Full Job Description
Lead the Future of Medicine as a Senior Clinical Program Lead in Obesity and Liver . To ensure the fastest and most focused path from strategy to patients, we are evolving our OneHP organization. Together, we are simplifying our structures, strengthening the accountability of Therapeutic Areas, and creating clear interfaces between Innovation and Business. This ensures that our assets are efficiently transformed into successful brands with the ultimate goal of delivering lasting value to patients around the world. Therefore, we are looking for a visionary leader to help shape our newly established Global Clinical Development organization. Now is the time to act , to strengthen our organization, empower our teams, and fulfill our responsibility to patients worldwide.
The Director, Senior Clinical Program Leader assumes full medico-scientific and strategic leadership of clinical programs with the objective to accelerate clinical development and achieve regulatory approvals and reimbursable medicines. This role provides continuous medical benefit and risk oversight for assigned assets. The incumbent may supervise and mentor other CPLs assigned to their program/asset.
Senior CPL may lead 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 Director, Senior Clinical Program Leader will drive patient value, patient voice and quality of life & outcomes in line with Medicine Excellence goals.
Duties & Responsibilities
3 Design and prepare clinical development plans, focusing on Phase I and II in Obesity & Liver indications.
3Accountable 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).
3Accountable 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).
3Leads 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 (e.g., Health Authorities, Adboards, Steering Committees, Medical/Patient Societies).
3Accountable for optimal planning, interpretation and data presentation of clinical studies from FIM throughout pivotal studies, ensuring integration of regional input.
3Accountable for alignment of strategy with operational excellence.
3Ensures continuous risk/benefit assessment.
3Authors 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 Pediatric Development Plans, and respective sections of regulatory documentation (CCDS, submission package, and health authority briefing documentation).
3Provides input to 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.
3Leads authoring of clinical abstracts, congress presentations and manuscripts (as appropriate).
3Reviews and approves publications within his/her project(s) in collaboration with the (A)HoM.
3Accountable 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.)
3Liaises with the Digital Content Manager regarding new tools/technologies/best practices.
3Provides input into Medical Affairs strategy and deliverables including the medical chapters of the integrated brand plan and related key documents in collaboration with Medical Advisor, AHoM and HoM.
3Ensures programs are delivered in compliance with GCP requirements and global regulatory and ethical standards.
Requirements
3MD (specialist in respective TA) and extensive experience across all stages of clinical drug development.
OR
3PhD with ten-plus (10+) years' experience in respective TA and extensive experience across all stages of clinical drug development.
3Commitment to high ethical standards and desire to transform lives of patients with unmet needs.
3Has a comprehensive knowledge of the Medicine strategy and vision as well as deep knowledge and understanding of the TA strategy and vision.
3Ability to thoroughly evaluate key study concepts including background, sample size, statistics, design, timing, feasibility and budgeting.
3Sound medical and scientific leadership to drive complex/high priority projects in collaboration with global matrix teams.
3Very strong strategic mindset and excellent communications, influencing, presentation and training skills.
3Proven ability to build internal relationships and exert influence in a matrix and virtual environment and external relationship with thought leaders, industry bodies, etc.
3Track record of interaction with regulatory Affairs authority, international societies and other relevant stakeholders.
3Advanced management skills.
3Agile and effective working style.
3Able to deputize for more experienced roles.
Eligibility Requirements :
3Must be legally authorized to work in the United States without restriction.
3Must be willing to take a drug test and post-offer physical (if required).
3Must be 18 years of age or older.
Compensation Data
The base salary range for this position is $250,000.00 to $394,000.00. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here .
Desired Skills, Experience and Abilities