Study Responsible Physician- Neuroscience (Pediatric Studies)

Benefits

Qualifications

• •MD (or equivalent) in relevant area; MD/PhD
• •Minimum of 1 year of experience conducting clinical trials in pharmaceutical, biotechnology, or CRO settings, with direct involvement in pediatric populations; OR
• •Minimum of 2 years of experience conducting clinical trials in an academic setting, with some focus on pediatric or adolescent patient populations
• •Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
• •Solid analytical and critical thinking skills, with the ability to interpret and leverage data for decision making
• •Strong communication and presentation skills to effectively convey complex ideas and strategic insights to stakeholders
• •Independent decision making and analytical skills are required
• •Ability to navigate complex relationships and resolve conflicts effectively
• •Exceptional interpersonal and communication skills, with the ability to build strong relationships and influence without reporting authority
• •Excellent problem-solving and conflict resolution skills, with the ability to navigate complex and challenging situations
• •Proven experience and expertise in leading and managing in a matrix organizational structure
• •Exceptional problem-solving skills with the capacity to anticipate risks, to develop creative solutions and to meet objectives
• •Demonstrated ability to develop deep insights (e.g., big picture thinking) based on data analysis and interpretation
• •Results oriented, able to think creatively, critically, and proactively, to drive innovative solutions
• •Working knowledge of the use of Microsoft suite of software products including Excel and Word
• •Fluent in written and spoken English
• •13 more items(s)

Responsibilities

• •The Neuroscience Therapeutic Area (TA) Study Responsible Physician (SRP) is accountable for the medical leadership, design, and execution of pediatric clinical studies within the Neuroscience TA clinical portfolio
• •The SRP is a core member of the cross functional study team, working in close partnership with the Clinical Lead and providing expert pediatric medical and scientific leadership across all phases of study delivery
• •The SRP contributes substantively to the clinical development plan, with a particular focus on pediatric strategy, and leads or supports the development of pediatrics focused clinical trial protocols, associated trial materials, investigator training content, clinical study reports, and key documents supporting regulatory submissions
• •A central responsibility of the SRP is the medical oversight of patient safety, including ongoing, in depth review of clinical data, adverse events, medical histories, and protocol deviations
• •The SRP engages in frequent site interactions to ensure protocol compliance, high quality data, and the protection of pediatric trial participants, while providing medical guidance to address emerging safety or feasibility issues
• •The SRP operates within a highly matrixed environment, collaborating closely with project management, regulatory affairs, clinical operations, data management, biostatistics, medical writing, global safety, quality and compliance, clinical supplies, legal, finance, global medical affairs, and other scientific and business partners
• •As needed, the SRP may also contribute to the evaluation of scientific and clinical development opportunities within the Neuroscience TA
• •Responsible for medical monitoring/reporting and company safety officer activities
• •Works on clinical development plans, trial protocols and takes ownership of clinical study reports
• •Evaluates adverse events (pre- and post-marketing) for relationship to treatment
• •Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting related to study conduct or outcome
• •May act as a medical contact at the company for health authorities concerning clinical/medical issues
• •Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
• •Close interactions with Project Clinical Scientists and Physicians across programs
• •Assists Regulatory Affairs in the Pediatric development regulatory strategy
• •Executes medical-related consultation for internal stakeholders to ensure unbiased data interpretation
• •May help explore and evaluate new assets (BD) and/or products to support compound value, including review of medical literature related new technologies
• •Participates in AdBoards & KOL interactions where required (together with / under supervisor of senior clinical personnel)
• •Participates in the development of presentations and publications of study results
• •16 more items(s)