Description
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
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
- 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 (e.g., 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.
- Accountable for alignment of strategy with operational excellence.
- 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 Pediatric Development Plans, and respective sections of regulatory documentation (CCDS, submission package, and health authority briefing documentation).
- Provides 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.
- Leads authoring of clinical abstracts, congress presentations and manuscripts (as appropriate).
- 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.)
- Liaises with the Digital Content Manager regarding new tools/technologies/best practices.
- Provides 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.
- Ensures programs are delivered in compliance with GCP requirements and global regulatory and ethical standards.
Requirements
- MD (specialist in respective TA) and extensive experience across all stages of clinical drug development.
OR
- PhD with ten-plus (10+) years’ experience in respective TA and extensive experience across all stages of clinical drug development.
- Commitment to high ethical standards and desire to transform lives of patients with unmet needs.
- Has a comprehensive knowledge of the Medicine strategy and vision as well as deep knowledge and understanding of the TA strategy and vision.
- Ability to thoroughly evaluate key study concepts including background, sample size, statistics, design, timing, feasibility and budgeting.
- 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.
- Able to deputize for more experienced roles.
Eligibility Requirements:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
Compensation
The position offers a base salary typically between $265,000 and $397,400. 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. Benefits include medical, dental and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance benefits, and other company-sponsored programs. For additional information regarding our benefits and Total Rewards offerings, please click here.
