Description

The Senior Clinical Program Leader or Clinical Program Leader- Cardio Renal Metabolic (CRM) assumes global Clinical Development responsibilities with a focus on cardiovascular and chronic kidney diseases. The 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-II. 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 opportunities 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.

******Candidate will be hired at level commensurate with experience and education*****

Duties & Responsibilities

• Represents CRM 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 Innovation Team Lead of the cross-functional Innovation Team dependent on project stage and proposes members in collaboration which represents the Innovation Team at the Innovation Unit Portfolio Committee (IUPC), IU Executive Committee (IUEC), and the One Human Pharma Committee (OneHP).
• 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) Head ExpMed CVD/CKD.
• 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

Senior Clinical Program Leader

• PhD or MD preferred, ideally with specialization in Cardiology, or a closely related field. Strong clinical CRM 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
• Proven adaptive mindset, with hands-on experience in the design and execution of early-phase clinical studies in immune-mediated diseases.

Clinical Program leader

• MD (specialist in cardiology) 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 immunology or related field 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.

Both Levels
• Sound medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams, regional BI counterparts and external partners.
• Excellent cross-functional collaboration skills and ability to work in virtual teams.
• Strong communications, training and presentation/facilitation skills.
• Strong project management skills.
• Previous contacts with regulatory Affairs authority, international societies and other relevant international stakeholders.

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 $220,000 and $350,000.  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