Head of Medical Experts, Therapeutic Dermatology

Das ist der Job

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Darum lohnt es sich

Position SummaryIn collaboration with global development teams, the Head of Medical Experts, Therapeutic Dermatology is responsible for providing lead medical input and expertise to clinical development programs conducted for Therapeutic Dermatology products.

Acting on the responsibility, the Head of Medical Experts, Therapeutic Dermatology, secures that clinical development is conducted in accordance with the Galderma quality management system, international standards and regulatory requirements.Essential FunctionsLeadership and ManagementLead a global team of internal/external Medical Experts responsible for the medical/scientific input into global therapeutic dermatology clinical development programs.Plan, lead, allocate resources and organise the activities within the group, in liaison with other functional leaders, to ensure achievement of set RD objectives.Prepare and present regular updates and reports to senior management, stakeholders and regulatory bodies on the status of a clinical development program.Develop, train on and improve SOPs and working instructions related to clinical sciences and clinical development programs.Contribute to the building of high‑performing teams across Galderma RD.Medical Scientific ExpertiseWork as part of a diverse, cross‑functional global team accountable for the design, implementation, execution, and submission/approval of clinical development plans in therapeutic dermatology to support the conduct of global clinical studies to meet regulatory requirements and budget targets.Provide clinical/medical strategy (scientific rationale, objectives, endpoints) to clinical development plans, Target Product Profiles, protocols, investigator brochures, briefing packages, CTDs, draft labels and other documents.Serve as the lead therapeutic dermatology clinical/medical expert interacting with external stakeholders (regulatory authorities, CROs, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders (research, global medical affairs, global product strategy).Advise investigators and/or CROs on medically relevant questions emerging during study execution.Develop presentation materials for advisory boards, investigator meetings, protocol training meetings or other clinical events as required.Support ongoing review of clinical trial safety data, analysis and interpretation in collaboration with global development team members.Provide medical input in the development of TPPs and other relevant documents.Support the development team on medical/scientific aspects of data review, SSRM, coding, edit checks, CRF, DMC and other study documents.Advise investigators and/or CROs on medically relevant topics emerging during study implementation and conduct.Support the clinical development team in preparation of study documents and clinical data review.In collaboration with the Global Safety Team, evaluate the therapeutic dermatology product benefit‑risk profile, including all aspects relevant to patients and external stakeholders such as health authorities.Defend medical positions at meetings with regulatory authorities or other interested parties.Provide input, review and take the medical lead in preparation of the clinical CTD submission modules.Address medical QA at all levels from protocol design to implementation of the study, interpretation of study outcomes and after submission of study results to regulatory authorities and other stakeholders.Plan and execute publication and clinical communication strategy in collaboration with global medical affairs teams.Other duties as assigned.QualificationsMedical Degree is required.Dermatologist with experience in therapeutic dermatology and knowledge in clinical development preferred.Minimum of 10 years of drug development experience in therapeutic dermatology.Minimum of 5 years of demonstrated leadership, management and accomplishment conducting clinical trials in therapeutic dermatology.Excellent knowledge of international guidelines ICH/GCP; basic knowledge of GMP/GDP.Experience with regulatory submissions and health authority interactions is required.Proven ability to interpret and present efficacy and safety data derived from clinical trials in therapeutic dermatology.Demonstrated technical knowledge of methodology of study designs in therapeutic dermatology.Experience in working with and managing CROs and consultant medical experts in therapeutic dermatology.Excellent interpersonal and communication skills with high learning agility.Fluent oral and written English.Working Conditions Physical RequirementsThe work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job.

Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally, is required. While performing duties of this job, the employee may or may not be frequently or occasionally required to: stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.

The employee may climb stairs or ride elevators; lift and/or move up to 25 pounds; use close vision, distance vision, peripheral vision, depth perception and ability to adjust focus; manipulate keyboard or otherwise access computer, telephone and hand‑held devices; be exposed to outside weather conditions while going in and out of office buildings; be exposed to moderate noise level usually in warehouse settings; be exposed to moving equipment, mechanical parts and/or high places; or move between air‑conditioned and non‑air‑conditioned environments.

Travel is estimated at 20%.