Talent.com
Medical Affairs Director, Launch Lead

Medical Affairs Director, Launch Lead

Summit Therapeutics, Inc.Princeton, NJ, United States
30+ days ago
Job type
  • Full-time
Job description

Summit is seeking a highly skilled and experienced Medical Affairs Director to lead the medical strategy and tactical execution for the development and launch of ivonescimab in lung-related indications.

About Ivonescimab : Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials :

  • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
  • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  • HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Key Responsibilities : The successful candidate will be responsible for leading the medical strategy for the launch of ivonescimab in lung-related indications, developing and implementing pre-launch disease and product education programs, and ensuring the medical strategy and its execution align with regulatory requirements.

  • Drug Launch Leadership : Lead the medical strategy for the launch of ivonescimab in lung-related indications.
  • Pre-Launch Education : Develop and implement pre-launch disease and product education programs for healthcare professionals, patients, and other stakeholders.
  • Medical Strategy Development : Develop and implement medical strategies for ivonescimab in lung-related indications.
  • Regulatory and Compliance Alignment : Work closely with regulatory affairs to ensure compliance with all regulatory requirements.
  • Stakeholder Engagement : Build and maintain relationships with key opinion leaders, healthcare professionals, and other stakeholders.
  • Data Analysis and Interpretation : Analyze and interpret clinical data to provide medical insights and support decision-making processes.
  • Cross-Functional Collaboration : Collaborate with cross-functional teams to ensure the medical strategy supports commercial objectives.
  • Medical Information : Provide accurate and up-to-date medical information to internal and external stakeholders.
  • Compliance : Ensure all activities are conducted in compliance with relevant laws, regulations, and company policies.
  • Experience, Education, and Specialized Knowledge and Skills : The ideal candidate will have an MD, PhD, or PharmD, with a minimum of 10+ years of oncology-related experience in a medical affairs or combination of medical affairs and clinical development role.

  • Oncology drug launch experience required; lung cancer launch experience is highly preferred.
  • Proven track record in leading medical strategies and supporting launch and on-market oncology therapies.
  • Strong analytical and problem-solving skills with the ability to interpret complex scientific data.
  • Excellent communication and collaboration skills.
  • #J-18808-Ljbffr

    Create a job alert for this search

    Director Medical • Princeton, NJ, United States

    Related jobs
    • Promoted
    Medical Leader

    Medical Leader

    Anapol Enterprises, LLCPhiladelphia, Pennsylvania, US
    Full-time
    Medical Leader physician employment in Pennsylvania : .Philadelphia (desirable suburb), PA : Board Certified Chairman of Pathology is needed for a top-notch community hospital.Leadership experience...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Affairs Director, Launch Lead

    Medical Affairs Director, Launch Lead

    Summit Therapeutics Inc.Princeton, NJ, United States
    Full-time
    Job Title : Medical Affairs Director, Launch Lead.Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational. PD-1 with the anti-angiogenesis effects associated with blocking ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Medical Director - MASH - Medical Affairs

    Senior Medical Director - MASH - Medical Affairs

    Regeneron Pharmaceuticals, IncNJ, United States
    Full-time
    The Senior Medical Director, Medical Affairs – MASH Assets, will play a pivotal and highly visible strategic leadership role within the organization, reporting directly to the VP, Medical Affairs, ...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Director

    Medical Director

    Anapol Enterprises, LLCPhiladelphia, Pennsylvania, US
    Full-time
    Medical Director physician employment in Pennsylvania : .Philadelphia (desirable suburb), PA : Board Certified Chairman of Pathology is needed for a top-notch community hospital.Leadership experien...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Director

    Medical Director

    Neon NycNJ, United States
    Full-time
    United States - Mountain Lakes, New Jersey, United States - Parsippany, New Jersey.As a Medical Director, you will serve as a scientific expert and strategic partner, providing in-depth knowledge o...Show moreLast updated: 4 days ago
    • Promoted
    Senior Director, Managed Access Programs, Medical Evidence Generation (Worldwide Medical Affairs)

    Senior Director, Managed Access Programs, Medical Evidence Generation (Worldwide Medical Affairs)

    Scorpion TherapeuticsPrinceton, NJ, United States
    Full-time
    Those aren’t words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim...Show moreLast updated: 23 hours ago
    • Promoted
    Medical Director, Rare Disease

