Executive Director (Distinguished Scientist), Clinical Research, Atherosclerosis

Primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. Oversee the entire cycle of late-stage clinical development from Phase 2 to Phase V, including program strategy, protocol authoring, trial initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings.

Responsibilities

• Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
• Develop clinical development strategies incorporating scientific developments, regulatory requirements, competitive landscape, and commercial considerations.
• Plan clinical trials (design, operational plans, settings) based on clinical development strategies.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed medicines.
• Lead cross-functional product development teams overseeing overall strategy and execution.
• Analyze and summarize clinical findings to support safety and efficacy decisions, new drug applications, clinical study reports, or publications.
• Participate in internal and joint internal/external research project teams for new and marketed compounds.
• Support business development assessments of external opportunities.
• Manage other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projects.
• Work closely with Clinical Scientists, cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing.
• Assist in informing appropriate Corporate personnel about study progress, competitor drugs, and expert opinions on scientific questions.
• Maintain a strong scientific fund of knowledge through awareness of new findings, research methodologies, and prominent clinical investigators.
• Author and/or oversee development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitate collaborations with external researchers globally.
• Travel approximately 20% of the time to manage clinical research projects.

Requirements

• M.D. or M.D./Ph.D. required.
• Minimum of 3 years of clinical medicine experience.
• Minimum of 5 years of focused clinical development experience with demonstrated success in overseeing studies and protocols through completion.
• Experience in authoring regulatory documents and leading discussions with regulatory agencies.
• Demonstrated record of scientific scholarship and achievement.
• Proven track record in clinical medicine and background in biomedical research with a strong publication record.
• Outstanding interpersonal, collaborative, verbal, and written communication skills.
• Ability to function in a matrix environment.

Preferred Qualifications

• Board Certified or Eligible in Cardiology (adult or pediatric), Endocrinology, Nephrology, or related discipline.
• Minimum of 7 years of industry experience in drug development.
• Successful product registration experience.

Skills

• Required: Cardiovascular Diseases, Clinical Strategy, Clinical Trials, Cross-Functional Teamwork, Drug Development, Protocol Development, Regulatory Submissions, Scientific Leadership, Stakeholder Management.
• Preferred: Cardiology, Endocrinology, Nephrology.

Pay

The salary range for this role is $310,900.00 - $489,400.00. An employee’s position within the salary range will be based on factors including education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate, and sick days.

Schedule

• Travel requirements: 25%.
• Flexible work arrangements: Hybrid.