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, 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

• Represents specific Therapeutic Area 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

Clinical 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.

Senior Clinical 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 ten-plus (10+) years of experience in respective TA and extensive experience across all stages of clinical drug development.

• Deep experience with clinical research in the relevant disease area.

• Project and budget management experience for studies and ability to communicate clearly.

• Proven track record on overseeing and running global clinical trial programs and working collaboratively with multiple stakeholders.

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

• Has a comprehensive knowledge of the Medicine strategy and vision as well as deep knowledge and understanding of the TA strategy and vision.

• Ability to thoroughly evaluate key study concepts including background, sample size, statistics, design, timing, feasibility and budgeting.

• Sound medical and scientific leadership to drive complex/high priority projects in collaboration with global matrix teams.

• Very strong strategic mindset and excellent communications, influencing, presentation and training 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.

• Track record of interaction with regulatory Affairs authority, international societies and other relevant stakeholders.

• Advanced management skills.

• Agile and effective working style.

• Able to deputize for more experienced roles.

Compensation

This position offers a base salary typically between $183,000 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 click here. (https://www.boehringer-ingelheim.com/us/careers/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.