Medical Director - HEMOC/Neurology

Myana; Covington (KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

CTI is seeking a Medical Director to grow and lead a therapeutic portfolio with medical and safety oversight of awarded trials. You will shape the medical program strategy, collaborate across functions, and supervise trial conduct, engaging with sponsors and health authorities.

This role requires an MD, board certification, 3+ years of clinical research/clinical development, and strong leadership in a matrix organization, with a focus on cell and gene therapy.

Qualifications

• MD required and board-certified in chosen medical specialty
• Minimum 3 years of clinical research/clinical development experience
• Knowledge of ICH-GCP, clinical trial design, statistics, and regulatory/clinical development processes
• Previous CRO or industry experience preferred

Responsibilities

• Provide medical oversight of awarded clinical trials including protocol review and safety oversight
• Lead lifecycle activities from early engagement to bid defenses and trial execution
• Develop and shepherd medical strategies and target product profiles in collaboration with regulatory teams
• Engage with sponsors, assess opportunities, and develop strategies for trials and innovations
• Provide scientific and clinical input to proposals and bid defenses to support winning proposals
• Mentor and train internal teams; foster cross-functional collaboration across departments

Skills

Leadership

Strategic thinker

Communication

Clinical development

ICH-GCP

Regulatory knowledge

Team management

Business acumen

Education

MD / Medical Degree

Job description

Job Purpose

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

What You'll Do

• 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

What You Bring

• 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

Why CTI?

• We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
• We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled - Click here to learn more about "The CTI Way"
• We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (Click here to learn more about our "CTI Cares" program)

If you are local to a CTI location...

Then you may be expected to come into the office and work an office or hybrid schedule depending on your role

Equal Opportunity Employer Veterans Disabled

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws.