Clinical Development Director – Early Development, Inflammation/Rare Disease

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

📋 Description

• Oversee the initial phase clinical development of compounds, starting from first-in-human studies to proof-of-concept.

• Collaborate with teams to assist in the design and execution of early phase clinical trials.

• Aid in the development of protocols and IND submissions, along with study initiation, data analysis, monitoring, and evaluation activities.

• Play a role in crafting and executing the early clinical development strategy for therapeutic candidates in Inflammation, General Medicine, or Rare Disease.

• Help in the formulation of clinical development plans, clinical study protocols, informed consent documents, Investigator Brochures, and submissions to Ethics Committees and regulatory agencies.

• Assess and analyze clinical study data regarding safety, efficacy, pharmacodynamics, and pharmacokinetics.

• Contribute to the strategic use of clinical biomarkers to enhance drug development.

• Work in conjunction with colleagues from Precision Medicine, Research, Clinical Pharmacology, Operations, Late Development, Regulatory, Safety, and Commercial sectors.

• Assist in evaluating external licensing or partnership prospects within the cardiometabolic/general medicine therapeutic domains.

• Partner with external experts to deliver biomedical expertise and strategic insights to Early Development teams.

⛳️ Requirements

• MD or DO degree from an accredited medical institution.

• A minimum of 2 years of experience in industry or academic/basic sciences/clinical development.

• Board certification or eligibility in Internal Medicine or a relevant subspecialty (preferred).

• Completion of residency training in Internal Medicine and a relevant subspecialty (preferred).

• Familiarity with the pathophysiology of inflammatory, general medicine, and/or rare diseases (preferred).

• Experience in basic research and/or clinical trial methodologies (preferred).

• At least 3 years of relevant drug development experience in the pharmaceutical sector and/or academia, particularly in early stage clinical trials (preferred).

• Proven experience working with pharmaceutical sponsors (preferred).

• Skilled in designing, monitoring, and executing clinical trials, along with interpreting trial outcomes (preferred).

• Demonstrated leadership capabilities; able to conduct studies collaboratively within a team (preferred).

• Experience in a matrix environment, contributing to decision-making and achieving consensus to meet demanding deadlines (preferred).

• A track record of publications (preferred).

• Strong interpersonal and presentation skills; proficient in effective communication with both internal stakeholders and external partners/collaborators (preferred).

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

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

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentive plans.

• Award-winning vacation policies.

• Flexible work models where applicable.

• Opportunities for career advancement.

• Financial plans designed to help employees save for retirement or other objectives.

• Emphasis on work/life balance.