Associate Director, Clinical Development Scientist

Introduction to Role

The Associate Director, Clinical Development Scientist (CDS) may lead a cross functional team in the design and execution of a clinical study and may provide input into the global clinical development plans and strategy for a therapeutic area. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical development plan design and execution and therapeutic area strategy.

Accountabilities

• Lead a team in preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents (may manage several studies in parallel).
• Lead a study team to design a clinical protocol, including engaging with relevant internal and external partners; responsible for preparing materials and protocol defense presentation for C-PRC review.
• Represent the clinical study team at the clinical sub team.
• May supervise and develop clinical development scientists and/or fellows.
• Participate in Investigator meeting planning and execution and/or on-site initiation meetings.
• Lead the execution of clinical trials; Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
• Lead a team in study execution, including country and site selection, site training and start-up and data monitoring; expertise in data analysis and presentation required.
• Depending upon specific expertise in translational science, may lead a translational sub team of the clinical team.
• Liaise with other functions to build external expert consultations, contribute to the development of study concepts and designs, protocols and study essential documents.
• Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy.
• Engage with investigators, site staff, CROs, and site monitors to maintain passion and support enrollment for ongoing clinical studies.
• Where appropriate, serve as the SME for identification, translation, inclusion, implementation and reporting related to liquid, tissutal and/or imaging endpoints.
• Lead the execution of clinical trials and associated data collection activities, providing guidance to the clinical study team related to: country and site feasibility assessments and selection, site training and oversight, patient recruitment, ongoing data monitoring, study closeout.
• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy.
• Help to determine appropriate advisory boards experts.
• Provide support for business development activities, such as due diligence and research collaborations.
• May serve as the Translational Science lead for one or more programs.

Essential Skills/Experience

• Bachelor's Degree
• 5+ years of industry experience in clinical development is preferred
• Understanding of general (and specific) therapeutic principles
• Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
• Familiar with scientific literature searches and weighing of quality peer reviewed data
• Ability to clearly communicate to internal and external partners orally and in writing
• For those assigned to clinical endpoint support, e.g., imaging, experience in at least one meaningful modality, e.g., ultrasound, computerized tomography, magnetic resonance, positron emission tomography
• Specific therapeutic area experience
• Basics of strategic vs. tactical thinking
• Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• Strong intuition for business; including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results

Desirable Skills/Experience

• Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree) required
• Advanced knowledge of the assigned therapy area is desired