Director, Clinical Development Sciences

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

📋 Description

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

• Direct the design, execution, analysis, and reporting of development programs, including protocol development.

• Manage program- and compound-level development initiatives and lead multidisciplinary clinical development teams.

• Engage in clinical strategy discussions and assist in the creation and review of clinical documents that support regulatory submissions.

• Represent Clinical Development Sciences within integrated development teams.

• Lead multidisciplinary clinical development teams, emphasizing proactive risk identification and management, consistency across programs, data integrity, and scientific validity.

• Own or scientifically assess the medical and scientific components of clinical research and regulatory documents, such as protocols, Investigator Brochures (IBs), IND, MAA or NDA modules, PIP/PPSR documents, and clinical study reports.

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

• Provide guidance and oversight on essential study-level documentation, including statistical analysis plans.

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

• Train Clinical Research Associates (CRAs) and contribute to laboratory assessments, including tables, listings, and figures.

• Serve as a subject matter expert for regulatory inquiries regarding global marketing applications and aid in addressing regulatory questions on Clinical Trial Applications (CTAs) outside the US.

• Establish and sustain communication and collaboration with peers in functional areas.

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

• Present to and engage with investigators and thought leaders.

• Conduct or oversee scientific training, including Site Initiation Visits (SIVs), Investigator Meetings, study data, clinical development, and medical advisory boards.

• Provide leadership and oversight to clinical development personnel and study-level scientists.

• Set objectives and assess staff performance; aid in career-path clarity, training initiatives, and leadership development.

• Execute other assigned responsibilities.

⛳️ Requirements

• A Bachelor’s degree is required.

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

• At least 10 years of experience in pharmaceutical development is necessary.

• A minimum of 3 years in a Sponsor role is required.

• Extensive experience in clinical development or a comparable combination of education and experience is essential.

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

• Experience in Rare Disease drug development is advantageous.

• A proven track record of scholarship, publications, and membership in scholarly societies, or a demonstrated history of successful protocol development, execution, and reporting in the industry is required.

• A solid understanding of the pharmaceutical business, global drug development, and regulatory processes is necessary.

• Capability to work independently and manage multiple studies simultaneously is essential.

• Strong leadership and interpersonal abilities are crucial.

• Proficiency in managing and nurturing relationships, making high-level recommendations/decisions, and communicating effectively at a senior management level and externally is needed.

• Ability to convey information clearly to target audiences, including presentations to the FDA and European Medicines Agency (EMA), investigator meetings, and external/key opinion leader (KOL) advisory panels is essential.

🏝️ Benefits

• Equal employment opportunities regardless of age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability, or other protected class characteristics.

• Commitment to adherence to all federal, state, and local laws.