Director, Senior Clinical Program Leader - Rheumatology (Remote)
Boehringer Ingelheim
**Description**
The Director, Senior Clinical Program Leader assumes Clinical Development responsibilities supporting late-stage development projects, reporting to the Global Clinical Development Lead for Rheumatology. The Clinical Program Leader has a medical leadership role for a project or a portion of a project in clinical development, usually beginning after Proof of Concept (Phase IIb or III). The Clinical Program Leader provides medical/scientific, technical, and managerial directions to the plans, programs and procedures within their project and indication areas to effectively develop new compounds and/or oversee the optimization of the profile of existing compounds.
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.
**Duties & Responsibilities**
+ Represents and is responsible to the Therapeutic Area on various workstreams related to the asset being developed, including but not limited to development of trial design outline (TDO) and clinical trial protocol (CTP), pediatric investigational plan development, input into project analysis, results communication, etc. Additional work packages may include medical/scientific contributions to the Investigator Brochure, Company Core Data sheet, Annual Safety Report / IND Safety Reports, as well as preparation for the Milestones Release of Full Development and Release of Submission.
+ Provides medical oversight to the clinical trial program within their respective project and contributes to continuous benefit-risk assessment.
+ Provides medical leadership in regulatory meetings and contributes to submission strategy, regulatory dossiers, and regulatory authority interactions..
+ Oversees medical project budgets for the respective project(s).
+ Serves as the representative of the development team to leadership committees within Medicine, within the TA (Business Unit Portfolio Committee (BUPC)), and to Corporate Leadership (One Human Pharma Executive Committee (OneHPEC).
+ Oversees and supports contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards.
+ Reviews and approves scientific abstracts and publications within his/her project in collaboration with the Clinical Development Lead, Head of Medicine (HOM) or Head of Clinical Development, Inflammation.
+ Identifies and provides input to Medical Affairs evidence gaps, strategy documents, publications, and Product Maintenance and Optimization (PMO).
**Requirements**
+ MD (specialist in respective TA) and extensive experience across all stages of clinical drug development. Clinical Rheumatology experience (fellowship training) preferred.
OR
+ PhD with ten-plus (10+) years’ experience in Rheumatology or other related Therapeutic Areas and extensive experience across all stages of clinical drug development.
+ Ability to thoroughly evaluate key study concepts including background, sample size, statistics, design, timing, feasibility and budgeting.
+ Successful track record in planning, conducting and publishing of Basic Science and/or Clinical Research
+ Sound medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams, regional BI counterparts and external partners
+ Ability to act with grace and resilience under pressure
+ Good project management skills
+ Previous interactions with regulatory authorities, and participation in international societies and other relevant international stakeholders
+ Good communication and presentation skills
+ Excellent cross-functional collaboration skills and ability to work in virtual teams
**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 base salary range for this position is $250,000 to $394,000. 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 (https://www.boehringer-ingelheim.com/us/careers/explore-our-company/benefits-rewards) .
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.
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