142 days ago on sjobs.brassring.com

Medical Director - Ophthalmology

Novartis Pharma Schweiz AG

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Medical Director - Ophthalmology

Job ID 197791BR Position Title Medical Director - Ophthalmology Division PHARMA Business Unit Global Develop NPH Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Therapeutic/Disease Area Ophthalmics/Ophthalmology Job Type Full Time Employment Type Regular Job Description The Medical Director (MD) is responsible for the global scientific and medical strategy of assigned sections of a complex clinical development program (e.g., an indication, new formulation, or specific development phase) and may lead indications or programs, depending on the size, nature and complexity. The MD is responsible for design and execution of a Clincial Development Plan (CDP) and medical monitoring and reporting of one or more clnical trials to support decision milestones, regulatory approval/market access, and budget targets for assigned section or sections. The MD may lead the Global Clinical Team (GCT), work closely Clincal Trial Teams (CTTs), represent Clinical Development at the Global Program Team (GPT), and together with Drug Safety and Epidemiology (DS&E) owns the risk benefit assessment of the indications or programs.

Provides clinical leadership and medical and scientific strategic input for clinical deliverables in the assigned section of a clinical program or programs. This includes contribution to clinical trial design and responsibility for medical/scientific components of assigned CTP(s) ensuring alignment with the CDP, available disease and program level clinical standards, and the Target Product Profile (TPP)
 For assigned section or program, provides expert medical and scientific input and contributes to writing trial related documents (e.g., CTPs, case report forms, data monitoring committees, data analysis plans, reports, publications) consistent with CDP and aligned to achieve the TPP, and presentation material for trial-related advisory boards, investigators meetings, protocol training meetings for Novartis local medical organizations
 Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigators’ Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) and is responsible for delivering high quality clinical/medical input into regulatory documents and registration dossiers for assigned sections
 In collaboration with the relevant CTT members, conducts ongoing medical review of clinical trial data and manage patient safety; reports on trial data to safety and clinical boards (e.g., SMT, GCT, GPT); provides input into final analysis and interpretation of results including the development of Clinical Study Reports (CSRs), publications and internal/ external presentations; and ensures optimal execution of program Operational Plans including direct medical and operational support of trials as needed
 Supports GPH or GPMD in ensuring overall safety of the molecule in collaboration with the Brand Safety Leader for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents)
 May lead GCT, works closely with CTTs and may represent Clinical at GPT
 Supports the Franchise Therapeutic Area Head (TAH) by providing medical input into CDP and CTP reviews and contributing/driving development of disease/program clinical standards for programs and new disease areas
 As a medical expert, supports the GPH or GPMD in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
 Works closely with NIBR (Novartis Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
 Ensures career development of functional and direct reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
 Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
 Elaborates scenario development for Clinical Development to support decision analysis and optimal resource allocation in program. Supports team to manage, forecast, and allocate resources (FTEs and budget) for the clinical program as needed. Supports GPMD for timely execution of clinical deliverables within approved budget
 May serve on or lead global process improvement work streams, act as Subject Matter Experts for training or SOP development, and/or contributes to other Clinical Development line function initiatives
Minimum requirements . MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (ophthalmology, retina) required, with Medical Board certification preferred; Clinical practice experience ≥ 4 years (including residency) preferred

. Fluent oral and written English

. ≥ 3 years clinical trial experience with demonstrated ability to manage several trials in parallel with multidisciplinary trial teams

. Advanced knowledge of assigned therapeutic area is desired, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data

. Demonstrated knowledge and application of statistical analysis methodology; can identify trends and interpret/report results effectively

. Demonstrated ability to establish strong scientific partnership with key stakeholders

. Thorough knowledge of GCP, clinical trial design, statistics, and regulatory/clinical development process

. Managed and provided medical oversight for several trials in parallel or lead program sections with multidisciplinary trial teams in a matrix organization

. Excellent communication skills, written and oral

. Strong interpersonal skills

. Excellent negotiation and conflict resolution skills

. Resolves issues with minimal supervision and understand when to escalate