Description

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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Director, Clinical Development Lead is responsible for ensuring that BI develops our pipeline assets from a clinical development perspective for asset success, leading up to launch. The incumbent does this by bringing together therapeutic area landscape knowledge, US external expert's insights, US healthcare dynamics, understanding of the US regulatory environment, and the clinical development experience to translate US medical needs, and gaps into an integrated strategic development plan that enables the US specific clinical development role in the overall BI market approach and informs medical affairs efforts where applicable.

The Director, Clinical Development Lead collaborates cross functionally across within the larger Clinical Development & Medical Affairs (CDMA) department (e.g., Medical Excellence, RWE, etc.) and across the organization (e.g., Marketing, Market Access, Analytics & Insights (A&I), HEOR, Clinical Operations, TMCP, Patient Services, Legal, Compliance, etc.) and with global counterparts to create, execute, measure, and adapt the clinical development strategy. The incumbent may lead a team of Clinical Development Therapeutic Area Leader.

Duties & Responsibilities

• Gives input to co-create the global clinical development plan to ensure that US specific market needs are met, including clinical trial design, choice of potential comparator, implementation of biomarker plan.
• Ensures that US voice is heard, e.g., including external experts' feedback and input to the overall clinical development plan and specific clinical protocols.
• Oversees product development for the therapeutic area throughout the lifecycle from early clinical development through approval, launch and loss of exclusivity.
• Works with the US TA, RWE, FBM, Strategic Engagement, and the global TA teams to lead and implement excellence in clinical development as well as the generation of a consolidated medical strategy and integrated evidence plan for associated products/indications that prioritize innovation and address meaningful gaps internally and externally.
• Works with US TAs, global medical, Clinical Development and Operations, Research and Development, Translational Medicine and CDMA leaders to promote synergies throughout the product lifecycle and provide input into clinical development early asset planning, Commercial strategies, and global medical strategies to ensure the success of launches and timely execution of prioritized evidence generation initiatives.
• Serves as member of the US Early Asset and US launch team to represents CDMA at TA-specific early asset, evidence, governance, clinical development discussions across associated products (e.g., global Clinical Expert Committee (CEC), global Evidence Teams, Human Pharma Steering Committee (HPSC)).
• Responsible for providing medical input into clinical development through real-time support and co-creation responsibilities for project 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, input into regulatory strategies and labeling discussions).
• Provides medical guidance and coordinate with the global Evidence Lead to contribute 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 on behalf of the US.
• Works closely with Field Based Medicine, Medical Strategy, and TA leadership to support contacts to external experts, contribute at advisory boards, adjudication committees and Safety Data Monitoring boards.
• Works with the US CDMA TA Head and respective stakeholders to identify and prioritize evidence generation programs and provide proactive input to Medical Affairs strategies, Medical Tactics, Integrated Business Plans, and other strategic documents as appropriate.
• Works with medical strategists (Medical Strategy Advisory, Customer Engagement Strategy, Customer Facing Excellence, and CDMA Strategy teams) to ensure clinical development pipeline, milestone, and strategies are understood and translated accurately into tactical next steps.
• Collaborates very closely with the respective Medical Affairs Strategy team member counterparts to ensure integration of US medical affairs strategic insights and market dynamics into the appropriate clinical development governance processes and decisions.

Requirements

• Master's degree in a medical/scientific discipline required; Doctoral degree (e.g., PhD, MD, DO, Pharm D) preferred.
• Minimum of eight (8) years of experience within the pharmaceutical industry preferably in Clinical Development roles, or equivalent.
• Proven clinical / academic experience in rheumatology/pulmonology and experience and knowledge in treatment of associated diseases. 
• Demonstrated experience in developing and execution of medical affairs tactics, business process improvement, product launch planning, and integrated evidence generation.
• Strong track record in developing and implementing clinical research / medical strategies including evaluation of value-oriented research and communication strategies.
• Deep scientific knowledge of the US healthcare system and regulatory landscape, including the needs of providers, patients, payers, and caregivers across the US within the therapeutic area(s).
• Ability to collaborate and lead with executive presence, positively influence performance excellence, and encourage innovation across all US therapeutic areas and levels.
• Ability to translate science into clinical patient value and operate within requirements of US / global SOPs and working instructions.
• Strong oral and written communication skills as well as the ability to present complex information to large scientific / academic audiences as well as to the media.
• Strong understanding of the therapeutic area(s), shifting US healthcare environment, medical, pharmaceutical and payor market dynamics, portfolio growth, and ability to manage multiple projects and identify risks in a fast-paced environment with a drive for results and sense of urgency to meet medical market needs.
• Ability to travel with some overnights away from home as required by the nature of the role.

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.

Desired Skills, Experience and Abilities

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.