G1 Therapeutics
  • Durham, NC, USA
  • Full Time

G1 Therapeutics is seeking an experienced Medical Affairs professional with a specialization in oncology to join the team.

Responsibilities:

  • Build, grow and develop a high-functioning Medical Affairs organization ensuring that company practices are compliant with relevant regulations
  • Direct line management of Medical Affairs team; including MSLs, Medical Communications, Medical Information (Call Centers and information dissemination), Medical Affairs Operations (IITs, CME and Grants), Payer Medical Education, and Health Economics and Outcomes Research
  • Partner with the Product Development Team leaders for Medical Affairs initiatives and coordinate life cycle management with clinical development activities
  • Provide strategic input into the development plans supporting launch and commercialization
  • Oversee disease education activities for key opinion leaders and community oncologists; work with Commercial on disease education strategy
  • Ensure that all interactions and activities comply with G1 business guidances, policies, and SOPs, OIG, ACCME, FDA, and PharMA guidelines/policies 
  • Ensures plans, budget and resources are managed proactively.
  • Oversees the strategy and implementation of integrated HEOR plans in response to emerging clinical and health economic trends and the rapidly changing health care landscape
  • Drive creation and oversee execution of the following global strategic plans: Publication Plan, KOL/Advisory Board Plan, Investigator-Initiated Research Plan, Continuing Medical Education and Grant Plan to optimize product profile(s); Payer Medical Education Plan
  • Partner with Commercial for health economics and outcomes research activities, including Real World evidence studies
  • Drive the creation of effective presentations and tools that can be adopted and/or adapted globally (MSL slide decks, training platform materials, etc)
  • Provide Medical Affairs support of product access for patients through the planning and management of health outcomes and quality of life research (partnering with Clinical Operations and Clinical Development)
  • Provide Medical Affairs leadership to the MSL team and overall accountability for the development and management of relationships with Key Opinion Leaders (KOLs). Serve as a senior representative to KOLs, working in collaboration with Senior R&D colleagues similarly involved in providing strong medical and scientific presence
  • Provide clinical expertise in the development and review, not limited to, of the following: abstracts, posters, slides, manuscripts, educational materials, Investigator-Initiated Study protocols, Advisory Board meeting objectives, medical information letters, scientific educational grant requests, patient advocacy grant requests, disease strategy plans, and commercial brand plans
  • Serve as a senior representative of Medical Affairs to interact with key internal stakeholders: Marketing, Sales Training, Commercial, Business Development, Clinical Research and Development, Regulatory, and Product Leadership
  • Provide Medical leadership to the Commercial Team to assist in the development and execution of compliant commercial activities
  • Provide Medical Affairs strategic input for the elaboration of the brand plan(s); ensure execution of the Medical Affairs Strategy in line with the Brand Strategy

Requirements:

  • MD with 10+ years of experience within a corporate medical affairs function including direct management of Medical Affairs staff
  • Drug launch experience is required
  • Medical specialization in oncology; prior experience in academic medicine preferred
  • Board certified in oncology (highly desirable).
  • Strong relationships with a network of US KOLs required; in addition, European KOL relationships preferred
  • Understanding of regulatory compliance framework within which Medical Affairs operates (GCP and ICH regulatory guidances, clinicaltrials.gov, PhRMA and OIG guidelines), and other applicable statutes, laws and regulatory guidance
  • Experience and sound knowledge in conducting clinical trials (Phase I-IV)
  • Advanced scientific, technical reading, writing and editing skills
  • Ability to prioritize activities, manage multiple tasks within deadlines and act with minimal supervision in a complex and dynamic environment
  • Oversight of contract service providers and external consultants will be required.
  • Supervisory responsibility for in-house and field employees. Must possess strong management/leadership skills working in a matrix organization
  • Strong written and verbal communication skills, ability to present results clearly and concisely within the organization, including Board members as required, and external stakeholders
  • Demonstrated agility and success in a dynamic company / business environment where change is frequent and rapid understanding and alignment is paramount
  • Strong desire to work as part of many cross-functional teams consisting of technical, scientific, administrative, manufacturing / operations, and commercial team members
  • Able to travel both within the US and internationally as needed

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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