Job Archives TEST

Posted 2 months ago
The Head of Medical Affairs will spearhead the development of a world-class Medical Affairs organization at ArriVent to support the company’s expansion from a research and development focus to a company with robust, integrated commercial capabilities. This leader will design and execute a Medical Affairs strategy that enables the successful global launch of firmonertinib, ArriVent’s lead program currently in Phase 3 studies in EGFR-mutant non-small cell lung cancer (NSCLC). This person will interact with and influence executive leadership, engage cross-functionally, and take a hands-on approach in a lean organization. The ideal candidate will have experience in building industry-leading Medical Affairs capabilities and a proven track record of successful oncology drug launches in US and Europe. This person will lead the design, development and implementation of programs related to external dissemination of scientific information, internal training, insight gathering and evidence generation for ArriVent’s growing portfolio. Key Responsibilities:
  • Engage with internal stakeholders to build, implement and lead the US and ex-US Medical Affairs strategy, including publication, evidence generation and training plans, KOL engagement strategy and associated budgets in support of the launch of firmonertinib and pipeline programs
  • Recruit, build, and lead a global Medical Affairs team that includes Medical Science Liaisons (MSLs), Medical Communications and Information, Medical Education, Publications and Evidence Generation to drive the firmonertinib tactical plan
  • Serve as a subject matter expert within the organization and provide medical/clinical expertise to internal teams (Commercial, Manufacturing, Market Access, Regulatory, R&D, Business Development, Legal and Compliance)
  • Organize and lead advisory boards, study investigator interactions, congress engagements, and peer-to-peer discussions with key external stakeholders (e.g. healthcare professionals, patients, payers, advocacy groups, societies and alliance partners) with the goal of external education and internal dissemination of scientific insights to drive strategy
  • Develop a medical congress plan that will include identification of key medical meetings, participation logistics (e.g. booth), Medical Education events and thought leader engagements
  • Lead Global Medical Affairs-related research studies including Phase 4, ISTs and real-world data generation
  • Champion high standards of compliance, ethics, and patient safety, putting patients at the center of all actions
Required Qualifications and Skills:
  • An advanced doctorate (MD, Ph.D., PharmD) or equivalent degree in a medical/scientific specialty
  • 10+ years of experience in the biotech or pharmaceutical industry focused on medical affairs with direct, hands-on experience executing the various functions
  • Knowledge of the laws and regulations regarding scientific/medical communications, interactions with the healthcare community and working cross-functionally with a commercial team
  • Extensive field experience launching oncology products in the US market and support of brand plan development
  • Have a strong scientific acumen in lung cancer with a firm understanding of precision medicine
  • Proven ability to develop and grow productive relationships with thought leaders; existing relationships with lung cancer HCPs is preferred
  • Previous experience engaging health authorities and in guideline submissions (e.g. NCCN) preferred
  • Must be able to provide succinct, strategic, and actionable insights through strong presentation and communication skills engendering the trust and respect of internal and external stakeholders
  • Self-directed individual with a no-job-too big or too small attitude, who thrives in a fast-paced and energetic environment
  • Travel required to attend internal and external professional meetings

The Head of Medical Affairs will spearhead the development of a world-class Medical Affairs organization at ArriVent to support the company’s expansion from a research and development focus to a com...

Company Overview ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development and commercialization of differentiated medicines to address the unmet medical needs of patients with cancers. ArriVent seeks to utilize its team’s deep drug development experience to maximize the potential of its lead development candidate, firmonertinib, and advance a pipeline of novel therapeutics, such as next-generation antibody drug conjugates, through approval and commercialization in patients suffering from cancer, with an initial focus on solid tumors. Position Summary This position will play a critical role in expanding the ArriVent portfolio in the area of antibody drug conjugates (ADCs).  The individual will focus on leveraging next-generation ADC platforms and partnerships with leading ADC companies to develop a portfolio of novel ADCs for Oncology indications and advance these ADCs from research stage into the clinic.  This position will report into the Head of R&D. Responsibilities Include:
  • Serve as the Project Team leader for company’s non-clinical stage ADC programs
  • Together with partner company design and oversee execution of the ADC research plans from target nomination to clinical candidate selection
  • Work with internal cross functional team, partner company and contractors on the design and execution of non-clinical studies to support IND filing
  • Be overall accountable for the IND package and author relevant IND sections
  • Serve as a representative for the company on Joint Research Committee with partner company
  • Contribute to the further identification of partner companies with leading ADC technology for licensing and collaboration.
  • Represent the company at scientific conferences.
Experience & Qualifications:
  • Advanced scientific degree (PhD) in a Biological Science discipline
  • A minimum of 10 years of work experience beyond PhD including at least 7 years of ADC (or combination large molecule and ADC) research experience either as a research scientist, toxicologist or pharmacologist
  • Familiar with all aspects of ADC design, non-clinical characterization and manufacturing
  • First-hand knowledge of IND filing requirements for ADCs including, pharmacology and toxicology studies including bioanalytical methods
  • Experience authoring relevant scientific sections of IND
  • Experience leading cross functional Project Teams especially in partnerships/collaborations preferred.
  • Ability to work virtually and collaboratively with internal team, partners and consultants to advance non-clinical programs in a time-sensitive manner
  • Experience overseeing vendors including CROs
  • Strong problem-solving and quantitative skills
  • Excellent written, presentation and communication skills

Company Overview ArriVent is a clinical-stage biopharmaceutical company dedicated to the identification, development and commercialization of differentiated medicines to address the unmet medical need...