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1+ months

Executive Medical Director - Oncology

Kelly Services
Indianapolis, IN 46202
**Kelly Services is actively recruiting for an Executive Medical Director to support the creation of new cancer therapies utilizing targeted radioligands.**

**This is a Direct Hire, Remote opportunity. Candidate must be able to travel for team and client meetings within the U.S. and Canada.**


**Ideal candidate will be an MD (Board Certified or Eligible,) with oncology practice experience, outside of education. Must have industry experience with complex trial design knowledge and thorough** **understanding of oncology drug development and approval processes.**


Reporting to the EVP of Clinical Development, the Executive Director, Clinical Development is a leadership role reporting to the Executive Vice President, Clinical Development. The incumbent will provide leadership and strategic input into early and late stages of development plans, study designs, data collection, analysis plans, publication strategies, safety monitoring and product labeling. The role will provide leadership on translational and clinical research decisions in partnerships with preclinical scientists, Medical Monitors, Investigators, Key Opinion Leaders, Biostatisticians, Clinical Scientists, Data Management, Safety & Pharmacovigilance and Medical Writing. The role will be a key stakeholder at Health Authority engagements and cross-functional team discussions, including Regulatory, Clinical Operations, Biostatistics, CMC, Safety and at the Executive Level.


**Responsibilities include:**


+ Strategize and implement innovative early (First-in-Human), Proof of Concept and late (registrational) clinical development programs including clinical protocol design and overall development strategy

+ Directs the design, development and interpretation of clinical studies

+ Prepares clinical development plans that integrate pre-clinical or proof of concept findings to registrational strategies with integrating cross-functional alignment

+ Serves as the therapeutic leader for study team(s)

+ Work closely with Pharmacovigilance and Drug Safety to ensure accurate, timely and complete reporting of safety events

+ Provide leadership in the preparation of expedited and aggregate safety reports

+ Assist in the authoring and review of INDs, investigator brochures, protocols, informed consent forms, and clinical study reports.

+ Provide medical oversight of clinical trials and serve as Medical Monitor on designated trials or oversee assigned Medical Monitors at CROs or via contracting partnerships

+ Provide leadership on disease state training and medical expertise including the presentation of product background and clinical trial results

+ Collaborate with biostatistics to establish sample size scenarios, statistical analysis plans and other study deliverables

+ Lead publication plans and provide scientific and medical contributions to publications and presentations

+ Contribute to clinical documents within INDs/CTAs as well as NDAs/NDSs with strategic positioning of data, document review and writing.

+ Oversee clinical data review, trends and interpretation.

+ Contribute to regulatory activities, such as Briefing Document preparation, FDA interactions and Information Requests.

+ Contribute to and/or lead advisory boards, data safety monitoring boards and key opinion leader discussions.

+ Align departmental activities in support of corporate goals, as appropriate.

+ Manage and mentor clinical staff


Requirements


+ MD (or MD/PhD) with board eligibility or accreditation, preferably in Medical Oncology

+ Minimum 15 years experience in clinical research with at least 8 years in Industry

+ Thorough understanding of oncology drug development and approval processes

+ Knowledge of clinical pharmacology and its relationship to decision-making in early drug development.

+ Demonstrated success in translational and clinical study design, FDA discussions and data analysis

+ Experience with design, execution and analysis of Phase 1-3 clinical studies preferred.

+ Experience in theranostic development preferred

+ Technical understanding of eCTD submission requirements, the CFR, GCP/ICH.

+ At least 3 years experience managing direct reports

+ Excellent interpersonal, communication and presentation skills

+ Ability to manage multiple projects and shifting priorities


Competencies


+ Demonstrates leadership, flexibility, critical thinking, time management and problem-solving skills.

+ Proficiency in Excel, Word, and PowerPoint (required)

+ Ability to understand new scientific concepts and information and apply these in a changing environment

+ Inherent drive to cultivate collaboration, teamwork and professionalism

+ Organized with high attention to detail, accuracy and completeness

+ Demonstrates excelled organizational, problem solving and communication skills


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-07-15 Expires: 2022-10-13

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Executive Medical Director - Oncology

Kelly Services
Indianapolis, IN 46202

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