Medical Director - HEMOC/Neurology

CTI Clinical Trial and Consulting Services•Covington, KY

2d•Hybrid

About The Position

The Medical Director will be responsible for growing and leading a therapeutic portfolio through their medical and clinical development expertise and by providing medical and safety monitoring of awarded clinical trials. The Medical Director will be responsible for playing a leadership role in shaping the strategy and vision of CTI’s medical program, with a special emphasis on cell and gene therapy, and fostering multi-disciplinary collaboration and cross-organizational initiatives. Candidates will have specialized training and experience in one of the following disciplines: neurology or Hematology/Oncology.

Requirements

Excellent communication, presentation, and interpersonal skills, including good command of English language (both written and spoken) is required
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 with the ability 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
Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Committed to the principles of collaboration, teamwork, civility, and respect
Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
Board-certified physician in chosen area of medical specialization
Medical degree from an accredited school
At least 3 years of clinical research/clinical development experience
Knowledge of ICH-GCP, clinical trial design, statistics, and regulatory/clinical development process
Previous experience in a CRO or industry role preferred

Responsibilities

Drive growth of a therapeutic area portfolio through medical and clinical development expertise and by providing medical oversight of awarded clinical trials
Participate in the lifecycle of CTI’s work from early engagement to clinical consulting to RFP and bid defenses to clinical trial execution and delivery
Accountable for medical oversight and management of awarded studies, including protocol review, eligibility discussions, oversight of medical issues, training of internal and site teams, safety review, and medical support of regulatory issues
Early engagement business development activities, including providing advice and recommendations on protocols and clinical development plans, assessing key needs of sponsors, and applying innovations
Responsible for working with a broad range of sponsors, creatively assessing opportunities, and developing strategies for trials and innovations for the execution of studies
Use clinical, scientific, and operational knowledge to harness data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for clinical development projects, studies, and trials, addressing the specific needs and challenges of each customer
Provide clinical and scientific expertise to all CTI departments as requested and collaborate closely with teams to develop integrated strategies for clinical trials and studies
Partner with the regulatory team on clinical development plans, target product profiles, regulatory submissions, interactions with health authorities, and protocol development
In partnership with Sales, Operations, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Along with other key experts, responsible for leading teams in developing focused proposals
Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this 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, identification of target site and principal investigator profiles, understanding the standard of care and competitive landscape, informing strategies for site and country selection and patient recruitment
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 therapeutic area strategy
Attends and presents at customer meeting, or bid defense or partnership meetings, as required
Responsible for staying current on industry pipeline and scientific and business landscape; does due diligence research of the therapeutic landscape; educates and informs CTI clinical and business teams about cutting-edge therapeutic developments
Drive thought leadership activities including presentations, publications, and interactions with the medical scientific community to connect key areas of growth and innovation that CTI is focused on. which include cell and gene therapy and rare disease, and groundbreaking strategies to optimize the execution of clinical trials, using data and patient-centered approaches