Head of Medical Experts, Therapeutic Dermatology

Das ist der Job

pGalderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.

Darum lohnt es sich

They must combine initiative with a sense of teamwork and collaboration. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. /ppAt Galderma, we actively give our teams reasons to believe in our bold 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. /ppbPosition Summary /b /ppIn 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. /ppEssential Functions /ppbLeadership and Management /b /pliMember of the Clinical Science Leadership Team /liliLead a global team of internal/external Medical Experts responsible for the medical/scientific input into global, Therapeutic Dermatology clinical development programs. /liliPlan, lead, allocate resources and organise the activities within the group in liaison with the other functional leaders to ensure achievement of set RD objectives. /liliPrepare and present regular updates and reports to senior management, stakeholders, and regulatory bodies on the status of a clinical development program. /liliDeveloped, train on and improve SOPs and working instructions related to Clinical Sciences clinical development programs. /liliContribute to the building of high performing teams across Galderma RD. /lipbMedical Scientific Expertise /b /pliWorks 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. /liliProvides 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. /liliServes 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) /liliAdvises investigators and/or CROs on medically relevant questions emerging during study execution /liliDevelops presentation materials for advisory boards, investigator meetings, protocol training meetings or other clinical events as required. /liliSupports ongoing review of clinical trial safety data, analysis, and interpretation in collaboration with global development team members /liliProvides medical input in development of TPPs and other relevant documents. /liliSupports development team on medical/scientific aspects of data review, SSRM, coding, edit checks, CRF, DMC, and other study documents. /liliAdvises investigators and/or CROs on medically relevant topics emerging during study implementation and conduct. /liliSupports Clinical Development team in preparation of study documents and clinical data review. /liliIn 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) /liliDefends medical positions at meetings with regulatory authorities or other interested parties. /liliProvides input, review and takes medical lead in preparation of the clinical CTD submission modules. /liliAddresses 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. /liliPlans and executes publication and clinical communication strategy in collaboration with Global Medical Affairs Teams. /lipOther duties as assigned /ppb Minimum Education, Knowledge, Skills, and Abilities /b /pliMedical Degree is required /liliDermatologist with experience in Therapeutic Dermatology and knowledge in clinical development preferred /liliMinimum of 10 years of drug development experience in Therapeutic Dermatology /liliMinimum of 5 years of demonstrated leadership, management, and accomplishment conducting clinical trials in Therapeutic Dermatology /liliExcellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP /liliExperience with regulatory submissions and health authority interactions is required /liliProven ability to interpret and present efficacy and safety data derived from clinical trials in Therapeutic Dermatology /liliDemonstrated technical knowledge of methodology of study designs in Therapeutic Dermatology /liliExperience in working with and managing CROs and consultant Medical Experts in Therapeutic Dermatology /liliExcellent interpersonal and communication skills with high learning agility /liliFluent oral and written English /lipbWorking Conditions Physical Requirements /b /ppThe 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. /ppWhile performing duties of this job, the employee may or may not be frequently/or occasionally required to: /pliStand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell. /liliClimb stairs or ride elevators. /liliLift and/or move up to 25 pounds. /liliUse close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. /liliManipulate keyboard or otherwise access computer, telephone and hand-held devices. /liliBe exposed to outside weather conditions while going in and out of office buildings. /liliBe exposed to moderate noise level usually in warehouse settings. /liliBe exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environments. /liliWillingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally.

We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology.

Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. /ppWe look for people who focus on getting results, embrace learning and bring a positive energy.

Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Travel estimated at 20%. /li