Early Clinical Development (ECD) Medical Director / Sr. Director - Remote

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JOB SUMMARY:

The IQVIA Early Clinical Development Center of Excellence (ECD COE) is a global cross functional C of E supporting early phase (FIH to Phas2a) opportunities in patients and healthy subjects across all therapeutic areas. We are searching for an experienced and enthusiastic individual to join our team.

The ECD Medical Director / Sr. Director is an individual with firsthand knowledge and expertise in the design and conduct of early phase trials.  The key remit of the role is to drive growth of the portfolio through scientific and clinical expertise. The position will be charged with using his/her clinical, scientific, and operational knowledge to develop innovative, early phase designs, improving safety, advancing scientific knowledge and decision making. The ECD Medical Director / Sr. Director will provide senior clinical and scientific early phase expertise to all IQVIA divisions and will collaborate closely with therapeutic area teams to develop integrated strategies for ECD studies.

The ECD C of E Medical Director / Sr. Director will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in their early clinical development plans. As a subject matter expert in ECD, the Medical Director will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.

RESPONSIBILITIES:

• Accountable and responsible for creating safe, innovative, early phase study designs, addressing the specific needs and challenges of each customer (such as starting dose calculations and dose escalation planning in FIH studies, Investigator brochure review and gap analyses to support FIH dosing)
• In partnership with therapeutic area teams, operations, sales, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Responsible for the inclusion of ECD medical and scientific considerations into proposals.
• Provide medical and scientific, and operational advice to internal stakeholders for proposals may include, but is not limited to:
  • Providing the strategy to protocol design/clinical development plan,
  • Mining data to address important clinical questions relevant to the study,
  • Reviewing the protocol for scientific/regulatory soundness and feasibility,

• Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys the ECD strategy.
• Attends and presents at customer meeting, or bid defense or partnership meetings, as required.
• Participates in strategic business development activities including early engagement opportunities, presentations to prospective clients and professional meetings.
• Maintains awareness of industry pipeline and scientific and business landscape; supports due diligence research of the ECD landscape
• Leads ECD thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities. 
• Participates in the IQVIA Medical and Scientific Review Group (MSRG) for early phase studies
• Participates in the medical safety assessments for ECD Partner sites including periodic reviews
• Providing medical Input and support to the Study TMA during clinical conduct when requested
• Attends regulatory scientific advisory meetings as required

REQUIREMENTS:

Scientific and Research Qualifications and Experience

• A leader with experience in early clinical development and the conduct of clinical trials in healthy volunteers and patients. A degree from an accredited and internationally recognized school is required. Preference will be given to candidates with formal training in clinical pharmacology. Highly qualified and experienced candidates with other terminal degrees such as a PhD will also be considered.
• 5+ years clinical research relevant experience, including hands on operational delivery and/or drug development experience
• Robust and current knowledge of scientific, clinical, regulatory and competitive landscape in clinical development
• Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and EMA guidance relating to the conduct of First in human studies.
• Demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering
• Strong clinical research skills and commitment to evidence-based and patient-centered clinical development

Professional Skills

• Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken)
• Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization
• Innovative and strategic thinker
• Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments
• Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required
• Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.
• Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results

Interpersonal Skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients. Maintains a positive outlook at work; handles criticism well and learns from it
• Ability to establish and maintain effective working relationships with a wide network of individuals e.g. coworkers, managers and customers
• Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues

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At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.