Description
The VP, Clinical Development will be responsible for leading the strategic and tactical planning, development and execution of all clinical trials. This individual will work collaboratively to gain a deep understanding of the priorities of each department supporting clinical trials (Translational Medicine, Nonclinical Safety, Clinical Operations, Biometrics, Regulatory, CMC) and integrating these priorities into the clinical trial design to ensure that all study objectives are achieved in a strategic, efficient, and cost-effective manner.
Essential Duties & Responsibilities
Clinical Trial Leadership
- Serve as clinical development lead, including leading the development of program strategy at the Core Team level.
- Drive the design, development and vetting with KOLs the clinical trial protocols, ensuring they meet scientific, medical, and regulatory requirements.
- Design and author/co-author clinical trial protocols and all related documents (eg laboratory manuals, ICFs, pharmacy manuals, SAPs, etc) for clinical studies.
- Monitor, review and summarize safety (including timely reporting to regulatory authorities) and efficacy data, including biomarker data, in ongoing studies.
- Support the execution of clinical trials, ensuring adherence to the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Participate in the preparing and review of documents for regulatory submissions (IND, BLA, etc.), including clinical study reports, Investigator’s Brochures, and responses to regulatory agency inquiries.
- Collaborate with biometrics and data management team to ensure accurate data collection, analysis, and reporting. Review and interpret clinical data to make informed decisions about study progression.
- Define opportunities for innovation and improvement in clinical trial methodologies and therapeutic approaches, including collaborating with Translational Medicine to consider and implement novel biomarker-based endpoints.
Internal Collaboration
- In collaboration with the Clinical Immunology Team (Translational Medicine, NCD & Clinical Pharmacology), ensure that the Translational Medicine Biomarker Plan (including at risk biomarkers, POM biomarkers, intermediate outcomes biomarkers) are effectively incorporated (eg schedule of assessments) and implemented in the clinical study protocol in a manner that will achieve the intended goals (eg safety monitoring, POM, surrogate endpoint, etc).
- Align with Clinical Operations to provide study budget, timelines, and associated metrics to Program Management for integration onto cross-functional corporate timelines and milestones.
- Provide strategic leadership and support to clinical operations, biostatistics, regulatory affairs, and other departments to ensure seamless trial execution; identify issues and recommend solutions for immediate action.
Internal & External Presence
- Participates in regular cross-functional scientific meetings (currently the weekly Clinical Immunology meetings) to ensure alignment on study priorities, review of data (eg safety, PK/PD, RO, POM) as available from various functional areas to make collaborative decisions that impact study execution.
- Form and lead clinical advisory meetings, including developing relationships with consultants, key opinion leaders (KOLs) and external experts to obtain feedback on protocol design and compound strategy.
- Provide integrated clinical trial updates (eg study design, safety, PK/PD, RO, POM, efficacy) representing the overall study results to internal and external stakeholders.
- Author and present abstracts at disease specific congresses and serve as lead to draft manuscripts with medical writing support.
Requirements
KNOWLEDGE, SKILLS, AND ABILITIES:
- Expertise in human immunology, with experience in leading clinical trials for compounds that impact the immune system.
- Experienced in participating in the design, execution and analysis of Phase 1 clinical trials.
- Excellent analytical, quantitative, problem-solving skills and ability to manage multiple projects and initiatives simultaneously in a fast-paced, dynamic environment.
- Demonstrated experience in working with cross-functional teams in the development and execution of clinical trials.
- Outstanding interpersonal and communication skills (written and oral) and ability to communicate complex information succinctly, with the ability to generate clinical reports and presentations.
- Experience authoring global regulatory submissions (eg new drug applications, briefing books) and interaction with global health authorities. Experience drafting and executing Phase 1 and initial patient (EPOC/ POC) trials.
- Highly self-motivated to achieve results, influence, drive collaboration, and resolve conflicts across internal and external project teams.
Education And Experience
- MD with a minimum of 15 years’ scientific and/or clinical experience in immunology, molecular biology, health care delivery
- 5+ years’ experience in leadership and management of a team
Physical Requirements/Work Environment
This position primarily works in an office environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. This position requires work before or after normal working hours (8am – 5pm) during the work week and on weekends.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
