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Job ID: 7464
Job Title: Chief Medical Officer
Location: Washington DC-Baltimore, MD

Chief Medical Officer

Reports to: Chief Executive Officer

This is a key hire for our client , Inc. At its simplest level the CMO, reporting to the CEO, will be the company’s “Clinical Co-founder” providing hands-on clinical development leadership, KOL relationship building, clinical advocacy in support of the Company’s strategic and operational goals while keeping patient safety foremost Summary objectives for this role include:

1) Leading clinical development success including strategy, design, execution, regulatory submissions and approvals
2) Operating as the clinical thought leader for clinical programs
3) Educating and influencing key external parties on clinical scientific and medical affairs with investors, bankers, Key Opinion Leaders and regulators to support overall strategy
4) Serving as a member of the C-suite and Executive Leadership Team and directly, or indirectly via designees, on cross-functional teams and working groups
5) Advising CEO on clinical elements affecting strategy and capital including in-licensing and competitive assessment
6) Represent Our client’s technologies and products, on clinical development, clinical utility, and clinical scientific matters, including investors, bankers, Key Opinion Leaders and regulators to support overall strategy, clinical trials success, clinical adoption and commercialization

Our client utilizes a cross-functional team model organized around biologic programs. Ensuring effective clinical development and operations thought leadership, operational execution and coordination with program leadership and the cross functional team is a key element of success. Clinical operations and clinical trial execution will be a key supervisory role for the CMO.

Key Role Objectives:

1) Leading clinical development success including strategy, design, execution, regulatory submissions and approvals
a. Overall responsibility for successful clinical trial execution including patient safety and risk management, site management, patient enrollment and endpoint data capture
b. Crafting and executing trials plan for additional indications with view to maximizing value based on unmet need, Target Product Profiles alignment to need, and clinical standards of care
c. Strengthening and leading the internal and external clinical team, including advisory, CRO, regulatory consulting, trials SMEs/PIs, and Our client advisors
d. Developing strategy and leading engagement for efficient and effective clinical trial execution for all programs
e. Leading clinical portion of regulatory strategy development and execution including package development, submission and response for indication approval
2) Operating as the clinical leader for Our client’s programs
a. Supporting evaluation of the scientific and clinical viability of potential products, assessment of their commercial potential, and providing input during development.
b. Supporting our client indication strategy and prioritization based on core and in-development technologies.
c. Supporting cross functional teams, program/product leadership and regulatory leadership on clinical matters
d. Contributing clinical development, clinical operations and medical affairs insights and perspectives
3) Educating and influencing key external parties on clinical scientific and medical affairs with investors, bankers, Key Opinion Leaders and regulators to support overall strategy
a. Establishing and strengthening Our client’s position and relationships with clinician KOLs and select academic/scientific KOLs
b. Providing thought and medical affairs leadership for clinical/commercial adoption of our clinical indications
c. Supporting the CEO in interactions with investors and bankers on all clinical matters
4) Representing the company in scientific forums, conferences, industry associations and collaborating with investigators on scientific publications. Serving as a member of the C-suite and Executive Leadership Team and directly, or indirectly via designees, on cross-functional teams and working groups
5) Advising CEO as a senior executive leader and on clinical elements affecting strategy and capital including in-licensing and competitive assessment

CANDIDATE QUALIFICATIONS:

Personal Characteristics
• Hard working, driven to achieve, creative and practical clinician with high quality standards
• Entrepreneurial, hands-on leader with strong interpersonal skills
• Solid leadership skills, presence and strong interpersonal skills
• Collaborative team player
• Excellent oral and written communication skills
• Strong networking capabilities to attract talented teammates, collaborators, KOLs and consultants
• Comfortable representing the clinical aspects of the company as necessary at conferences and to investors

Qualifications and Experience:

• Education: MD or MD, PhD with a valid medical license.
• Demonstrated success leading regulatory approval, trials execution and transition to commercial/clinical adoption of at least one product with CBER
• Significant industry experience in clinical trial launch and execution in Phase 1 through 3, including pivotal & adaptive Phase 2/3 trial design and execution
• A proven record in clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s)
• Significant experience contributing to or leading written and oral communication with regulatory bodies including US FDA and CBER or EMA
• Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience. Knowledge of clinical trial management, data management, biostatistics, and drug development process.
• Medical specialty and sub-specialty training and certification relevant to Our client’s clinical focus such as, non-oncology Hematology, Trauma Surgery, Critical Care or transfusion medicine
• Experience in translational medicine and medical affairs a plus

Physical Demands:

• Expected Travel: 25 to 35%
• May operate remotely at an agreed upon schedule