Head of Medical Experts, Therapeutic Dermatology

Job description

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Position Summary In 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 Functions Leadership and Management Member of the Clinical Science Leadership Team Lead 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 the other functional leaders to ensure achievement of set R&D objectives. Prepare and present regular updates and reports to senior management, stakeholders, and regulatory bodies on the status of a clinical development program. Developed, train on and improve SOPs and working instructions related to Clinical Sciences & clinical development programs. Contribute to the building of high performing teams across Galderma R&D. Medical & Scientific Expertise Works 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. Provides clinical/medical strategy (e.g., scientific rationale, objectives, endpoints) to clinical development plans, Target Product Profiles,, protocols, investigator brochures, briefing packages, CTDs, draft labels, and other documents. Serves as lead Therapeutic Dermatology clinical/medical expert interacting with external stakeholders (e.g., regulatory authorities, CROs, key opinion leaders, advisory boards, patient advocacy groups), and internal stakeholders (e.g., Research, Global Medical Affairs, Global Product Strategy) Advises investigators and/or CROs on medically relevant questions emerging during study execution Develops presentation materials for advisory boards, investigator meetings, protocol training meetings or other clinical events as required. Supports ongoing review of clinical trial safety data, analysis, and interpretation in collaboration with global development team members Provides medical input in development of TPPs and other relevant documents. Supports development team on medical/scientific aspects of data review, SSRM, coding, edit checks, CRF, DMC, and other study documents. Advises investigators and/or CROs on medically relevant topics emerging during study implementation and conduct. Supports Clinical Development team in preparation of study documents and clinical data review. In collaboration with Global Safety Team, evaluates the Therapeutic Dermatology product benefit-risk profile, including all aspects relevant to patients, as well as external stakeholders (e.g., health authorities) Defends medical positions at meetings with regulatory authorities or other interested parties. Provides input, review and takes medical lead in preparation of the clinical CTD submission modules. Addresses medical Q&A 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. Plans and executes publication and clinical communication strategy in collaboration with Global Medical Affairs Teams. Other duties as assigned Minimum Education, Knowledge, Skills, and Abilities Medical 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 Requirements The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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. 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 moving between air-conditioned and non-air-conditioned environments. Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally. Travel estimated at 20%.