    Medical Director, Rare Disease

    Leo Pharma Inc.NJ, United States
    Full-time
    Select how often (in days) to receive an alert : .The Medical Director, Rare Disease, will be responsible for the development of medical strategy and tactics for generalized pustular psoriasis (GPP) ...Show moreLast updated: 4 days ago
    • Promoted
    Medical Affairs Director, Launch Lead

    Medical Affairs Director, Launch Lead

    Summit Therapeutics Sub, Inc.Princeton, NJ, United States
    Full-time
    Career Opportunities with Summit Therapeutics Sub, Inc.Careers At Summit Therapeutics Sub, Inc.Current job opportunities are posted here as they become available. Ivonescimab, known as SMT112, is a ...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Director, Pathology, Trinitas Regional Medical Center

    Medical Director, Pathology, Trinitas Regional Medical Center

    Rutgers UniversityNew Brunswick, NJ, United States
    Full-time
    The Department of Pathology and Laboratory Medicine at Rutgers Robert Wood Johnson Medical School invites applications for a faculty position at the Assistant Professor or Associate Professor level...Show moreLast updated: 4 days ago
    • Promoted
    Director of Medical Affairs Research (Remote)

    Director of Medical Affairs Research (Remote)

    Nestlé SABridgewater Township, NJ, United States
    Remote
    Full-time
    Director of Medical Affairs Research (Remote).At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these ...Show moreLast updated: 30+ days ago
    • Promoted
    Medical Director - Hematology / Oncology

    Medical Director - Hematology / Oncology

    HealthEcareers - ClientPennington, NJ, USA
    Full-time
    Capital Health, a leading health system in New Jersey dedicated to delivering outstanding cancer care, is seeking a dynamic and experienced. Medical Director for Hematology / Oncology.This individual ...Show moreLast updated: 16 days ago
    • Promoted
    Medical Director - Hematology Oncology

    Medical Director - Hematology Oncology

    International Society on Thrombosis and HemostasisNJ, United States
    Full-time +1
    Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology.Capi...Show moreLast updated: 4 days ago
    • Promoted
    Medical Director - Hematology / Oncology

    Medical Director - Hematology / Oncology

    Capital HealthPennington, US
    Full-time
    Capital Health, a leading health system in New Jersey dedicated to delivering outstanding cancer care, is seeking a dynamic and experienced. Medical Director for Hematology / Oncology.This individual ...Show moreLast updated: 17 days ago
    • Promoted
    Senior / Executive Medical Director

    Senior / Executive Medical Director

    HUTCHMEDFlorham Park, NJ, United States
    Full-time
    The (Senior / Executive) Medical Director (MD) - will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats...Show moreLast updated: 10 days ago
    • Promoted
    • New!
    Team Lead East - Senior Director, US Medical Affairs, GI Oncology, (Remote)

    Team Lead East - Senior Director, US Medical Affairs, GI Oncology, (Remote)

    Remote StaffingTrenton, NJ, US
    Remote
    Full-time
    Regional Medical Scientific Senior Director Team Lead.The Regional Medical Scientific Senior Director Team Lead (RMSD TL) is a credentialed therapeutic and disease expert who owns leadership, manag...Show moreLast updated: 8 hours ago
    • Promoted
    Medical Director - Endocrinology

    Medical Director - Endocrinology

    Capital HealthPennington, US
    Full-time
    Capital Health Medical Group (CHMG).New Jersey is expanding its endocrinology department and is seeking a.Medical Director of Endocrinology. As a key member of the Capital Health Medical Group (CHMG...Show moreLast updated: 30+ days ago
    • Promoted
    (Senior) Clinical Development Medical Director

    (Senior) Clinical Development Medical Director

    Novartis Group CompaniesEast Hanover, NJ, United States
    Full-time
    As a Clinical Development Medical Director in the Cardio Metabolic TA, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and repor...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Medical Affairs

    Senior Director, Medical Affairs

    Pharming Healthcare IncWarren, NJ, United States
    Full-time
    We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics.Pharming is headquartered in Leiden, the Netherlands, with.Our Vision is to develo...Show moreLast updated: 17 days ago