AB

Abeona Therapeutics

- NASDAQ:ABEO
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# Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
1 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Chief Medical Officer (CMO) Open New York NY USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. Abeona is looking for a Chief Medical Officer to join the executive team.   Key Responsibilities: Responsible for the strategy, direction and execution of the company’s clinical development plans  Key member of the senior management team as a member of the company’s Executive Committee which determines and oversees research and drug development at Abeona and sets the overall strategic direction of the company  Managing and maintaining strong, effective relationships with our global vendors, consultants, investigators, and other external clinical trial participants to ensure that the primary goals of the clinical development programs are met  Responsible for representing the company with potential investors, regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of the company's product portfolio  Managing medical strategy, questions, and internal and external relationships that are related to our clinical programs  Monitoring/analyzing clinical trials for safety and, when appropriate, efficacy, and working in conjunction with external Drug Safety vendors to insure timely reporting of safety signals to regulatory authorities  Provide cross functional team leadership for clinical development, medical affairs, clinical operations, clinical pharmacology, etc…  Leading submission of essential documents to the TMF and Regulatory Department, as necessary;  Managing and coordinating deliverables, per vendor and CRO contracts, to ensure project deliverables are met on time and within budget  Reviewing and contributing the necessary templates and documentation (i.e., manuals, guides, communication plans) for each clinical study  Assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)  Communicating in a timely and effective manner with executive management and others, including the board of directors on clinical trial status and activities  Conduct investigator meetings and lead site initiation visits with clinical trial investigators  Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets  Translate findings from research and nonclinical studies into clinical development opportunities  Interact with clinical investigators, thought leaders, and patient advocacy groups  Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines Professional Experience/ Qualifications:  M.D. or M.D./Ph.D. Minimum of 10 years of biotechnology or pharmaceutical related experience in a clinical development leadership role  A mix of corporate and academic experience although the time spent in a corporate setting must be both significant and have been proven impactful Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment  Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies in Rare Disease indications  Documented success in advancing therapeutic programs through clinical trials  Highly skilled in delivering programs and protocols that meet company specified targets and project objectives  Experience in the areas of Rare/Orphan Disease is required. Experience in Metabolism, CNS, Dermatology would be a plus.  Gene Therapy experience would be preferred  Experience working at a publicly traded biotech/pharmaceutical company  Must be a highly effective communicator who is able to establish collaborative internal/external working relationships, present ideas clearly and be perceived by others as approachable and accessible  Proven ability to think strategically and demonstrate expertise in developing and implementing policies and clinical development strategies and plans.  Self-starter who works with a sense of urgency and functions as a strong team player effectively working with and leading other disciplines  Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, investigators, and patient advocacy groups  Ability to communicate and work independently with scientific/technical personnel  Ability to think critically, and demonstrated troubleshooting and problem solving skills  The ideal candidate is a motivated self-starter passionate about working in a fast-paced small company environment  Patient focused, passionate about science an excited about having fun while working hard  Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of Abeona Therapeutics Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
2 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Associate - Early Process Development, Vector Screening and Scale Up Open Cleveland OH USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.  The successful candidate will be responsible for the weekly screening and lab scale expression and purification of novel AAV vector candidates provided by R& D which is critical to support our clinical Gene Therapy programs in neurological, lysosomal storage disorders, and other gene therapy indications. Responsibilities: Support the vector needs of the R&D team with small scale production and purification of AAV vectors Maintain impeccable records from raw data including lab notebooks, log books and computer generated data files Precisely follow laboratory protocols and adhere to work training – safety, process, quality. Note any exceptions or deviations when working with novel vector constructs regarding expression, purification or growth trends. Accurately interpret experimental data, perform statistical analysis, formulate conclusions and communicate data with Process Development colleagues and cross-functional teams Develop new small scale processes as appropriate Serve on departmental and inter-departmental teams Assist in regular lab management tasks such as inventory control, ordering, cleaning, waste disposal, calibration and equipment maintenance. Qualifications: BS or equivalent in scientific discipline and min of 0-2 years related lab experience – an Associate’s degree with relevant experience may be acceptable General biological lab experience Experience with mammalian and/or insect cell culture technology (i.e. aseptic technique)  Experience with the purification of proteins or viruses or viral vectors Experience with analytical methods such as kinetic or binding assays (ex. ELISA) and cell-based functional assays GLP experience Work within a team structure and on individual projects Excellent oral and written communication skills Demonstration of detailed record keeping and data documentation Strong inter-personnel skills Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
