Job Description 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 companys 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 companys clinical development plans ? Key member of the senior management team as a member of the companys 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 bc0F6GsCGE Associated topics: advertise, analyst, chief marketing officer, cmo, community, demand, facebook, government, medical center, solicitation
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.