Senior Vice President of Analytical Operations

2 weeks ago

California, United States The Higgins Group, Inc. Full time

COMPANY OVERVIEW

The Higgins Group, Inc. is a pioneering biotech firm focused on the discovery and advancement of innovative therapeutics aimed at addressing critical cancer challenges. Our approach is rooted in cutting-edge scientific research, drawing from natural and evolutionary insights to identify cancer targets and therapeutic strategies.

We are committed to pursuing groundbreaking treatment modalities for some of the most challenging cancers, particularly those associated with RAS mutations, which represent a significant portion of new cancer cases. As a new member of our team, you will collaborate with exceptional scientists dedicated to the discovery and development of transformative medicines for unmet cancer needs.

POSITION SUMMARY

The Vice President of Analytical Development & Quality Control will play a pivotal leadership role within the Pharmaceutical Development and Manufacturing (PDM) division. This individual will oversee analytical development and operational functions to support the clinical advancement and commercialization of our pipeline products. The role requires a blend of technical, organizational, and strategic leadership, ensuring that drug development and manufacturing processes are executed efficiently and in accordance with the integrated development plan and timelines.

Key Responsibilities:

  • Direct analytical development and operational activities from initial stages through to commercialization.
  • Oversee the formulation of analytical development strategies, ensuring the execution of functional tasks that support clinical development, regulatory submissions, product approvals, and market entry.
  • Review and authorize CMC documentation necessary for global regulatory submissions.
  • Lead cross-functional CMC teams for assigned projects, ensuring effective development and execution of CMC strategies.
  • Act as a core team member, communicating CMC strategies and project progress to key stakeholders while facilitating decision-making processes.
  • Collaborate with various teams (including drug substance, drug product, supply chain, quality, regulatory, clinical, and program management) to achieve CMC and program objectives.
  • Identify and assess potential suppliers for analytical development and QC functions, ensuring comprehensive risk evaluations.
  • Conduct site visits to contract development and manufacturing organizations (CDMOs) for vendor assessments and oversight of analytical activities as necessary.

Qualifications and Skills:

  • A PhD (or at least a Master’s degree) in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or a closely related discipline is preferred.
  • Significant experience in the pharmaceutical or biotech sectors, demonstrating a strong track record in technical expertise and leadership, particularly in analytical development for small molecules.
  • Extensive background in innovative drug development and commercial launches, with experience in global CMC regulatory submissions.
  • Proven strategic leadership and management capabilities, with a minimum of 10 years in a managerial role.
  • Strong project management and cross-functional team leadership skills, along with effective people management abilities.
  • In-depth understanding of innovative drug development and manufacturing processes, including GMP, quality systems, ICH guidelines, and regulatory requirements.
  • Extensive experience managing analytical activities at CDMOs.
  • Exceptional problem-solving skills, with a strategic and technically sound decision-making approach.
  • Excellent written and verbal communication skills, complemented by strong interpersonal abilities.
  • A collaborative team player with a dynamic and energetic approach to our fast-paced environment.

  • Senior Vice President of Analytical Operations

    2 weeks ago

    California, United States The Higgins Group, Inc. Full time

    COMPANY OVERVIEWThe Higgins Group, Inc. is a pioneering biotech firm focused on the discovery and advancement of innovative therapeutics aimed at addressing critical cancer challenges. Our research is deeply rooted in nature and evolutionary principles, which guide our understanding of cancer targets, disease mechanisms, and treatment methodologies.To...

  • Senior Vice President of Multifamily Operations

    2 weeks ago

    California, United States Shapell Properties, Inc. Full time

    Company OverviewShapell Properties, Inc. is a well-established leader in the real estate sector, with a rich history of innovative "build and hold" development practices that date back to 1955. The organization is committed to creating exceptional residential and commercial spaces that enhance the living experience of their clients. Shapell Properties values...

  • Senior Vice President of Ambulatory Operations

    2 weeks ago

    California, Missouri, United States Sutter Health Full time

    Organization:Sutter Health Administrative DivisionPosition Overview:The Senior Vice President of Ambulatory Operations is responsible for the strategic planning, oversight, and evaluation of market initiatives in key areas such as Imaging, Pharmacy, Genetic Counseling, Laboratory Services, and Ambulatory Surgery Centers. This role involves collaboration with...

  • Senior Vice President of Construction Operations

    7 days ago

    California, United States IR Pros Full time

    About IR Pros: We are a leading national organization comprising various synergistic divisions that specialize in Industrial Refrigeration, Construction, Service, Insulation, Cold Storage, and related services.Position Overview:The Senior Vice President of Construction Operations will oversee all facets of business management for a commercial construction...

  • Senior Vice President, Media Operations

    7 days ago

    California, United States Iron Mountain Full time

    About Iron Mountain At Iron Mountain, we recognize that effective work creates a positive influence on our clients, our workforce, and the environment. We are committed to attracting intelligent and dedicated individuals who can enhance the impact of their contributions. We specialize in providing sustainable solutions in records and information management,...

  • Senior Vice President, Client Relations

    7 days ago

    California, United States Energize Group Full time

    Position: Senior Vice President, Client RelationsLocation: Remote with travel flexibilityRole Overview:We are collaborating with Energize Group, a leading Global Analytics firm that specializes in delivering comprehensive solutions in Big Data, Machine Learning, Advanced Analytics, Data Management, and Data Visualization.In this pivotal role, you will...