3 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Staff Accountant Open Finance New York NY USA Abeona Therapeutics is looking for a Staff Accountant. Reporting to the Controller, Staff Accountant will be responsible for all aspects of company’s accounting and finance activities.   DUTIES AND RESPONSIBILITIES: · Assists with all accounting functions including but not limited to accounts receivable, accounts payable, general ledger, fixed assets, payroll, and purchasing. · Assists with the implementation of accounting systems, policies, and procedures. · Prepares, analyzes, and reconciles all financial statements and related reports including but not limited to balance sheets, income statements, cash-flow reports, budgets, and variance analysis. · Prepares specialized analyses in support of all business functions. · Assists with all budget and forecast process activities.  · Identifies problem areas and takes corrective actions. · Assists with special projects as required.   QUALIFICATIONS: · Bachelor’s degree (B.A.) or equivalent. · Two to four years related experience and/or training. · Basis knowledge of all aspects of accounting, forecasting and financial reports. · Ability to work with all levels of management. · Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow. · Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.   · Commitment to excellence and high standards. · Excellent written and verbal communication skills. · Proficient in Excel, Word, PowerPoint, Outlook. Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
4 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Manufacturing Associate Open Manufacturing Cleveland OH USA Company Overview Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.  Abeona is looking for a Manufacturing Associate to join our team in Cleveland, OH. The successful candidate will be responsible for cGMP manufacturing and working independently and with others on aspects of product development.  Also performs GLP quality control assays.​  Maintenance /​ monitoring of cGMP facility and cGMP/​GLP training as well as specific training in all processes and assays.​ Essential Duties and Responsibilities Performs cGMP manufacturing processes as Verifier and an Operator Writes and executes BPRs, SOPs, study protocols, and authors detailed study reports making detailed observations, analyses, data interpretations and conclusions Instructs co-workers on scientific techniques Maintains ongoing training/education by attending internal training sessions, workshops, external meetings Qualifications Bachelor’s degree in biology, chemistry, engineering or related field. 2 or 4 or more years relevant experience. Demonstrates ability to plan / execute experiments to address technical problems or to  advance a project Note: The required time of relevant experience is a guideline only. That is, quality of work and level of responsibility taken on weigh heavily in determining the appropriate level for an Abeona employee. Other Skills and Abilities Less than 5% travel under normal circumstances to attend training or scientific meetings. Any travel will be reimbursed in accordance with company policy. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 30 pounds is required. Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
5 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Quality Assurance Specialist Open Cleveland OH USA Company Overview Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.  Abeona is looking for a Quality Assurance Specialist to join our team in Cleveland, OH. The successful candidate will be responsible for the weekly screening and lab scale expression and purification of novel AAV vector candidates provided by R& D which is critical to support our clinical Gene Therapy programs in neurological, lysosomal storage disorders, and other gene therapy indications. Position Overview The Quality Assurance Associate performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH.  Maintain the quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing activities, primary and secondary packaging, label control, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management, and regulatory compliance.  The QA Associate will report to the Associate Director of Quality Assurance and will support manufacturing as the production area Quality Assurance representative. Essential Duties and Responsibilities Position is Day Shift with weekends (only as needed) Control document lifecycle activities, including biennial review of procedures and document retention. Process document control requests and issue controlled forms, logbooks, notebooks, master production records, and protocols. Work with the Manufacturing Department as a production area Quality Assurance representative.  