Senior Medical Expert, Clinical Sciences

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.

Based in our Carlsbad office, the Senior Medical Expert, Clinical Sciences is responsible for providing scientific input, leadership, and expertise to clinical programs, including leadership and strategy to the Clinical Development Plan and execution of clinical protocol(s).

ESSENTION FUNCTIONS:

• Works as part of a diverse, cross-functional team accountable for the design, implementation, execution, and submission/approval of a Clinical Development Plan to support decision milestones, regulatory requirements, and budget targets.

• Provides clinical/medical strategy and input (i.e., scientific rationale, objectives, end points) to clinical development plans, Target Product Profiles, study outlines and protocols, investigator brochures, investigator meetings briefing packages, CTDs, draft labels, and other documentation as required.

• Serves as therapeutic area scientific and clinical/medical expert with external stakeholders (e.g., regulatory authorities, trial investigators & site staff, CRO, key opinion leaders, advisory boards, patient advocacy groups), and internal stakeholders (e.g., Research and Development, Global Medical Affairs, Global Product Strategy)

• Advises investigators and/or CROs on medically relevant questions emerging during study execution

• Develops presentation materials for trial-related advisory boards, investigator meetings, and protocol training meetings.

• Supports ongoing review of clinical trial safety data, medical monitoring activities, final analysis, and interpretation in collaboration with development team members

• Supports development team on medical/scientific aspects of data review, SSRM, coding, edit checks, CRF, DMC, and other study documents.

• Evaluates continuously the drug/medical device benefit risk profile, including the aspects of relevance to patients in clinical studies, as well as external stakeholders (e.g., health authorities) in collaboration with Global Clinical Safety team

• Supports publications and clinical communication strategy in conjunction with Global Medical Affairs

• Serve as member of the inspection readiness team in preparation of a regulatory inspections.

• Other duties as assigned

EDUCATION, KNOWLEDGE & SKILLS:

• MD required

• At least 3-5 years of industry experience required

• Dermatology or medical aesthetics clinical development experience required, injectable aesthetics experience preferred

• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP

• Excellent knowledge of relevant global regulations

• Excellent understanding of the drug and medical device development and risk management processes

• Excellent understanding of Clinical Trial Management including monitoring, study drug handling and data management

• Fluent in English (written and oral)

Employer’s Rights:

This job description does not list all the duties of the job.  You may be asked by your supervisors or managers to perform other duties.  You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time.  This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.