Associate Director, Clinical Development
Duties and Responsibilities:
• Responsible for the relevance and accuracy of clinical science planning and guidance for a clinical program (e.g. study concepts/synopsis, eligibility, database elements, protocol and product-related training, investigative site questions, literature benchmarks) to clinical study teams
• Works closely with Medical Director, Chief Medical Officer, Head of Clinical Development and Investigators to accumulate scientific and clinical knowledge necessary to support clinical development execution of study concepts/synopsis, clinical protocols/amendments, and data collection.
• Leads the development of key study related documents and deliverables including but not limited to study synopsis, protocols/amendments, study manuals (e.g. pathology manual)
• Review and support clinical program and study related documents such as Investigator’s Brochures, Clinical Study Reports, Annual Reports, Statistical Analysis Plans
• Works with investigative sites and/or study teams to answer protocol related questions, resolve study conduct and design issues
• Present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
• Evaluates literature reviews and regulatory guidance and precedence to inform on clinical development programs and regulatory strategy
• Drives, integrates and/or authors Clinical sections of regulatory correspondence and submissions including but not limited to Information Requests, Meeting Information Packages and presentation materials, and IND/NDAs
• Key contributor in regulatory health authority interactions
• Lead the clinical project team in the assessment of emerging clinical data and safety data trends, including support of data management, clinical monitoring, interim analyses planning and Data Safety Monitoring Board or Steering Committee meetings
• Review case report forms, clinical data listings, patient profiles and summaries to ensure data collection proceeds in a manner consistent with the protocol and clinical development strategy
• Support clinical and safety database reconciliation as applicable
• Reports to leadership on clinical trial findings and milestones
• Develop and maintain relationships with key internal and external stakeholders (i.e., Medical Affairs, Commercial, Key Opinion Leaders, vendors, committees) in support of clinical strategy, development programs, and other deliverables including publications/abstracts and presentations
• Support Medical Information request and Medical Affairs ad hoc requests; review of abstracts/publications and presentations
• Attends scientific meetings to remain abreast of clinical developments, interact with investigators, and advisors
Education: MS, PhD, MD, or PharmD required.
• Has a minimum of 8 years of experience in pharmaceutical industry with at least 5 in a Clinical Scientist/Clinical Development role, or significant relevant experience in clinical trials. Oncology experience preferred.
• Has authored industry documents and/or has published in medical/scientific peer-reviewed journals.
• Understanding of GCP/ICH
• Demonstrated experience reviewing clinical data and statistical outputs
• Ability to conduct basic data reviews and analyses using Excel and other tools
• Must possess highly effective analytical, communication (verbal and written), and presentation skills
• Demonstrated problem solving and sound decision-making skills
• Diplomacy and leadership of cross-functional teams related to clinical content training
• Experience building clinical data presentations
• Must be able to work productively in an extremely fast-paced collaborative environment;
• Adaptable to multiple demands, shifting priorities, and be agile to operate at-risk based on available supported information