Key areas of collaboration include but are not limited to; calibration and preventive maintenance process monitoring and inventory control monitoring. Coordinate and facilitate QA-related production and production-related activities. Review batch-related documentation and ensure resolution of issues to release product. Ensure that products are manufactured in compliance with regulatory and GMP guidelines. Compile and verify all batch-related documents into a final product lot disposition package. Communicate lot disposition pending issues to management. Gather metric information for use in continuous improvement of areas of responsibility.  Report to management as needed. Perform other duties as required. Qualifications Bachelor’s degree in Biological Science or related field. Minimum of one (1) year quality and/or manufacturing experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment. Working knowledge of quality systems and ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards. Effective interpersonal, verbal, and written communication skills. General knowledge of aseptic manufacturing processes. Excellent organizational skills, attention to detail, and Good Documentation Practices. Proficiency in MS Word, Excel, Power Point, and other applications. Ability to communicate and work independently with scientific and/or technical personnel. Must possess effective communication and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management. Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching.  Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.  A normal range of hearing and vision correctable to 20/20 is required.  Occasional lifting up to 20 pounds is required. Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
6 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Quality Control Associate - Microbiology Open Quality Control Cleveland OH USA Company Overview Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.  Abeona is looking for a Quality Control Associate, Microbiology to join our team in Cleveland, OH. The successful candidate is a key part of our growing QC Team and will be primarily responsible for sampling and analysis in support of commercial product development and manufacturing.  You will perform internal facility environmental assessments to confirm the facility is under control and within specifications. Coordinate all metrology testing whether performed in house or by a third party. Essential Duties and Responsibilities Works on QC tasks of varied scope, including work related to environmental control and raw materials management Demonstrates understanding of QC principles and GMPs. Execution of USP/NF or relevant other safety / release assays Equipment/instrument standardization and calibration, as required for testing per SOP’s  Assists in validation/qualification of laboratory methods and manufacturing processes Provides input to improving QC systems and procedures to improve GMP. Complies with company documentation practices (GDP). Reviews and revises specifications for raw material, packaging components, drug products, and reference standards. Reviews and revises analytical methods, SOPs, test records, and CofAs Supports laboratory investigations related to test failures, discrepancies and deviations. Coordinates raw material sampling, inspection, and release as required Coordinates sample results received from external laboratories Supports maintaining laboratory in inspection readiness state. Performs other duties as assigned by management. Qualifications BS or BA in Microbiology or Biological sciences and a minimum of 3-5 years of basic laboratory experience Experience and knowledge in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP and/or GLP environments Must have experience with basic microbiological techniques Must be able to perform sterlie gowning as required in Production and QC Laboratory areas Must be familiar with basic aseptic techniques and requirements Knowledge of GMPs, GLPs safety, proper documentation, and data integrity is preferred Ability to interact constructively with co-workers Physical Demands A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 25 pounds is required. Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
7 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Senior Associate, Regulatory Affairs Open Regulatory Affairs Cleveland OH USA Company Overview Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.  Abeona is looking for a Sr. Associate, Regulatory Affairs, to join our team in Cleveland, OH. The successful candidate will report to the Associate Director, Regulatory Affairs and will primarily be responsible for assisting in the development and submission of US regulatory filings. These include investigational new drug applications, designation requests, meeting packages, and annual reports for multiple therapeutic programs. Essential Duties and Responsibilities Devise and implement regulatory strategies under the direction of senior management. Develop and publish documents for regulatory submissions. Prepare submissions in electronic Common Technical Document (eCTD) format using a commercially available eCTD builder. Monitor the progress of regulatory filings. Communicate with regulatory authorities, as needed, in support of these submissions. Maintain awareness of relevant guidance documents from regulatory authorities. Additional responsibilities may be assigned commensurate with the experience of the candidate. Perform other duties as required. Qualifications Bachelor’s degree required; advanced degree or equivalent experience preferred; concentration in life sciences, technical/engineering, or related field preferred. Minimum of 1 year of regulatory affairs experience required; 2 or more years of experience preferred. Experience in the development and submission of regulatory filings preferred. Strong communication and interpersonal skills. Precise attention to detail. Strong problem-solving and analytical skills. Ability to work with rapid changes: flexible and able to balance competing priorities. Ability to learn and apply pertinent regulations specific to functional work team. Self-motivated and capable of working in a diverse, fast-paced, and dynamic environment. Basic computer skills, including Microsoft Office Suite. Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities. Physical Demands The job will occasionally require standing for long periods, the ability to lift up to 25 pounds, and repetitive motions. Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
