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Global Head of Clinical Development

4 months ago

Raleigh, United States Merz North America Full time

Serves a key role within the Merz Aesthetics Clinical Research and Development team, the Global Head of Clinical Development will be responsible for the development and implementation of clinical strategies for new innovative medical devices and new substances across the US and EU Clinical Development teams. Accountability for clinical aspects of Product Development from early evaluation through design and conduct of clinical studies, post-market studies, clinical research projects to register new products and indications in key countries, and maintenance of approved products.

Essential Duties and Responsibilities

  • Accountable for definition of clinical development strategy and development of clinical trial design:

    • Develops overall medical and clinical global strategy for the clinical development of new substances/devices/indications in close collaboration with other R&D functions and EMEA Clinical Development
    • Develops clinical trial design in close collaboration with other functions and, whenever needed, with external experts
  • Accountable for delivering high quality and timely documents (may be document owner or significant contributor):

    • Develops overall medical and clinical global strategy for the clinical development of new substances/devices/indications in close collaboration with other R&D functions and EMEA Clinical Development
    • Develops clinical trial design in close collaboration with other functions and, whenever needed, with external experts
  • Accountable for providing expertise to facilitate the trial set-up and conduct of clinical studies, including interpretation and reporting of study data:

    • Collaborates within a multidisciplinary team in the preparation of trial related documents (Investigator's meeting, Informed Consent Form, Case Report Form etc.)
    • Accountable for ongoing review of in-life trial data including protocol deviations (if applicable, establishes Data Monitoring Committee)
    • Provides input to Final Statistical Plan
    • Accountable for appropriate interpretation of study data and study results (tables, figures and listings) and creation of main messages
    • Accountable for development and validation of aesthetic photonumeric scales (where appropriate)
  • Accountable for clinical input to regulatory activities:

    • Accountable for clinical parts of regulatory documentation (e.g. meeting packages, investigational device exemption [IDE], investigational new drug [IND] applications, and sections of marketing applications [PMA/NDA/MAA/CTD] or other submissions depending on host country
    • Accountable for face-to-face, virtual, and written interactions with and submissions/responses to regulatory bodies, KOL / Scientific Advisory Board meetings and Investigator meetings
  • Accountable for clinical input for product maintenance activities:

    • Accountable for clinical parts of key product maintenance documents (e.g., PSUR, RMP, DSUR etc.)
    • Accountable for product maintenance documents in own responsibilities (e.g. CEP, CER, PMCF, PMCFR etc.)
    • Accountable for clinical input for appropriate disclosure of clinical trial data in public registries
  • Accountable for presentation and publication of clinical study results:

    • Accountable for the presentation of clinical study data by communicating accurate, succinct summaries of clinical results internally and externally
    • Acts as co-author for scientific publications based on clinical study results
  • Accountable for scientific due diligence for in-licensing opportunities, and early development:

    • Gives recommendation from scientific / clinical perspective toward decision(s) on in-licensing projects, business development initiatives and early development projects
  • Support organizational development and compliance:

    • 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
  • Support of key Merz Aesthetics business partners:

    • Provide clinical support to key business partners including but not limited to Commercial, Strategic Marketing, Medical Affairs, and Legal as necessary
  • Accountable for functional line management:

    • Accountable for Project Team resourcing (Clin Dev team member or R&D lead)
    • Functional management of Head of Clinical development US and Head of Clinical Development EU and their teams comprised of Clinical Scientists / Clinical Associates / Scientific Experts (PhD) and/or Medical Advisors (MD)
    • Ability to coach and mentor as required
Job Related Qualifications / Skills

Professional Experience
  • Required:

    • 10yrs to 15yrs Experience in clinical research including designing and conducting clinical studies
    • Competency of methodology in development and review of scientific and essential clinical trial / regulatory document
  • Preferred:

    • Experience and competency in the clinical field of interest (e.g. aesthetic medicine, neurotoxin-related indications)
Knowledge, Skills, and Abilities
  • Required:

    • Fluent in written and verbal business English
    • Ability to engage in an open, constructive and continuous dialogue
    • Ability to travel (domestic and international travel is required)
    • Ability to work independently and as part of a team
    • Strong ability to work collaboratively and to respect other working cultures
    • Ability to delegate
    • Experienced user Microsoft Office (Word, PowerPoint, Excel)
    • Experience in literature search
    • Team player with strong communication and presentation skills
    • Highly motivated, self-driven and dependable
Education
  • Required:

    • Medical Degree or PhD


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)