Director, Clinical Development Sciences

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Direct the delivery of high-quality data from various sources while facilitating global development programs for one or more product candidates through all phases of study.

• Oversee the design of development programs, conduct, management, protocol design, execution, analysis, and reporting.

• Lead development activities at the program and compound level, along with multidisciplinary clinical development teams.

• Participate in clinical strategy discussions and create and review clinical documents that support regulatory submissions.

• Represent Clinical Development Sciences in integrated development teams to maintain scientific, ethical, and regulatory standards, aiding in worldwide registration submissions.

• Guide multidisciplinary clinical development teams, focusing on proactive risk identification and management, consistency, data quality, and scientific integrity.

• Evaluate medical and scientific components of protocols, IBs, IND, MAA/NDA modules, PIP/PPSR documents, and clinical study reports.

• Act as a subject matter expert for designated clinical development programs, leading trial/program design, data collection tools, data review, and data analysis.

• Provide input and oversight for essential study documentation, including statistical analysis plans.

• Facilitate optimal study execution and data collection in collaboration with clinical operations, data management, and statistics.

• Train CRAs, choose laboratory assessments for safety and pharmacodynamics, and contribute to tables, listings, and figures.

• Serve as a subject matter expert for global marketing-application regulatory inquiries and assist in addressing CTA questions outside the US.

• Collaborate with study teams, data management, biostatistics, regulatory affairs, and other functional colleagues.

• Support the external dissemination of clinical trial data through publication committees, abstracts, posters, and manuscripts.

• Engage with and present to investigators and thought leaders; conduct or oversee scientific training, investigator meetings, study-data sessions, and advisory boards.

• Provide leadership and supervision to clinical development staff and study-level scientists.

• Establish goals and assess performance for direct reports; facilitate career-path clarity, training plans, and leadership development.

• Execute other duties as assigned.

⛳️ Requirements

• Bachelor’s degree is required.

• A minimum of 10 years in pharmaceutical development, including at least 3 years in a Sponsor role and extensive experience in clinical development, or a comparable combination of education and experience.

• Proficiency in clinical trial and program design, execution, interpretation of scientific data, GCP, statistical analysis, and management of cross-functional clinical/regulatory teams.

• Experience in Rare Disease drug development is preferred.

• Proven history of scholarship, publication, and membership in scholarly societies OR a demonstrated record of successful protocol development, execution, and reporting in the industry.

• Knowledge of the pharmaceutical business, global drug development, and regulatory processes.

• Capability to work independently and manage multiple studies at the same time.

• Excellent leadership and interpersonal skills; adept at managing and fostering relationships, making high-level decisions, and effectively communicating with senior management and externally.

• Ability to convey information appropriately to different audiences, including patients, regulatory agencies, FDA, EMA, investigators, and external/key opinion leader advisory panels.

• Advanced scientific degree (MD/PhD/PharmD) is highly preferred.

🏝️ Benefits

• Commitment to equal employment opportunity.

• Employment protections for veterans and individuals with disabilities.

• Compliance with federal, state, and local employment laws.