussions
  • Exploration of areas of unmet medical need
  • Clinical trial interests and activities
  • Capture of medical insights, responding to unsolicited requests
  • Disease, product, and adverse event education
• Provide fair balanced scientific information and education on published Imetelstat data, disease management, treatment landscapes, mechanisms of action, and molecular pathways to healthcare professionals in accordance with company directives
• Support clinical development initiatives including site identification, trial recruitment, registry, and presentation of final approved data.
• Collaborate with physicians on medical affairs initiatives including publications, advisory boards, medical education opportunities, training, and speaker development
• Serve as scientific peer-to-peer resource to external HCP experts and internal stakeholders
• Communicate clinical insights to internal cross-functional partners to inform medical strategy
• Train internal stakeholders and field partners on key scientific and medical topics as appropriate.
• Maintain effective and appropriate communication among internal stakeholders while maintaining full compliance with relevant requirements.
• Generate compliant territory plans to provide needs based, value-added support of the medical and scientific community in-line with company goals
• Maintain timely, accurate reporting and documentation of all activities with healthcare professionals

• MD, PharmD, DNP, PhD; advanced or doctoral degree in science with substantial and relevant pharma/biotech and clinical experience (a minimum of 5 years) in hematologic malignancies, at least 10 years in US Field Medical/Medical Affairs or related industry roles
• Detailed knowledge of clinical medicine, disease management, patient treatment trends, national/regional healthcare and access environment, clinical trial design, and competitive landscape in malignant hematology/oncology
• Must be proactive team player, flexible, and be able to work in a high growth, fast paced environment. Responsible for staying current with scientific and treatment landscape trends in malignant hematology and for maintaining professional licensure/competencies/certifications/credentials as required
• Excellent verbal and written communication skills, an effective presenter to all levels of healthcare professionals and cross-functional partners
• Embraces responsibilities, demonstrates ability to achieve goals
• Exhibits excellent time management and demonstrated ability to work independently
• Strong interpersonal skills and ability to establish/maintain/grow professional relationships
• Experience in a start-up environment preferred
• Must be proactive team player, flexible, and be able to work in a high growth, fast paced environment. Responsible for staying current with scientific and treatment landscape trends in malignant hematology and for maintaining professional licensure/competencies/certifications/credentials as required
• Possess a thorough understanding of FDA, OIG, HIPPA, PhRMA Code and other relevant ethical guidelines, and ensure compliance with external/internal guidelines and standard operating procedures
• Must be a strong team player who can effectively work cross-functionally in a matrix environment, including collaboration with clinical and commercial personnel as necessary
• Demonstrated knowledge of CRM tools, Microsoft Office products, and virtual engagement platforms
• Must be able to travel from airport hub within geography, travel will be approximately up to 75%
• Valid driver’s license required; MVR check will be performed
• Professional licensure, certifications, credentials must be active, in good standing, and maintained
• Required travel to medical and other work-related meetings, with a possibility of weekend requirements