Director, Senior Clinical Program Leader - Ridgefield
7 hours ago
Job 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 assessmentProvides 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 boardsReviews 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 .Our Company
Why Boehringer Ingelheim?
With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.
Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.
Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare.
Want to learn more? Visit https://www.boehringer-
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