The Director of Clinical Development will support early to late-stage clinical studies across multiple indications and build and develop strong working relationships with Principal Investigators and study sites to optimize study conduct and position the Company as a true partner of choice in the clinical research landscape.

Responsibilities

• Act as the Sponsor’s Medical Monitor in close collaboration with clinical operations and CROs, responsible for conducting clinical studies in compliance with the protocol, interacting with study investigators and responding to protocol/medical questions related to participant eligibility, concomitant medications, safety issues and toxicity management
• Participate as a standing and/or ad hoc member in various clinical sub-teams (e.g., study execution team [SET], clinical study team [CST]) relevant to assigned molecule(s)/indication(s); support the CST lead with cross-functional integration, coordination, and alignment to enable effective and efficient clinical development plan execution
• Ensure that clinical study is conducted in compliance to GCP, company SOPs, governing laws, and regulations; review outstanding clinical or GCP issues, report and address issues across the study and, provide the study team with medical expertise during key activities
• Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Contribute to the design and development of clinical study protocols (Phases 1 to 3) from a concept sheet to a full protocol; participate in the review and finalization process with clinical operations, medical writing, regulatory affairs, clinical pharmacology, and other key cross-functional contributors
• In close collaboration with clinical operations, participate in the identification and selection of CROs, appropriate external investigators and sites
• Oversee and participate to protocol training, produce relevant training materials, and represent clinical development in Investigator meetings
• Coordinate with the study team to review and approve study processes and deliverables and participate in development of informed consent forms (ICF), case report forms (CRF), safety management plans, medical monitoring plans, statistical analysis plans (SAP) and clinical study reports (CSR)
• Lead the development of clinical responses to protocol questions by healthy authorities, independent review boards and ethical committees, in collaboration with regulatory affairs and/or clinical operations
• Collaborate with clinical teams to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such
• Review patient profiles, and study level data; review coding of adverse events (AEs), concomitant medications and protocol deviations
• In close collaboration with clinical operations, data management, biometrics and CRO, participate in all reviews and procedures required for database lock
• Review study data outputs to provide the most comprehensive clinical interpretation, for interim and final study reporting; develop topline study reports in collaboration with biometrics and relevant stakeholders (e.g., clinical pharmacology, translational sciences, etc.)
• Participate in the development and implementation of scientific communication and publication strategies for ongoing and completed studies
• Engage with principal investigators and key opinion leaders at advisory boards, major medical meetings, congresses, and other scientific events
• Collaborate cross-functionally in development of clinical sections of investigator brochures (IB), annual safety reports, IND and IMPD updates
• Review of clinical data generated by data listings or statistical analyses outputs for assigned studies and, present findings at quarterly drug safety reviews, as needed
• Support pharmacovigilance process; review individual data with Serious Adverse Events (SAEs) and important medical events; author and/or review all safety narratives and related regulatory reports (CIOMS, MedWatch)

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

• M.D. degree with at least 3-5 years of clinical research and development experience within pharmaceutical/biotech industry
• Clinical development experience in an industry setting ranging from Phases 1 to 4, including first-in-human and pivotal studies
• Experience with rare diseases, fibrotic diseases and/or lung is a plus
• Experience with development of clinical study related documents (e.g., clinical trial protocols, Investigator’s Brochures, clinical study reports)
• Knowledge of clinical trial methodology, statistics, regulatory and compliance requirements governing clinical trials, including GCP
• High integrity and the ability to bring out the best in others, intellectually and interpersonally
• Demonstrated strategic and critical thinking, dynamic leadership and team-building skills; as well as the ability to perform effectively in an adaptive environment
• Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills
• Able to facilitate collaborative discussions among groups with diverse technical expertise and varying opinions and drive decisions on complex issues