Director/Sr. Director, Medical Oncology Strategy - Remote

Project Management United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Director / Sr. Director - Medical Oncology Strategy to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.  

At Premier Research, we are science-minded and heart-centered. Join us.

Director / Sr. Director - Medical Oncology Strategy will work under leadership and guidance of VP Oncology Medical Strategy to provide medical support to the Oncology Franchise by writing medical considerations, and providing insights into RFIs, RFPs, proposals, bid defense meetings and any other tasks as assigned.

This role will be interacting with sponsors, partners, vendors, and multidisciplinary teams especially business development, oncology operations, medical informatics, medical affairs, regulatory, and others.

This is a high visibility role. Being a team player is a must. This role will be accountable for the scientific strategy of the assigned tasks and ensuring that the best possible support is extended to the oncology operations and business development team.
  • Provide expert advice and detailed clinical development strategies for allocated project, including protocol development, study design, investigator brochure development, regulatory strategy, planning, and submission
  • Provide expert review/opinion in regulatory documents, filings, and dossiers (IND’s/IMP’s, NDA’s, CTA’s etc)
  • Provide scientific and medical support and guidance to the operational teams in all relevant aspects of Premier’s projects

Such responsibilities may include:

  • Liaise and identify suitable key opinion leaders via professional network or feasibility assessment
  • Offer both general and therapeutic training including preparation of training materials
  • Review medical/scientific data as requested from Premier departments
  • Review documents produced by Medical Writing department and provide feedback and comments as needed
  • Provide consultation to project teams to assist client management and communication
  • Maintain current knowledge and overall awareness in the primary field of interest, clinical development in general and the assigned therapy area
  • Ability to perform overnight business travel, up to 30% a month
  • Any other duties that may be required by Line Manager for Premier Research
You'll Need
  • US and Canada candidates only – east coast hours highly desirable
  • MD – board certified or board eligible
  • Oncology fellowship or training
  • Minimum 10-12 years oncology clinical research experience
  • Minimum 3-4 years in oncology medical support roles or a similar role to this
  • Previous experience working with biotech, specialty pharma, or small pharma AND CRO is an advantage
  • Must have excellent communication skills including technical writing, public and formal speaking
  • Expert level of knowledge in oncology / hematology, clinical development, GCP and regulations pertinent to clinical research 
  • Flexible, approachable, and pleasant personality
  • Quick to respond to requests and close the loop
  • Experience in development and delivery of training materials and programs
  • Ability to learn and capacity to make decisions/recommendations despite ambiguity
  • Able to review, evaluate, interpret, and present complex data
  • Has a consultative communication and collaboration approach with the team and the customer
  • Able to handle and prioritize multiple assignments and to meet the deadline in a fast-paced working environment
  • Maintains a positive, results orientated work environment