Clinical Medical Director R&D - Merz North America, Inc

Be a part of something bigger. Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, our product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with the highest standards of safety and efficacy.

As the Clinical Medical Director, you will have a key role within the Merz Aesthetics Clinical R&D team. Reporting to the Head of Global Clinical, and as a key member of the Clinical Leadership Team, you will be accountable for providing medical expertise to the development and implementation of clinical strategies for new innovative medical devices, medical device indications, and neurotoxin indications.

You will provide medical and clinical guidance during the clinical trial design, execution, and reporting for all pre-approval and post-market clinical studies. In addition to study level activities, the Medical Director will participate in program level activities including authoring/reviewing effectiveness summaries, clinical overviews, investigator brochures, risk management plans, publications and clinical sections of product labels.

Essential Duties and Responsibilities

• As an experienced physician, provide strategic guidance to the development of new substances/devices/indications across all franchises

• Provides medical and clinical guidance during clinical trial design, execution, and reporting for pre-approval clinical studies
• Contributes to developing the clinical trial design in close collaboration with other functions and, whenever needed, with external experts
• Facilitates, plans, and leads global advisory boards with internal stakeholders and external KOL physicians for current and future substances/devices/indications 
• Accountable for medical aspects of clinical trial design (e.g., study materials, endpoints and effectiveness measures)
• Provides medical input for the selection of investigators and sites for clinical trials
• Provides medical input for development of clinical outcome assessments
• Collaborates with a multidisciplinary team in the preparation (e.g., Investigator’s meeting, medical input for Informed Consent Form, Case Report Form, Independent Physician Assessments etc.) and execution of clinical trials
• If applicable, accountable for medical aspects of a Data Monitoring Committee

• Accountable for Medical Review of clinical study data for assigned projects (including guidance for responses to medical questions from sites)

• Provides medical input for Final Statistical Analysis Plan

• Evaluates and interprets study data and study results (tables, figures, and listings) and works in close collaboration with other functions to create main messages
• Accountable for the medical part of Scientific Advice Meetings (e.g., preparation for and participation in meetings with regulatory authorities
• Accountable for the medical part of the interaction with regulatory authorities
• Presents clinical study data by communicating accurate, succinct summaries of clinical results internally and externally
• In collaboration with other functions, develops the medical and clinical synopsis for Clinical Study Reports and Investigator’s Brochure
• Acts as a speaker and representative for R&D activities at medical education events, with internal and external stakeholders, and with key opinion leaders and clinical trial investigators
• Provides medical support for medical affairs activities including a review of proposed IITs
• Acts as co-author for scientific publications based on clinical study results
• Contributes with knowledge and experience for development, improvement and optimization of internal processes (e.g., in workshops, taskforces, SOPs, working instructions, etc.)
• Complies with current local and international regulations, laws, scientific and regulatory guidance, Good Clinical Practice, and internal policies and procedures

Job Related Qualifications/Skills

Professional Experience 

• MD with training and experience in the dermatology, plastic surgery or other related discipline (aesthetic medicine, neurotoxin-related indications preferred)
• Experience in conduct of medicinal product and/or medical device clinical trials (medical device preferred)

Knowledge, Skills, and Abilities

• Knowledge of Good Clinical Practice
• Skilled in protocol design, interpretation, and medical data review
• General therapeutic area knowledge
• Excellent written and oral communication (English fluency)
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization

Education

• MD

Based Salary Range 150k - 175k 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Research and Development