Senior Clinical Program Leader (Ridgefield, CT, United States, Connecticut) at None

Description

The Senior Clinical Program Leader assumes global Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader. The Senior Clinical Program Leader has a medical leadership role for a project or a portion of a project in clinical development, usually at Start of Development through phase I-III. The Senior 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 a number of 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 Inflammation (Gastroenterology) at the International Multidisciplinary Core Teams and takes clinical development responsibility for the projects assigned, e.g. definition of Target Product Profiles, Clinical Development Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development.
• Provides medical oversight to the clinical trial program within their respective project during protocol development, conduct, analysis and reporting, and has responsibility for continuous benefit-risk assessment.
• Provides medical leadership in regulatory meetings and contributes to submission strategy, regulatory dossiers, safety issues.
• Serves as chairperson of the cross-functional Global Early Clinical Development (ECD) Team / Medical Sub-team (MST) dependent on project stage, and proposes members in collaboration with the (associate)TAH Medicine. Represents the ECD team / MST on the Core Team, and at the Therapeutic Area Leadership Committee (TALC), Clinical Expert Committee (CEC) and the Human Pharma Steering Committee (HPSC).
• Oversees and supports contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards.
• Reviews and approves publications within his/her project in collaboration with the (a) Medical Head.
• Identifies the need of studies to be conducted, and provides input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary.

Requirements

•    PhD or MD preferred, ideally with specialization in Gastroenterology, Immunology, or a closely related field. Strong clinical gastroenterology experience at a major academic medical center is highly desirable.
•    At least three (3) years of experience in the Pharmaceutical Industry.
•    Successful track record in planning, conduct and publication 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.
•    Proven adaptive mindset, with hands-on experience in the design and execution of early-phase clinical studies in immune-mediated diseases.
•    Ability to act with grace and resilience under pressure.
•    Good project management skills.
•    Previous contacts with regulatory authorities, 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 Data

This position offers a base salary typically between $250,000 and $394,000.  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.