Chief Operating Officer
The Chief Operating Officer (COO) is a key member of the Executive team, reporting to the CEO and will lead strategic, operational, and clinical activities of the group. The COO is responsible for formalizing the company’s strategic-planning processes and will drive the operationalization of the strategic plan with a human-centered focus and establishing greater transparency and accountability for those people carrying out the company’s strategy. In addition, the COO is responsible for assessing whether strategic initiatives, at all levels of the organization, are in line with the company’s objectives and mission.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned:
- Collaborate with CEO in setting and driving organizational vision, operational strategy, and hiring levels.
- Lead the development/creation of the strategic plan/framework for the organization, while adhering to direction set by the CEO and Board of Directors
- Translate strategy into actionable steps for growth, implementing organization-wide goal setting, performance management, and annual operations planning
- Serve as a culture builder, transformative leader and change agent; accountable for fostering healthy, diverse, and inclusive company culture
- Ensure effective recruiting, onboarding, professional development, performance management, and retention, building a highly inclusive culture that ensures team members can thrive and organizational outcomes are met
- Work closely with the CEO to assess new assets, opportunities and challenges; Engage directly with Board to ensure financial transparency and to communicate key financial goals and priorities.
- Overall support to CEO with portfolio and IP planning, fundraising, financial projects, investor and BOD relations.
- Drive contingency planning and risk management, ensuring organization can manage unexpected financial situations, market shifts and periods of both growth and contraction
- Generate and execute a clear drug development plan for each asset in portfolio, collaborating with expert consultants/KOLs in the fields of toxicology, PK, CMC development, clinical trial design and IP as needed
- Develop and implement plans to comply with policies related to corporate governance, federal and international regulations (as applicable), quality improvement, operational excellence, and appropriate training of personnel
- Ensure that operational plans are in place at various levels to achieve objectives
- Oversee the screening and selection of contract vendors for clinical trial execution; evaluate budgets and study plans to ensure all studies are conducted according to plans, timelines, budgets, and relevant guidelines
- Evaluate operational performance of projects ad teams using KPI metrics and budget reporting, working closely with finance
One or more direct reports
- Project Management
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Deep understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical operations; including understanding of clinical research principles, drug development process, FDA & ICH, GCP, GCDMP and related regulatory requirements & guidelines.
- Clinical experience in all phases of clinical development including IND filings and registration experience is a plus.
- Experience with rare disease trials and programs leading to accelerated approval is highly desired.
- Proven experience in CRO/vendor selection, contracting, oversight and relationship management.
- Demonstrated excellence in global clinical program/trial management including complex project management and effective management of multiple projects/priorities and budgets.
Education and / or Experience Required
- Bachelor’s degree in health sciences or related field; Masters or PhD preferred.
- Minimum 10 years’ experience in biotech or pharma environment; strong oncology therapeutic experience required.
Microsoft Word, Excel, PowerPoint and Project
While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds.
This is a remote position.
AAP/ EEO Statement
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.
Up to 25% domestic and/or international travel expected with routine travel to Chicago office.