  • Senior Vice President, Client Relations

    7 days ago

    California, United States Energize Group Full time

    Position: Senior Vice President, Client PartnershipsLocation: Remote with 25-50% travel in San FranciscoRole Overview:We are collaborating with a leading Global Analytics firm that specializes in delivering comprehensive solutions across Big Data, Machine Learning, Advanced Analytics, Data Management, and Data Visualization.In this pivotal role, you will act...

  • Senior Vice President, Client Relations

    7 days ago

    California, United States Energize Group Full time

    Position: Senior Vice President, Client PartnershipsLocation: Remote with 25-50% travelRole Overview:We are collaborating with Energize Group, a leading Global Analytics firm, dedicated to delivering comprehensive solutions in Big Data, Machine Learning, Advanced Analytics, Data Management, and Data Visualization.In this pivotal role, you will function as a...

  • Senior Vice President of Media Operations

    7 days ago

    California, United States Iron Mountain Full time

    Company OverviewAt Iron Mountain, we understand that effective work contributes positively to our clients, our workforce, and the environment. We are committed to bringing on board talented and dedicated individuals who are eager to make a difference. Whether you are beginning your career or seeking a new opportunity, we invite you to explore how you can...

  • Senior Vice President of Media Operations

    2 weeks ago

    California, United States Iron Mountain Full time

    About Iron MountainAt Iron Mountain, we recognize that effective work has a significant impact on our clients, our workforce, and the environment. We are seeking dedicated and intelligent individuals to join our mission. If you are looking to advance your career or explore new opportunities, we invite you to discover how you can enhance the value of your...

  • Vice President of Operations

    2 weeks ago

    California, United States Hamlyn Williams Full time

    Position Overview:The Vice President of Operations will be instrumental in steering the strategic direction and operational efficiency of our organization. This position requires a visionary leader who can spearhead the enhancement of our technological infrastructure, expand our customer base, and ensure optimal operational practices. The ideal candidate...

  • Senior Vice President of Safety Operations

    2 weeks ago

    California, United States The Everest Search Group Full time

    COMPANYThe Everest Search Group represents a well-established 3rd Party Logistics Provider with over 50 years of experience in the industry. This organization has positioned itself as a leader in logistics services across the United States, offering a range of solutions including warehousing, drayage, brokerage, and additional transportation services,...

  • Senior Vice President of Safety Operations

    2 weeks ago

    California, United States The Everest Search Group Full time

    COMPANYThe Everest Search Group represents a well-established 3rd Party Logistics Provider with over 50 years of industry experience, recognized as a leader in the logistics sector across the United States. Their comprehensive service portfolio encompasses warehousing, drayage, brokerage, and additional value-added transportation solutions, catering to...

  • Senior Vice President, Client Relations

    7 days ago

    California, United States Energize Group Full time

    Position: Vice President, Client PartnerRemote with 25-50% travelRole Overview:We are collaborating with a leading Global Analytics firm that specializes in delivering comprehensive solutions across Big Data, Machine Learning, Advanced Analytics, Data Management, and Data Visualization.In this pivotal role, you will function as a Senior Executive, working...

  • Senior Vice President, Client Relations

    7 days ago

    California, United States Energize Group Full time

    Position: Vice President, Client PartnerRemote with 25-50% travel requiredOverview:This role is with a leading Global Analytics firm that specializes in delivering comprehensive solutions across various domains including Big Data, Machine Learning, Advanced Analytics, Data Management, and Data Visualization.As a Senior Executive, you will engage with key...

  • Senior Vice President, Client Relations

    2 weeks ago

    California, United States Energize Group Full time

    Position: Vice President, Client PartnerLocation: Remote with 25-50% travelOverview:We are collaborating with a leading Global Analytics firm that specializes in delivering advanced solutions in Big Data, Machine Learning, Advanced Analytics, Data Management, and Data Visualization.In this pivotal role, you will act as a Senior Executive, working closely...

  • Vice President of Crisis Response

    2 weeks ago

    San Francisco, California, United States Visa Full time

    Job OverviewWe are looking for a dynamic and driven professional to oversee Visa's Crisis Response Program and various related initiatives, including policies and procedures. The Vice President will leverage strategic leadership, risk management techniques, analytical reasoning, and program oversight skills. This leader will collaborate with all management...

  • Senior Vice President of Environmental Safety

    7 days ago

    California, United States The Everest Search Group Full time

    COMPANYThe Everest Search Group represents a well-established 3rd Party Logistics Provider with over 50 years of experience in the industry. This organization is recognized as a leader in logistics services across the United States, offering a comprehensive range of solutions including warehousing, drayage, brokerage, and other value-added transportation...

  • Senior Vice President of ESG Advisory Services

    7 days ago

    California, Missouri, United States CLevelCrossing Full time

    Position at CLevelCrossingSenior Vice President of ESG Advisory ServicesCLevelCrossing is seeking a seasoned professional for the role of Senior Vice President of ESG Advisory Services to enhance its sustainability initiatives. This position is a unique opportunity to contribute to a growing sector focused on environmental, social, and governance (ESG)...

  • Senior Vice President of Real Estate Asset Management

    2 weeks ago

    California, United States Endeavor Full time

    Senior Vice President of Real Estate Asset Management | EndeavorEndeavor is collaborating with a prominent and successful commercial real estate investment firm, managing approximately $15 billion in assets under management (AUM). We are seeking a Senior Vice President of Asset Management to oversee the operational and financial performance of a diverse...