8 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Senior Director - Clinical Development Open Clinical Operations New York NY USA Reporting to the Head of R&D, the Senior Director of Clinical Development will have worldwide responsibility for the preparation and implementation of Abeona’s clinical development programs and pharmacovigilance. In partnership with the R&D Operations team, the candidate will also be responsible to ensure high quality of clinical deliverables and support flexible resourcing of programs. The individual who assumes this position will interact with multiple levels of management within Abeona and with external stakeholders in the medical and scientific community and global regulatory authorities. In close partnership with Company’s senior management and all R&D functions, the Senior Director of Clinical Development will be responsible for the short and long-term clinical development strategy of Abeona. Responsibilities Responsibility for advancing Phase 1-Phase 4 clinical programs from clinical study design and execution through interpretation of data and publication Provide medical and strategic leadership for programs that integrate current knowledge in basic and clinical science from within Abeona with that from the scientific community around the world Integrate the scientific rationale, regulatory requirements, product development plan, and commercial goals to build a solid strategic framework for the Clinical Development Plan (CDP). Research and deploy innovative approaches to clinical trials, including use of digital and electronic approaches In conjunction with clinical operations, establish efficient clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP. Contribute to the development of strategic initiatives and business development activities Develop and maintain relationships with program counterparts across Abeona Ensure rigorous adherence to Good Clinical Practice and ICH Guidelines Provide credible medical representation in the academic medical/scientific community Contribute to the development of clinical sections of regulatory documents like investigators’ brochures, briefing books, safety updates, IND/BLA submission documents, responses to questions from health authorities Represent Abeona externally and building key relationships with the medical community, investigators, key opinion leaders, contract research organizations, regulatory authorities, and clinical sites. Ensure that the scope of work, planning, expectations and project timelines are clearly communicated and aligned with clinical development team members and all key stakeholders Conduct staff performance reviews and development planning for the Clinical Development team and optimize clinical resources through recruitment and training of medical and scientific talent, as needed Drive goal setting for clinical development in alignment with corporate goals Preparation and monitoring of the clinical budget in conjunction with R&D Operations Requirements: MD degree required. Clinical experience in pediatrics, neurology, or internal medicine a plus. Ten (10) years of clinical development experience, including leading clinical development teams. Relevant experience of pharmaceutical development in rare diseases and clinical pharmacology preferred Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic and evolving environment. Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills. Ability to collaborate with a diverse workforce within a cross-functional matrix environment Strong communication (oral, written) skills to present internally and at scientific meetings and author medical documents and scientific publications Excellent working knowledge of FDA and EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies preferred Knowledge of medical monitoring of clinical trials required (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports) Demonstrated experience and expertise in the primary authorship of clinical trial protocols and clinical study reports Understanding of statistics and data management considerations for clinical trial design and scientific communications Experience in obtaining global regulatory approvals and/or expertise in translational/early clinical development for innovative medicines preferred Travel domestically and internationally as required Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
