The Chief Operating Officer at Regencor will lead the operations of the company’s business, manage internal functions, and support the growth of the company’s products and business. On a day-to-day basis, the COO will be responsible for building, managing, and integrating all of the company’s operating functions.
Responsibilities for the COO include:
In collaboration with the CEO, lead the clinical commercialization and brand building activity for the company.
Working with the Senior Executive Team, coordinate activities to move towards company objectives.
Maintain overall awareness and leadership of company’s internal operations.
Working with the CEO, prepare and manage the company’s budgets.
Manage company-wide performance management processes.
Manage product development, facilities, HR and other company functions.
Regencor is seeking a key business leader to help drive the next phases of the company’s growth. The CBO will partner with the Chief Executive Officer and other senior team members, with respect to fundraising, product development strategy, potential commercialization partnerships with respect to the Company’s pipeline programs, clinical collaborations/partnerships involving the development and testing of the company’s lead clinical assets, strategic portfolio planning and pipeline prioritization and assessment.
The newly created position of Chief Business Officer at Regencor will be responsible for:
Lead business development: strategy, outreach and execution.
Develop a strategic plan and obtain management/board of directors’ alignment for a business development partnering strategy for clinical programs and pipeline programs. Execute on that strategy as planned/approved
Build relationships with biotech and pharma partners for clinical collaboration studies. Execute on that strategy as planned/approved.
Near term and long-range partnering planning
Partner with senior management to integrate scientific/clinical/commercial aspects of the Company on publications and presentations in support of driving outside interest in partnerships, clinical collaborations and fund raising.
Commercial strategy and planning
Work with the team on assessment of global partnering opportunities
Work with the CEO on financing, investor presentations and meetings
Present business development strategy and execution to the board of directors
Reporting to the Chief Scientific Officer, the Head of Preclinical Development will be responsible for the research and development oversight of Regencor’s therapeutics programs. He/She will be accountable for leading pre-clinical development of multiple programs towards IND submissions. The Head of Preclinical Development will be passionate about novel therapeutics and applications for cardiac regeneration and managing an external group of CROs and CMOs to drive execution of multiple pre-clinical programs.
Responsibilities and accountabilities for this role include:
Manage an external group of CROs and CMOs to ensure project(s) progress and adherence to budgets for the preclinical development of the Company’s novel therapies.
Provide scientific and managerial leadership, vision, execution and communication of both strategic and tactical objectives for the product development pipeline.
Drive to develop compelling data sets and materials to support product development.
Work with the Head, Clinical/Regulatory on engagements with the FDA and other regulatory agencies to help inform and progress development programs.
Align R & D activities to optimize the company’s intellectual property estate.
Provide leadership direction within the research group through objective setting, performance management, and individual development.
Work collaboratively with all internal and external scientific and management colleagues.
The Head of Clinical/Regulatory Affairs will be responsible for the strategic planning and execution of clinical development programs in the company’s pipeline. As the Head of Regulatory, candidates will also provide management oversight and strategic direction for regulatory and quality activities for Regencor, including regulatory strategy, filings and approvals, quality compliance, product quality assurance and process improvement, and also document control systems.
The Head Clinical/Regulatory will be a key member of the senior management team which will be responsible for setting the strategic direction of the company. This position will report to the Chief Executive Officer.
Responsibilities will include:
Direct the design of clinical strategies and development plans across programs in the company’s pipeline of regenerative products.
Execute company clinical and regulatory strategies/plans, develop contingency plans when necessary, provide technical and strategic advice on an ongoing basis, and meet company milestones and budgets.
Orchestrate and manage the medical and scientific aspects of regulatory strategies and interactions with both US and ex-US health authorities.
Oversee the design, analysis and interpretation of clinical trial data and the reporting of clinical trial results.
Lead the interactions with academic thought leaders, study investigators, patient advocacy groups, and key clinical stakeholders.
Oversight of publication in the development of a scientific communication and project plan for Regencor’s products.
Representing the clinical organization within the Business Development Teams.
Participation at numerous national and regional conferences, meetings and other scientific venues.
Serve as the strategic and technical expert for all regulations (FDA, EMEA, CE, ISO, etc.) ensuring the proper processes, policies, and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
Manage relationships with the relevant regulatory agencies to improve the quality of submissions and understand the impact of pending or proposed regulatory changes.
Monitor external regulatory developments, identify risks and communicate potential issues to the Regencor team.
Take responsibility for all Regencor regulatory submissions to ensure that they are accurate and submitted in a timely manner.