Medical Director, Clinical Science

Role Summary

The Medical Director has a key scientific and analytical leadership role in the development of CLS core deliverables across study planning, design and execution, results analysis and regulatory filings. Key focus areas include acting as a study Medical Monitor and providing the scientific input into the creation and review of all CLS study deliverables and monitoring subject eligibility, study data and contributing critically to the scientific interpretation and integration of clinical study results. The Medical Director will also contribute to the scientific strategy and plan as outlined in the Clinical Development Plan (CDP). The Medical Director is also responsible for providing medical input into the creation and review of all CLS study deliverables to support clinical decision making, problem solving, and safety surveillance, as well as collaboration with external physician stakeholders.

Responsibilities

• Scientific Leadership
  • Support the definition of the core clinical and scientific strategy that serves as the basis for the CDP and provide CLS expertise in the design and execution of clinical studies under the purview of the CDP
  • Participate (as assigned) in the development of CLS-assigned sections of regulatory filings and in drafting regulatory responses in collaboration with Medical Writing
  • Establish relationships with investigators and KOLs as appropriate in support of the CDP
  • Stay up to date with advances in literature in therapeutic/disease area including mechanism of action, diagnostic tests, treatment, drug development trends, and regulatory requirements
  • Develop therapy-specific publication plans and work with internal and external colleagues to prepare study results for timely publication
  • Attend and contribute to relevant scientific conferences, seminars or presentations
• Clinical Study Planning and Monitoring
  • Act as the scientific subject matter expert, and primary contact, for assigned clinical study; take a proactive approach to identifying issues and mitigating risk
  • Initiate and provide the medical and scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions and other key study deliverables
  • Provide clinical input to statistical analysis plan to ensure alignment with Regulatory and business interests
  • Facilitate the review and approval of all study related CLS deliverables and content
  • Act as study scientific subject matter expert and main point of contact for Principal Investigators (PIs) and sites to assess subject eligibility, provide scientific rational and manage ongoing protocol issues
  • Provide leadership to sites by developing or participating in training, answering investigator/site questions about the protocol
  • Respond to site and Health Authority questions about the protocol
  • Conduct periodic review of protocol deviations in collaboration with Clinical Operations Study Lead or designee
  • Attend and present at Investigator Meetings, as needed
  • Conduct data review, assessment and interpretation of clinical data to ensure that the data are correct and presented with the appropriate interpretation including thorough review of SAEs and other important AEs
  • Review and analyze SAEs, safety and efficacy trends on an ongoing basis
  • Work closely with the Pharmacovigilance representatives providing medical input into safety reports including, SAE narratives and analysis of similar events, DSURs and SUSARs, and related safety documents
  • Participate in and provide scientific advice during key Database Lock activities and data snapshots
  • Collaborate with Biometrics to identify key issues, prepare content and facilitate discussions at study Data Review Board or Data Monitoring Committee
  • Lead the selection of and interactions with independent Data Monitoring Committees (DMC)
  • Act as the medical subject matter expert for review of clinical and safety data to ensure data are correct and presented with proper interpretation and discuss safety concerns with sites
• Governance and Communication
  • Provide timely and high-quality functional deliverables and contributions to Study Execution Team (SET)
  • Act as primary point of contact between SET and CLS to ensure appropriate dissemination of information and communication
  • Provide agenda topics to be discussed during SET meetings
  • Act as the medical and scientific subject matter expert (SME) to the SET with the ability to make decisions and recommendations on behalf of CLS
  • Proactively identify and communicate potential risks and mitigations relevant to the CLS deliverables
  • Contribute to the development and maintenance of study-specific plans
  • Collaborate with CLS Therapeutic Area Lead, CDTL and CSL on all study related decisions
  • Escalate issues affecting CLS deliverable quality, timelines, resources or budget
• Competencies
  • Identify scientific and medical knowledge gaps to drive research and publication strategies
  • Assess the clinical and medical impact of research findings on therapeutic area and development strategies
  • Conduct comprehensive document evaluations including evaluation of statistical presentations, methods, and content quality
  • Identify best practices and innovative approaches for strategy development
  • Demonstrate ability to look beyond the obvious toward innovative approaches

Education

• MD, MD/PhD (or equivalent)
• Advanced degree in life or health sciences (e.g. PhD/PharmD/RN)

Qualifications

• 5 or more years of relevant experience in Clinical Development, with experience in genetic diseases, specialty care, and/or rare diseases desired; clinical experience preferred