About the Company
We are a well-funded, clinical-stage biopharmaceutical company focused on developing innovative small molecule therapies for cardiovascular and cerebrovascular pathology, including stroke, myocardial infarction, ischemic heart disease, and other ischemic conditions. Our pipeline is built upon groundbreaking research from one of the most prestigious academic institutions in the country and targets novel mechanisms to improve revascularization and address unmet medical needs in patients with compromised cardiovascular and cerebrovascular function.
About the Role
The Chief Medical Officer will lead the clinical development strategy for small molecule cardiovascular and cerebrovascular therapeutics, ensuring optimal delivery mechanisms and overseeing all regulatory affairs.
Responsibilities
Clinical Development Strategy:
Develop and implement comprehensive clinical development plans for small molecule cardiovascular and cerebrovascular therapeutics with focus on optimal delivery mechanisms.
Design Phase I-III clinical protocols targeting stroke, MI, ischemic heart disease, and related conditions.
Optimize formulation and delivery strategies for emergency/acute care settings.
Oversee clinical operations, data management, biostatistics, and clinical quality assurance.
Lead interactions with regulatory agencies globally.
Manage clinical trial site relationships and key opinion leader engagement in cardiology, neurology, and emergency medicine.
IND Management and Regulatory Affairs:
Oversee preparation and submission of IND applications for small molecule candidates.
Lead FDA and international regulatory communications and meetings.
Ensure compliance with all regulatory requirements and safety reporting obligations.
Manage regulatory strategy for expedited pathways and special designations.
Coordinate CMC and nonclinical activities supporting clinical development, including formulation development for rapid delivery.
Medical Affairs and Scientific Leadership:
Serve as primary medical and scientific spokesperson for the company.
Develop medical affairs strategy including publication planning and KOL engagement.
Oversee pharmacovigilance and drug safety activities.
Lead scientific advisory board interactions and external partnerships.
Support investor relations and corporate communications with medical expertise.
Team Leadership and Operations:
Build and manage clinical development, medical affairs, and regulatory teams.
Establish clinical operations infrastructure and vendor relationships, including acute care clinical trial networks.
Oversee clinical trial budgets and timelines.
Implement quality management systems appropriate for clinical-stage operations.
Foster collaboration across R&D, manufacturing, and business development functions.
Qualifications
M.D. or M.D./Ph.D. with clinical training in relevant specialty (Cardiology, Neurology, Emergency Medicine, Internal Medicine, or related field).
Board certification in relevant medical specialty.
Active medical license in good standing.
Required Skills
Minimum 10+ years of pharmaceutical/biotech experience with direct responsibility for small molecule drug development programs.
Proven track record leading small molecule compounds through Phase I-III clinical trials.
Deep understanding of small molecule pharmacokinetics, pharmacodynamics, and drug metabolism.
Experience with intravenous formulations and delivery systems for acute care settings (stroke, MI).
Knowledge of oral formulations for chronic cardiovascular conditions.
Familiarity with time-critical drug delivery requirements and rapid onset formulations.
Knowledge of chemistry, manufacturing, and controls (CMC) requirements for small molecules.
Demonstrated success with multiple IND submissions and FDA interactions.
Experience preparing and submitting IND applications, amendments, and annual reports.
Strong track record of successful regulatory meetings (Pre-IND, Type A, Type B, Type C meetings).
Knowledge of ICH guidelines, GCP, and FDA regulations (21 CFR Parts 312, 314).
Experience with international regulatory submissions (EMA, Health Canada, other agencies).
Familiarity with Fast Track, Breakthrough Therapy, and Orphan Drug designations.
Preferred Skills
Clinical development experience in stroke, myocardial infarction, or cardiovascular therapeutics.
Understanding of ischemic pathophysiology, reperfusion injury, and neuroprotection mechanisms.
Familiarity with cardiovascular and stroke biology, including acute coronary syndromes, cerebral ischemia, and tissue protection strategies.
Knowledge of current standards of care for stroke (acute ischemic stroke, thrombolysis, mechanical thrombectomy), MI (STEMI, NSTEMI), and related ischemic conditions.
Experience with cardiovascular and neurological endpoints and outcome measures (NIHSS, mRS, MACE, infarct size, ejection fraction, mortality).
Understanding of time-sensitive treatment windows and acute care delivery systems.
Experience with emergency/acute care drug development and hospital-based clinical trials.
CMO or senior medical leadership role at biotech/pharmaceutical companies.
Experience building and leading cross-functional clinical development teams.
Proven ability to develop and execute clinical development strategies.
Strong business acumen and experience supporting fundraising and business development activities.
Track record of successful drug approvals and commercial launches.
Pay range and compensation package
Competitive base salary commensurate with experience.
Performance-based annual bonus.
Significant equity participation.
Comprehensive benefits package.
Relocation assistance if applicable.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices and encourage applications from all qualified individuals.
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