Executive Director Cancer Epidemiology

Outcomes Science & Services Boston, Massachusetts United States King of Prussia, Pennsylvania San Francisco, California Raleigh-Durham, North Carolina


Description

ConcertAI is the leading provider of precision oncology solutions for biopharma and healthcare, leveraging the largest collection of research-grade Real-world Data and the only broadly deployed oncology-specific AI solutions. Our mission is to improve translational sciences; accelerate therapeutic clinical development; and provide new capabilities for post-approval studies to accelerate needed medical innovations to patients and to improve patient outcomes. 

 ConcertAI has emerged as one of the highest-growth technology companies in Real-world Data and AI, backed by industry-leading private equity companies: SymphonyAI, Declaration Partners, Maverick Ventures, and Alliance|Bernstein. 

 

Role Summary

ConcertAI is a fast-growing healthcare research organization, leading the market in oncology healthcare data analytics. Our dynamic, fun, and highly experienced team is looking for a Director to join us. As an Executive Director in the Outcomes Science and Services (OSS) business unit, you will provide subject matter expertise (including Regulatory and cancer epidemiology) across the entire portfolio of research conducted using ConcertAI’s industry-leading and cutting-edge healthcare data resources. Our team operates in a cross-functional environment with representatives from other functions such as our Biostats, Data Curation, Data Products, and Data Science business units.

 As an Executive Director on our team, you will be reporting to the General Manager in the OSS business unit and will provide scientific leadership for health economic and outcomes research (HEOR) and external control arm (ECA) clinical studies. Your responsibilities will involve overseeing the scoping, budgeting, and execution of research projects dedicated to improving our understanding of the patient journey and treatment outcomes in the oncology space, as well as making meaningful impacts on patients' lives. Additionally, you will serve as an internal methods consultant within your area of expertise to ensure that our projects will deliver maximum value to our clients. This is a client-facing role where you will represent OSS as a clinical expert during business development activities. You will also take ownership of client relationships and be accountable for the design and implementation of the OSS team’s research to ensure client objectives are met. As an Executive Director you will directly supervise a team of Directors and Associate Directors, as well as have oversight of their direct reports. The Executive Director will be a key contributor to, and accountable for, corporate goals to progress the company’s portfolio of products.

  Responsibilities

  • Engages clients in early-stage business development work to help define their research needs and ensure that their priorities are clinically meaningful.
  • Advise on exploratory feasibility assessments and develops scopes of work to meet clients’ needs, including project budgets and timelines.
  • Drafts and reviews study proposals for appropriateness of research design, sample size, and planned analysis.
  • Supports large, priority client accounts as the research point of contact for strategic ideation and engagement, as well as the first option for addressing client requests and identifying supporting resources.
  • Builds strong relationships with clients to ensure continuous and consistent communication regarding their needs and ConcertAI’s research capabilities and performance.
  • Provides scientific expertise across the OSS team’s portfolio of research projects and advises on the methodological approach for principal investigators, data curators, programmers, consultants, and statisticians.
  • Consults with project teams on the clinical appropriateness of project scope and methods, as well as on the presentation of clinical study findings to client and external audiences.
  • Reviews study analyses and assesses validity of statistical output, as well as creates, reviews, and revises study deliverables for accuracy, consistency, thoroughness, and quality of scientific presentation.
  • Leads the development of abstracts, posters, and manuscripts to disseminate study findings at scientific congresses and within peer-reviewed journals.
  • Interacts internally and externally with ConcertAI staff and clients regarding existing, planned, or potential research.
  • Oversees hiring, training, and mentoring staff, and conducts personnel evaluations of direct reports in accordance with standard ConcertAI processes.
  • Assigns team members to research projects and works with colleagues to resolve issues related to competing priorities among research staff.
  • Contributes to development of internal methods, policies, and procedures to improve quality or efficiency of research within the OSS business unit.
  • Follows company policy and procedures regarding quality control, data security, and the ethical conduct of research involving human subjects, as well as the provisions of the HIPAA security and privacy rules.
  • Participates in other projects as assigned including principal investigator and contributing to internal initiatives.

 Requirements

  • Doctoral degree and minimum 10 years related research experience with an area of study in Epidemiology.
  • Mastery of the scientific research process, as well as an in-depth understanding of data management and statistical analysis relevant to the role.
  • Understanding of RWD applications and limitations including steps to leverage RWD for research such as data curation workflows, understanding of data provenance and traceability
  • Expertise in epidemiology with one or more relevant research methodologies such as health economics, epidemiology, biostatistics, or a related field.
  • Oversaw a portfolio of healthcare research projects using big healthcare data, such as claims or electronic medical records, or patient reported outcomes.
  • Experience leading clinical research studies within the oncology space related to one or more of the following tumor types: hematologic tumors, solid tumors, women’s health.
  • Ability to oversee multiple projects and deadlines, establish priorities for work activity, and solve practical problems.
  • Experience managing client relationships during the business development and execution phases of a project lifecycle.
  • Exceptional verbal and written communication skills with proven ability to clearly and convincingly present information to a wide range of internal and external audiences.
  • Substantial track record of research publications applying relevant methods and covering related research topics.
  • Established thought leadership within clinical oncology and real-world evidence space
  • Prior supervisory roles with responsibilities involving hiring, training, and mentoring staff.
  • Aptitude for understanding and applying best practices from documents such as safety rules, operating and maintenance instructions, procedure manuals, and correspondence.
  • Familiarity with basic productivity software (e.g., Microsoft Excel, Microsoft Word, Web Conferencing Applications)
  • Detail-oriented, highly motivated, results driven, and flexibility to work in a scaling environment.

 Regulatory Experience

  • Vast experience in cancer drug approval process, endpoints and management of milestones
  • Expertise in design I/E concepts for suitability of single arm trial supported by RW-control
  • Expertise in modern trial approaches (basket trials, adaptive trials design)
  • Understand limitations from trial suitability perspective and regulatory goals
  • Able to inform the limitations of RW in supporting a regulatory use case and offer alternatives (eg proxies, derivative variables)

Particular consideration will be given to applicants with the following qualifications

  • Working knowledge of external control arms or other use cases of real-world evidence to support regulatory decision-making.
  • Understanding of FDA regulatory requirements, ICH guidelines, and GCP.
  • Ex-role at the FDA or as consultant (teaching) to FDA a strong bonus
  • Experience in ideally directly or if not indirect consultation with FDA
  • Familiarity with statistical programming languages such as SAS, STATA, R, or SPSS.

 

Learn More About ConcertAI

ConcertAI is transforming how healthcare is delivered and dedicated to improving patient outcomes in oncology by offering innovative solutions on how data and intelligence are used to solve healthcare problems. We are creating something special in our culture, by building a collaborative, engaged, patient-focused, team approach to our mission. Our high-performance teams are looking to add great talent to the mix and we are hiring for the right mix of new skills and diverse mindset. Learn more about ConcertAI at www.concertai.com, or follow us on LinkedIn.