Director, Clinical Development Strategy Lead - Ridgefield, United States - BI Pharmaceuticals, Inc.

BI Pharmaceuticals, Inc.

Verified Company

Ridgefield, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

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 Strategy Team Member 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 Strategy Team Member 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 cocreate 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 [X
TA] 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 TAspecific early asset, evidence, governance, clinical development discussions across [X] 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 realtime support and cocreation 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 benefitrisk 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