Chief Medical Officer
The primary role of the CMO will be to provide leadership and direction for the Company’s clinical development programs and pipeline of immuno-oncology approaches. The CMO will demonstrate ownership of and be a key contributor to the further development of the Company’s pipeline strategy. The CMO will be accountable for the direction and execution of the Company’s clinical development plans. The CMO will partner with the CEO and CFO as a member of the company’s Executive Committee and other line function leaders on the senior leadership team, to determine and oversee the research, drug development, and business strategy of the Company. This role offers a unique opportunity to be a major contributor to the success of a NASDAQ-listed clinical-stage biotechnology company.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES:
To perform this job effectively, the successful candidate is expected to demonstrate ownership and take accountability for tasks including but not limited to the following:
- Shaping the Company’s clinical development strategy and execution of clinical development plans to advance the Company’s early and late phase clinical portfolio by implementing cutting-edge practices of immuno-oncology
- Orchestrating and managing all clinical aspects of regulatory strategies and interactions with global Health Authorities for multiple clinical pipeline programs
- Overseeing the analysis and interpretation of clinical trial data and the reporting of clinical trial results
- Leading interactions with academic thought leaders, clinical investigators, and other stakeholders
- Providing clinical input while working closely with other members of the management team to develop and communicate the overall corporate strategy
- Representing the Company and its programs to external audiences, including investment, medical and regulatory communities, as well as academic, biotechnology, and pharmaceutical industry collaborators/partners
- Leading and supervising the clinical department, with direct line function responsibility for clinical operations, pharmacovigilance, patient advocacy, medical affairs, and translational medicine departments
- MD with Board Certification and robust experience in immuno-oncology (IO) drug development and translational sciences
- 15 years minimum experience in clinical practice treating patients as well as pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs
- At least eight years of management experience in large pharma and/or biotechnology setting as leader of a clinical department including clinical/medical affairs and clinical operations
- Proven track record in Phase I-III clinical studies and trial design including successful submission of INDs and marketing approval-directed filings (BLAs, NDAs, and MAAs)
EXPECTED KNOWLEDGE AND EXPERTISE:
- In-depth knowledge of relevant current FDA regulations and guidelines as well as those of the EU and other Health Authorities; experience in interactions with FDA personnel is essential; experience in interactions with other Health Authorities is a plus
- Detailed knowledge of clinical research concepts and practices including Good Clinical Practices (GCP) and International Council for Harmonization (ICH) guidelines
- Experience in late-stage drug development is required; working knowledge in translational medicine, clinical pharmacology, and early-stage development is highly desirable
- Experience with or strong knowledge of immuno-oncology drug development; knowledge of rare disease or gene therapy drug development is a plus
- Familiarity with the competitive landscape in the immuno-oncology marketplace and knowledge of immunology and/or oncology research and development space
- Excellent leader with executive presence, communication, and interpersonal skills
- Effective communicator who can convey credibility and confidence when articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the Company’s CEO, Board of Directors, employees, and the investor community
- Must be patient-oriented and data-driven with scientific rigor
- Must have the ability and strong desire to “make things happen” as a team player in a collaborative working environment internally and Company Executive externally
- The successful candidate will be able to read, write and speak fluent English
As a member of the senior leadership team, the CMO will actively participate in determining and implementing R&D and business strategies by incorporating innovation and providing consistent guidance to direct reports and direction to the organization. With exceptional leadership skills, the successful candidate will effectively mentor, motivate and empower others and, in particular, those with line function and management responsibilities. Interacts with the Company’s Board of Directors, Executive Committee, and senior-level management displaying analytical strength, critical thinking, expert negotiation, and bottom-line accountability for the organization. Willingness to make independent decisions while sharing the Company’s vision as a member of the Executive Committee to have a positive long-term effect on the Company’s success.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment. In an office setting, occasionally use hands to finger, and handle objects, tools, or controls. The employee must occasionally lift and/or move up to 20 pounds.
To apply, email your resume and cover letter to [email protected]. In the subject line of your email, please enter the exact name of the position for which you’re applying.