(Senior) Clinical Program Lead Eye Health

The Position

Tasks & Responsibilities

• In alignment with the clinical development plans and as agreed with regulatory authorities (e.g. EMA and FDA), you conduct scientifically and clinically rigorous trials, contribute to relevant investigator`s brochures and develop clinical trial protocols, amendments, modifications of clinical investigational plans, clinical trial reports and scientific publications.
• Your tasks may include the responsibility for the creation of Target Product Profiles, design and execution of congruent, competitive, fast-to-patient Clinical Development Plans, Pediatric Investigational Plan, Medical Narrative, 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, Release of Submission.
• You are responsible for trial start-up, trial conduct, data read out and submission to achieve registration for novel assets.
• Furthermore, you work in close collaboration with Early Clinical Development team members, Medical Affairs and Market Access to ensure smooth transition of assets across various development phases.
• In your role you may be leading the Evidence Integration team also as a member of the Asset Team, or you may be leading a sub-evidence team.  You will develop and execute the wholistic asset evidence generation strategy to demonstrate competitive value of an asset throughout the life cycle in close collaboration with the Drug/Device and Value Network.  
• With your expertise, you ensure a good understanding of the relevant customer groups for AMD, DR/DME and IRDs (health authorities, key external experts, associations, patient groups, payers, etc.).
• You act as a decision maker in trial-related internal & external committee meetings, as delegated by the associate Head of Clinical Development Eye health.
• Furthermore, you are an externally recognized expert in the field and represent Boehringer Ingelheim to experts, regulatory authorities and organizations.
• In cooperation with the Associate Head of Clinical Development Eye Health, you exert medical and scientific leadership for cardiovascular indications within the TA EH.

Requirements

• MD with initial clinical and scientific experience in early and late clinical development, preferably Retinal diseases, or Ophthalmology. Clinical / Pharma experience in the US as well as experience with cell and/or gene therapies is a plus
• Some years of experience in clinical drug development within pharma industry, or comparable clinical development experience in an academic setting
• Solid regulatory knowledge and experience with various agencies like FDA and EMA
• Excellent leadership communication (oral and written) as well as negotiation and influencing skills
• Ability to act with grace and resilience under pressure as well as excellent presentation, training and facilitation skills

Additional Requirements for the Senior Role:

• MD with multiple years of clinical and scientific experience in early and late clinical development in Retinal diseases or Ophthalmology Clinical / Pharma experience in the US as well as experience with cell and/or gene therapies is a plus
• Long-term experience in Clinical Drug Development in pharma industry and/or academia, preferably in an international role
• In-depth regulatory expertise with prior successful interactions with various agencies like FDA and EMA
• Excellent leadership communication (oral and written) as well as negotiation and influencing skills
• Ability to act with grace and resilience under pressure as well as excellent presentation, training and facilitation skills
• Experience in direct or indirect leadership of internal teams, workstreams or individuals

Ready to contact us?