Clinical Development Director – Cardiovascular

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee medical and clinical development initiatives for assets within the General Medicine therapeutic domain.

• Responsible for clinical strategy, medical leadership at the study level, cross-functional decision-making, and supporting program execution from early clinical development through late-stage studies.

• Collaborate closely with Clinical Operations, Regulatory, Safety, Biostatistics, Medical Affairs, Data Management, and other functional teams.

• Provide clinical and medical leadership for one or more General Medicine programs or studies.

• Assist in the development, implementation, and communication of global clinical development strategies for cardiovascular assets at all development stages.

• Work with global teams to incorporate medical, scientific, regulatory, commercial, and market access insights into development programs.

• Establish and sustain strategic scientific relationships with key opinion leaders and external experts.

• Offer clinical and scientific leadership in the design, execution, analysis, and interpretation of clinical trials.

• Participate in authoring and reviewing clinical documents, safety evaluations, and risk-benefit assessments.

• Engage in regulatory interactions and support submissions to global health authorities.

• Analyze clinical trial results and contribute to data-driven development decisions.

• Present scientific and clinical data at various forums as assigned by the Global Development Leader.

• Recognize emerging scientific opportunities and unmet medical needs in cardiovascular medicine to guide future development strategies.

• Contribute to lifecycle management strategies and supply clinical content for regulatory submissions.

⛳️ Requirements

• MD or DO degree from an accredited medical institution AND 2 years of clinical development experience.

• Over 5 years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities in cardiovascular disease.

• Experience in clinical research within the biopharmaceutical sector (biotechnology, pharmaceutical, or CRO environments).

• In-depth knowledge of clinical trial design, execution, interpretation, biostatistics, adaptive trial methodologies, and evidence-generation strategies.

• Proven ability to collaborate across matrixed teams and influence without direct authority.

• Strong understanding of cardiovascular clinical endpoints, biomarkers, imaging techniques, and current treatment guidelines.

• Sound scientific and clinical judgment with the capability to assess complex benefit-risk profiles.

• Familiarity with Good Clinical Practice (GCP), FDA, EMA/CHMP regulations, ICH guidelines, and global regulatory requirements.

• Exceptional written and verbal communication skills, including the ability to convey complex scientific concepts to diverse audiences.

• Demonstrated success as a medical leader within a highly matrixed global organization.

• Strong strategic thinking, problem-solving, and decision-making skills with a proven track record of achieving results in complex development programs.

🏝️ Benefits

• A comprehensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work models where feasible.