(Sr) Clinical Program Leader - Onco or INFL (Shanghai, China, Shanghai)

About Innovation Unit China

Innovation Unit China (China R&D Center) is a strategic innovation hub within Boehringer Ingelheim’s global R&D network, established to harness China’s rapidly evolving scientific capabilities and vibrant innovation ecosystem. By integrating Experimental Medicine, External Innovation, Development CMC, and Clinical Pharmacology & Non-clinical Safety Science, IU China connects promising science with early development expertise to accelerate high-potential opportunities, contribute to the global pipeline, and help accelerate breakthrough therapies for patients in China and around the world.

Responsibilities

- Accountable for development and execution of clinical development strategy for designated programs as part of a broader Integrated Asset Evidence Strategy, in alignment with TPP and in consultation with their supervisor (TL/aHOM/HOM).

Accountable for medical strategy to drive key clinical program deliverables throughout the clinical development cycle (design of Targeted Product Profiles, preparation for the Start of Development / Release of Phase I, and clinical phase transition milestones).

- As Evidence Lead a Sr. CPL leads and integrates the output of cross-functional evidence team (Clinical Operations, Biostatistics, Experimental Medicine, Pharmacovigilance, Regulatory, Medical Affairs, Market Access, Epidemiology, RWE etc.) assuming clinical development & budget responsibility for designated programs, and presents project related proposals and updates to internal governance committees, as well as external bodies (e.g., Health Authorities, Adboards, Steering Committees, Medical/Patient Societies).

- Accountable for optimal planning, interpretation and data presentation of clinical studies from FIM throughout pivotal studies, ensuring integration of regional input.

Accountable for alignment of strategy with operational excellence.

Ensures continuous risk/benefit assessment.

- Authors Investigator Brochures (with support from the Medical Writer and other contributors), Asset Evidence Plan (AEP) or similar documents, Trial Design Outline (TDO), Paediatric Development Plans, and respective sections of regulatory documentation (CCDS, submission package, and health authority briefing documentation).

Provides input to regulatory strategy (or, in the role as Evidence lead, oversees regulatory strategy) and leads clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses.

- Leads authoring of clinical abstracts, congress presentations and manuscripts (as appropriate).  Reviews and approves publications within his/her project(s) in collaboration with the (A)HoM.

Accountable for defining the medical digital strategy early in the project life cycle (e.g. suitable tool/vendors, qualification plan, validation plan for virtual/digital endpoints, etc.). Senior CPL will liaise with the Digital Content Manager regarding new tools/technologies/best practices.

Provides input into Medical Affairs strategy and deliverables (or, in the role as Evidence lead, oversees Medical Affairs strategy), including the medical chapters of the integrated brand plan and related key documents in collaboration with Medical Advisor, AHoM and HoM;

Ensures programs are delivered in compliance with GCP requirements and global regulatory and ethical standards.

- Competitive landscape analysis & scenario planning

Holds an in-depth understanding of the competitor landscape from the medical perspective including possible disruptive innovations and alternative treatments and is responsible for issue preparedness including scenario planning and anticipating competitor communication strategies. Develops competitive simulation exercises in order to challenge BIs own strategy vs. current and upcoming competitors.

Qualifications

- Min. 10 years clinical development experience within the Pharmaceutical Industry (Management experience considered a plus)

- 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 & understanding of the TA strategy and vision.

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

- Experience and comfort level with using digital channels and digital tools for enhancing evidence and value generation across all stages of development

- 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;

- Excellent cross-functional collaboration skills and ability to work in virtual teams and influence across matrix environment

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

- Advanced management skills

- Agile & effective working style

- Able to deputize for more experienced roles

- As Evidence Leads: Strong leadership skills as well as adequate ability to coach and mentor team members