Associate Director, Investigational Sponsored Trials

Alternative Resources Company

Associate Director, Investigational Sponsored Trials

Associate Director, Investigational Sponsored Trials
 
The Medical Affairs Associate Director, Investigational Sponsored Trials works closely with various members of the organization from preclinical, clinical teams to representatives in the field. The role brings both strategic thinking and strong implementation skills and is critical to the successful execution and management of performance improvement efforts for Investigational Sponsored Trials (IST) program, managed by the Medical Affairs department. The Associate Director, Investigational Sponsored Trials independently oversees all areas of global IST management.
 
Responsibilities
The position will be responsible for the day-to-day management of the Investigator Sponsored Research (IST) Program, including contracting and budget and training interdepartmental team members. The position will also be integral to Medical Affairs functions including:
  • Managing the Oncology Review Committee process.
  • Serve as a liaison to internal and external customers in matters pertaining to the Investigator Sponsored Trials (IST) Research Program including but not limited to:
    • Accounts Payable
    • Clinical Science Liaisons
    • Clinical Development
    • Health Policy and Payment
    • Legal Department
    • Medical Affairs Team
    • S. Oncology Business Unit
    • Hospital Systems
    • Investigators and their staff
  • Answer inquiries regarding the protocols and process. Propose solutions for system improvement and information flow.
  • Work with external institutions, their legal departments and administrative systems for facilitate the contracting and payment aspect of the IST program.
  • Serve as a resource for the regulatory process/ FDA requirements/filings for the IST program. Responsible for IST guideline and process improvements.
  • Provide training sessions for cross-functional team members on all IST processing stages from new concept presentation to approval, including budget management and milestones and study implementation to IST completion.
  • Develop internal and external communications/plans for investigators and internal stakeholders.
  • Provides support in review of IST concepts and may serve as oversight of IST process and document management for record management (e.g. study concepts, clinical protocols and amendments, site recruitment updates, regulatory correspondence, contracts and budget management including milestone payments).
  • Review of regulatory guidance and precedence to inform on IST programs and regulatory strategies.
  • Lead, guide and oversee the strategy, oversight and implementation of process improvement initiatives within the IST program.
  • Provide support to efficient functioning of IST processes to ensure they meet required output performance and compliance expectations and appropriate control measures.
  • Preparing and presenting trial specific updates to management and cross functional areas
  • Participates in internal meetings, prepares reports presentations and administrative duties.
  • Meets with interdepartmental and cross-functional teams to ensure close collaborative working relationships with the process owners and relevant multifunctional areas, to ensure appropriate stakeholders’ feedback has been obtained and communication and trainings are appropriately delivered.
  • Supports department needs to develop and maintain relationships with key internal and external stakeholders.
 
Qualifications
  • Advanced degree with scientific/clinical background (MS, PharmD, PhD, MD)
  • 6+ years of experience in pharmaceutical or device industry (preferred)
  • 6+ years of clinical oncology experience (preferred)
  • A minimum of 3 years in clinical research in Oncology
  • Ability to communicate complex science and clinical data to the consumer level.
  • Working knowledge of legal and regulatory environment, with corresponding Guidelines (ACCME, AdVaMED, FDA, etc).
  • Must have excellent written and verbal skills (with the ability to give formal presentations), able to prepare materials for a wide variety of audiences from professional to patient.
  • Able to travel to meetings and seminars as needed (participates in competitive intelligence as needed) up to 25%.
  • Highly organized and results oriented, able to meet deadlines.
  • Must have the ability to adapt and change in a shifting environment.
  • A strategic, passionate, self-starter who works well in large and small teams, ability to work remotely.
  • Demonstrates thorough knowledge of clinical research and coaches others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
  • Able to understand and communicate complex scientific data, including clinical trial designs and related scientific concepts.
  • Strong critical thinking and problem-solving skills with excellent organizational and record-keeping skills.
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
  • Ability to maintain excellent working relationships with a broad range of trial staff internally and externally.
  • Experience in clinical budget planning, management, and reconciliation required; forecasting experience preferred.
  • Ability to work well in a team environment but also independently without significant oversight.
  • Advanced knowledge of the therapeutic area and company products.
  • Strong initiative and positive attitude, effective communication and interpersonal skills.
  • Able to write professional, scientific responses to HCP inquiries.
  • Communicates timely performance goals and expectations.
  • Creates atmosphere of accountability, self-motivated, time management skills.
  • Experienced in all aspects of Performance Plans.
  • Search engines and online library resources, database/document management.