Director/ Senior Associate Director, Clinical Program Leader, Retinal Health

Found in: Jooble US O C2 - 2 weeks ago

Maryland, United States BioCT Innovation Commons Full time

Description The role of Senior Clinical Program Leader (CPL) - Retinal health, assumes full medico-scientific and strategic leadership of clinical programs with the objective to accelerate clinical development and achieve regulatory approvals and reimbursable medicines. Senior CPL provides continuous medical benefit and risk oversight for assigned retinal assets. In this role, Senior CPL may supervise and mentor other CPLs assigned to their program/asset. Senior CPL may assume the responsibility of an Evidence Lead in the Asset Teams, leading the creation and execution of a holistic evidence generation strategy and integrating the deliverables of all medical functions as the leader of the Evidence team. The incumbent will drive patient value, patient voice and quality of life & outcomes in line with Medicine Excellence goals. The optimal candidate will be experienced in clinical research and would be an MD, Retinal Specialist with experience in late stage clinical trials.
We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Accountable for development and execution of clinical development strategy for designated programs as part of a broader Integrated Asset Evidence Strategy, in alignment with TPP and in consultation with their supervisor (TL/aHOM/HOM).
Accountable for medical strategy to drive key clinical program deliverables throughout the clinical development cycle (design of Targeted Product Profiles, preparation for the Start of Development / Release of Phase I, and clinical phase transition milestones).
Leads and integrates as chairperson the output of cross-functional evidence team (Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance, Regulatory, Medical Affairs, Market Access, Epidemiology, RWE etc) assuming clinical development & budget responsibility for designated programs, and presents project related proposals and updates to internal governance committees, as well as external bodies (eg, Health Authorities, Adboards, Steering Committees, Medical/Patient Societies).
Accountable for optimal planning, interpretation and data presentation of clinical studies from FIM throughout pivotal studies, ensuring integration of regional input.
Ensures continuous risk/benefit assessment.
Authors Investigator Brochures (with support from the Medical Writer and other contributors), Clinical Development Plans or similar documents, Core Clinical Trial Protocols, including the CTP strategy and core CTP elements within a document such as Trial Design Synopsis and Paediatric Development Plans, and respective sections of regulatory documentation (CCDS, submission package, and health authority briefing documentation).
Provides input to regulatory strategy (or, in the role as Evidence lead, oversees regulatory strategy) and leads clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses.
Reviews and approves publications within his/her project(s) in collaboration with the (A)HoM.
Accountable for defining the medical digital strategy early in the project life cycle (e.g. suitable tool/vendors, qualification plan, validation plan for virtual/digital endpoints, etc.). Senior CPL will liaise with the Digital Content Manager regarding new tools/technologies/best practices.
Provides input into Medical Affairs strategy and deliverables (or, in the role as Evidence lead, oversees Medical Affairs strategy), including the medical chapters of the integrated brand plan and related key documents in collaboration with Medical Advisor, AHoM and HoM.
Ensures programs are delivered in compliance with GCP requirements and global regulatory and ethical standards.
Alternatively, PhD from an accredited institution with ten-plus (10+) years of experience in Retinal Health or ophthalmology and extensive experience across all stages of clinical drug development.
Deep experience with clinical research in the relevant disease area.
Project and budget management experience for studies and ability to communicate clearly.
Proven track record on overseeing and running global clinical trial programs and working collaboratively with multiple stakeholders.
Has a comprehensive knowledge of the Medicine strategy and vision as well as deep knowledge and understanding of the TA strategy and vision.
Sound medical and scientific leadership to drive complex/high priority projects in collaboration with global matrix teams.
Very strong strategic mindset and excellent communications, influencing, presentation and training skills.
Proven ability to build internal relationships and exert influence in a matrix and virtual environment and external relationship with thought leaders, industry bodies, etc.
Track record of interaction with regulatory Affairs authority, international societies and other relevant stakeholders.
Advanced management skills.
Agile and effective working style.
Alternatively, PhD from an accredited institution with three to five (3-5) years of experience in respective TA and extensive experience across all stages of clinical drug development, clinical research and publication.
Experience with clinical research, experience in the relevant disease area, project and budget management for studies, ability to communicate clearly.
Sound medical and scientific leadership to drive high priority projects in collaboration with global matrix teams, regional counterparts.
Excellent cross-functional collaboration skills and ability to work in virtual teams.
Strong communications, training and presentation/facilitation skills.
Proven ability to build internal relationships and exert influence in a matrix and virtual environment and external relationship with thought leaders, industry bodies, etc.
Previous contacts with regulatory Affairs authority, international societies and other relevant international stakeholders.
Strong project management skills.
Agile and effective working style.
Compensation Data This position offers a base salary typically between $183,000 and $280,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.

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