Senior Director, Regulatory Affairs - Global Regulatory Leader

Summit Therapeutics plc•Menlo Park, CA

47d•$238,000 - $298,000•Onsite

About The Position

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 eg osimertinibHARMONi 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 NSCLCHARMONi 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 expressionIvonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe Ivonescimab was approved for marketing authorization in China in May 2024 Ivonescimab was granted Fast Track designation by the US Food & Drug Administration FDA for the HARMONi clinical trial setting Overview of Role The Senior Director of Regulatory Affairs Global Regulatory Leader is responsible for developing and implementing global strategies to secure INDCTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications for products in the oncology therapeutic area

Requirements

Bachelors degree in life sciences, pharmacy, biology, chemistry, pharmacology or related subject; Masters or Doctorate preferred
Minimum of 12 years experience in pharmaceutical regulatory activities with experience as lead regulatory product strategist in two or more major regions in addition to the US such as EU, Japan or China
Requires drug development experience in US & EU
Minimum of 5 years of proven experience in a strategic leadership role with strong project management skills
Experience working in a cross functional environment with multiple stakeholders and influencing cross functional teams
Experience interfacing with major government regulatory authorities
Strong communication and proactive negotiation skills
Experience developing and implementing successful global regulatory strategies
Attention to detail, accuracy and confidentiality
Clear and concise oral and written communication skills
Critical thinking, problem solving ability to work independently
Must be able to effectively multi-task and manage time sensitive and highly confidential documents
Communicate effectively and articulate complex ideas in an easily understandable way
Ability to successfully work in a fast paced, demanding and collaborative environment
Travel up to approximately 5%

Responsibilities

Leads global regulatory strategies for assigned products/indications through all phases of development
May include doing so in context of development collaborations and/or partnerships
Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers to include development of tumor landscape assessment to inform evolving development strategy
Advises management and cross functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards etc
Key internal leader and driver of regulatory policy and strategy for assigned products
Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
May lead the Labeling Regulatory Team for given products/indications
Proactively anticipates and mitigates regulatory risks
Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
Develops and implements acceleration strategies as appropriate
Accountable for ensuring that corporate goals are met with respect to assigned projects
Acts independently under direction of Vice President of Regulatory Affairs
Based on experience and scientific strengths expands TA knowledge of TA; provides coaching and mentoring for other regulatory members
Will have direct reports and contributes to the performance management for other RA team members
Makes decisions regarding regulatory work processes or operational plans and schedules in order to achieve the program objectives established
May advance the organizations goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate
Follows budget allocations
All other duties as assigned