9 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 18th, 2019 12:00AM Senior Accountant Open Finance and Operations New York NY USA The Senior Accountant will work directly with the Controller to assists in all aspects of Abeona's accounting and finance activities. RESPONSIBILITIES: Assists with all accounting functions including but not limited to accounts receivable, accounts payable, general ledger, fixed assets, payroll, and purchasing. Establishes, modifies, and coordinates the implementation of accounting systems, policies, and procedures. Prepares, analyzes, and reconciles all financial statements and related reports including but not limited to balance sheets, income statements, cash-flow reports, budgets, and variance analysis. Provides specialized analyses in support of all business functions. Assists with the monthly balancing of books and monthly account reviews; prepares, analyzes and reconciles monthly financial statements. Assist with all budget process activities; forecasts all company operational and financial aspects.  Provides management with timely reviews of organization's financial status and progress. Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions. Assists with special projects as required. Indirectly supervises 1 employee within the finance department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.  QUALIFICATIONS:  Bachelor’s degree (B.A.) or equivalent. Four to six years related experience and/or training. Working knowledge of all aspects of accounting, forecasting and financial reports. Basic competence in duties and tasks of supervised employees. Ability to work with all levels of management. Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.   Commitment to excellence and high standards. Excellent written and verbal communication skills. Proficient in Excel, Word, PowerPoint, Outlook. Apr 17th, 2019 10:03PM Apr 17th, 2019 10:03PM
10 nasdaq:abeo abeona.applytojob.com abeona.applytojob.com Apr 8th, 2019 12:00AM Chief Medical Officer (CMO) Open New York NY USA Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the company’s close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases. Abeona is looking for a Chief Medical Officer to join the executive team.   Key Responsibilities: Responsible for the strategy, direction and execution of the company’s clinical development plans  Key member of the senior management team as a member of the company’s Executive Committee which determines and oversees research and drug development at Abeona and sets the overall strategic direction of the company  Managing and maintaining strong, effective relationships with our global vendors, consultants, investigators, and other external clinical trial participants to ensure that the primary goals of the clinical development programs are met  Responsible for representing the company with potential investors, regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of the company's product portfolio  Managing medical strategy, questions, and internal and external relationships that are related to our clinical programs  Monitoring/analyzing clinical trials for safety and, when appropriate, efficacy, and working in conjunction with external Drug Safety vendors to insure timely reporting of safety signals to regulatory authorities  Provide cross functional team leadership for clinical development, medical affairs, clinical operations, clinical pharmacology, etc…  Leading submission of essential documents to the TMF and Regulatory Department, as necessary;  Managing and coordinating deliverables, per vendor and CRO contracts, to ensure project deliverables are met on time and within budget  Reviewing and contributing the necessary templates and documentation (i.e., manuals, guides, communication plans) for each clinical study  Assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)  Communicating in a timely and effective manner with executive management and others, including the board of directors on clinical trial status and activities  Conduct investigator meetings and lead site initiation visits with clinical trial investigators  Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets  Translate findings from research and nonclinical studies into clinical development opportunities  Interact with clinical investigators, thought leaders, and patient advocacy groups  Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines Professional Experience/ Qualifications:  M.D. or M.D./Ph.D. Minimum of 10 years of biotechnology or pharmaceutical related experience in a clinical development leadership role  A mix of corporate and academic experience although the time spent in a corporate setting must be both significant and have been proven impactful Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment  Proven clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies in Rare Disease indications  Documented success in advancing therapeutic programs through clinical trials  Highly skilled in delivering programs and protocols that meet company specified targets and project objectives  Experience in the areas of Rare/Orphan Disease is required. Experience in Metabolism, CNS, Dermatology would be a plus.  Gene Therapy experience would be preferred  Experience working at a publicly traded biotech/pharmaceutical company  Must be a highly effective communicator who is able to establish collaborative internal/external working relationships, present ideas clearly and be perceived by others as approachable and accessible  Proven ability to think strategically and demonstrate expertise in developing and implementing policies and clinical development strategies and plans.  Self-starter who works with a sense of urgency and functions as a strong team player effectively working with and leading other disciplines  Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, investigators, and patient advocacy groups  Ability to communicate and work independently with scientific/technical personnel  Ability to think critically, and demonstrated troubleshooting and problem solving skills  The ideal candidate is a motivated self-starter passionate about working in a fast-paced small company environment  Patient focused, passionate about science an excited about having fun while working hard  Strategic leadership and tactical skills, excellent initiative and judgment, and demonstrated ability to positively represent the goals of Abeona Therapeutics Apr 7th, 2019 10:04PM Apr 7th, 2019 10:04PM

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