Associate Director / Director, Clinical Science & Development

Job Summary: The Associate Director / Director of Clinical Science & Development will be a key member of project, research, and clinical development teams. The role will play a critical role in driving clinical development results for our oncology, immune impairment, infectious diseases and cell therapy programs in development.

This position requires a general understanding of key therapeutic areas, excellent communication, collaboration and leadership skills, and an awareness of business principles. This role requires working in a matrixed team environment with Research, CMC, Clinical, Quality, Regulatory, and Program Management functions.

This posting represents a single opening in which either an Associate Director or Director level candidate will be selected based on experience and qualifications, as stated in the Qualification section below.

Key Responsibilities

• Support Program Lead and Medical Monitor with program strategy and execution, and target product profile in line with the early development program, commercial strategy and regulatory needs
• In collaboration with Program Lead, prepare presentations to obtain endorsement of the clinical strategic plan with the appropriate governance committees
• Support liaison with different functions with expertise and leadership (data management, biostatistics, medical writing, pharmacovigilance, regulatory, clinical operations, translational medicine) as well as interact with and support Program team members and project management
• Support the preparation of key clinical documents to be prepared for clinical trials (protocols, amendments, benefit risk assessments), interactions with internal governance bodies, external partners, key opinion leaders, investigators
• Build and maintain a strong network of external vendors
• Support authoring briefing packages for submission to health authorities, and work in collaboration with regulatory product manager to devise strategy for path to regulatory approval and interactions with health authorities
• Maintain deep scientific, technical, and clinical expertise in immuno-oncology drug development
• Partner with internal competitive intelligence SME to evaluate relevant literature, data and the status from competitive products; provide clinical landscape and benchmark updates to Program Lead
• Support clinical reviews of data listings, patient profiles, and essential study data within statistical reports and partner with Medical Monitoring and Data Management/Operations in generating relevant queries
• Support and/or generate in-house tables/listing and figures to facilitate internal discussions
  
  

Qualifications

Associate Director:

• Advanced degree (MS, RN, or MBA; PhD scientist and Biomedical Science master is a plus)
• 7-10 years of relevant professional experience, including 5 years of industry experience required; industry experience should include both research and clinical development
• Salary-$180K-$210K
  
  

Director

• Advanced degree (MS, RN, or MBA; PhD scientist and Biomedical Science master is a plus)
• 10-12 years of relevant professional experience, including 5 years of industry experience required; industry experience should include both research and clinical development
• Salary-$210K-$250K
  
  

Both

• Proficient in clinical literatures and critical interpretation of clinical study results
• Experience with supporting preparation and execution of clinical trials
• Experience with health authority interactions is a plus
• Strong scientific and academic background in oncology, including translational science and tumor biology
• Strategic thinking in combination with understanding of up-to-date science and technologies to support to clinical development
• Experience with basic principles of data analysis, interpretation and clinical relevance
• Experience in successful collaboration with and leading cross-functional activities with interdisciplinary professionals
• Ability to interact and effectively communicate with all levels of personnel within the organization and with clients of the Sponsor company (i.e., vendors and CROs)
• Strong leadership, interpersonal, communication, and presentation skills
• Outstanding communicator, excellent problem-solving, conflict-resolution and decision-making skills
• Driven individual and performance oriented with ability to work along agreed timelines
• Proven ability to manage projects/team of significant scope and complexity, while meeting all deliverables and timelines