Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.
Advance the CDP through internal management review.
Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol.
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.
Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.
Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).
Contribute to data review, interpretation and publication of clinical study results.
Represent Clinical Development at Health Authorities and incorporating advice into development strategy.
Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program.
Align company position on clinical strategy with partner in alliance projects.
Translate biology into clinic in close collaboration with research and translational medicine.
Evaluate clinical aspects of business development opportunities as needed.
Apply high ethical standards and work with integrity.

Requirements

Medical Doctor
board certified or equivalent in gastroenterology or allergy/immunology
completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent
more than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of gastroenterology
strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred
knowledge of drug development preferred
strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment
performance oriented with ability to work along agreed timelines and a focus on strategy and execution
outstanding communicator
excellent problem-solving, conflict-resolution and decision-making skills
fluent in English (verbal and written communication).

Benefits

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical development strategyclinical study protocoldata reviewclinical researchdrug developmentregulatory documentssubmission dossiersclinical studies executionGCPICH guidelines

Soft Skills

interpersonal skillscommunication skillspresentation skillsnegotiation skillsnetworking skillsproblem-solving skillsconflict-resolution skillsdecision-making skillsperformance orientedstrategic execution

Certifications

Medical Doctorboard certified in gastroenterologyboard certified in allergy/immunology