Description

　　Clinical Program Leader (CPL) defines Clinical Development Strategy and is medically & scientifically responsible for the clinical development activities within TA Medicine remit. This includes continuous medical benefit and risk oversight for assigned projects. The incumbent will drive patient value, patient voice and quality of life & outcomes in line with Medicine Excellence goals.

　　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 a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

　　Duties & Responsibilities

　　Responsible 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).

　　Provides medical input into key 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 Medical subteam (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 (CEC, TALC, BRC and HPSC), as well as external bodies (Health Authorities, Adboards, Steering Committees, Medical/Patient Societies).

　　Responsible for optimal planning and execution of clinical studies from FIM throughout pivotal, ensuring integration of regional input. Drives operational decisions to implement evidence generation approaches and deliver the programs on time and within agreed budget.

　　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 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.

　　Contributes to the definition of strategy for data analysis and planning of Clinical Trial Report. Leads clinical interpretation of study results and ensures continuous risk/benefit assessment.

　　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.

　　Responsible 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.).

　　Provides input into Medical Affairs strategy, including identification of the need for Phase III/IV studies in collaboration with Medical Advisor, AHoM and HoM; provides contribution to Medical Affairs documents (e.g. Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary).

　　Ensures programs are delivered in compliance with GCP requirements and global regulatory and ethical standards.

　　Requirements

　　Director Program Leader Requirements:

　　MD (specialist in respective TA) from an accredited institution and extensive experience across all stages of clinical drug development.

　　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.

　　Commitment to high ethical standards and desire to transform lives of patients with unmet needs.

　　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.

　　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.

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　　Compensation Data

　　This position offers a base salary typically between $183,000 and $350,000.  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here. (https://www.boehringer-ingelheim.us/sites/us/files/files/2021-bi-benefits-overview.pdf)

　　All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.