Senior Director

1 month ago

Redwood City CA, United States Antiva Biosciences, Inc. Full time
Senior Director / Vice President, Technical Operations Position Summary

Antiva Biosciences, Inc. a well-funded venture-backed clinical stage biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions and infections caused by HPV, is seeking a Senior Director / Vice President, Technical Operations leader to join its team. Reporting to the SVP, Pharmaceutical Development and Manufacturing, the Sr. Director / Vice President, Technical Operations will be responsible for providing strategic direction, technical leadership and operational execution for ensuring successful CMC development activities in support of Antiva’s clinical programs. This position will partner with CMC, Quality and Clinical functions as well as global CMO partners to provide technical leadership and direction to Antiva’s drug manufacturing efforts. The successful leader will partner with senior management in developing strategy and driving the technical activities for Antiva’s pharmaceutical development, innovation and technology development activities. This hands-on role will be responsible for collaboratively planning and executing phase appropriate development and manufacturing activities for drug-device combination products, managing contract manufacturers, integrating drug substance, drug product and analytical methods development, and partnering with cross-functional team members in supporting corporate goals.

Specific Responsibilities Include (but not limited to):
  • Provide technical leadership to the CMC team in the development of drug-device combination products. Support project goals and strategy for stage-appropriate development, efficiently manage budgets and resources (both internal and external), and ensure timely delivery of drug substance, drug product, and clinical supplies in alignment with project objectives. Partner with senior management in long-term strategy and policies development, and implementation consistent with current industry practices, preparation for Board meetings and partnering activities.
  • Develop stage-appropriate solutions for complex challenges, including cross-functional activities, and manage near-term and long-term plans. Define process development criteria, perform risk analysis and oversee scale-up incorporating QbD aspects into development. 
  • Build long-term strategic partnerships with contract organizations, collaborate with internal and external team members (consultants and contract vendors) in developing/authoring protocols and reports. Lead or support manufacturing records, method protocols and reports development, data analysis including trend analysis, deviations, out-of-trend and out-of-specification investigations and efficient closure of the investigations etc.
  • Effectively communicate cross-functionally with Toxicology, Quality Assurance, Regulatory Affairs, Clinical Operations, and Project Management, build consensus and ensure that corporate strategic objectives are accomplished.
  • Prepare CMC reports and Regulatory documents. Assist in maintaining CMC documentation systems, coordinate writing of CMC sections for Regulatory submissions.
Requirements
  • BA or BS degree with a minimum of 20 years of relevant experience in the pharmaceutical industry is required. PhD or an advanced degree in related discipline, is highly preferred.
  • Proven track record of strategic leadership and management with at least 10 years in a leadership/management role.
  • Demonstrated strong project and cross-functional team leadership, as well as people management and mentoring skills.
  • Thorough understanding and working experience in drug product development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
  • Strong problem-solving skills with strategic and sound technically driven decision-making ability.
  • Strong track record as technical lead with experience in manufacturing of cGMP materials to support global drug product supply.
  • Management of CMOs, CMC teams, excellent oral and written communication, organizational and interpersonal skills, building positive relationships across functional teams are required.
  • Understanding of drug-device, drug substance, drug product, analytical methods development, and clinical supplies management is desired.
  • Strong track record of collaborative working relationship with external vendors (i.e. CDMOs) which has led to successful outcomes for the business.
  • Ability to collaboratively work within a team environment, report on projects and drive them to conclusion.
  • Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines, and able to manage/mentor junior level colleagues as needed.
  • Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a small company environment.
  • Ability to proactively identify challenges, possess strategic foresight and implement appropriate course of action.
  • Excellent organizational, oral/written communication and time management skills are required.
  • Must be able to innovate, analyze and solve problems with minimal supervision and strong attention to detail.
  • Travel to CMOs as needed to support project need.
How to Apply

To apply, please mail or email your CV and cover letter to:

Antiva BioSciences, Inc.
Attn: Human Resources
555 Twin Dolphin Drive, Suite 620
Redwood City, CA 94065
Email:careers@antivabio.com

Antiva is an equal opportunity employer.

#J-18808-Ljbffr

  • Senior Director Regulatory Affairs

    1 day ago

    Redwood City, United States Meet Full time

    Senior Director, Regulatory Affairs (Generalist)Hybrid Role - 3 Days in Menlo Park, CAMeet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC...

  • Senior Director Regulatory Affairs

    22 hours ago

    Redwood City, United States Meet Full time

    Senior Director, Regulatory Affairs (Generalist)Hybrid Role - 3 Days in Menlo Park, CAMeet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affairs professional to join their team. This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC...

  • Senior Director, Product Management

    4 weeks ago

    Redwood City, United States Sumo Logic Full time

    Senior Director of Product Management Sumo Logic is a cloud-native SaaS data analytics platform that solves complex observability and security problems. Customers choose our product because it allows them to easily monitor, optimize, and secure their applications, systems, and infrastructures.  Sumo Logic is seeking a product management leader...

  • Director of Sales and Marketing

    18 hours ago

    Oklahoma City, United States Integral Senior Living Full time

    Emerald Square Senior Living - PO6, Oklahoma City, OK, US 6 days ago Requisition ID: 7136 Salary Range: Director of Sales and Marketing Vibrant community. Inspiring company culture. The mission of making tomorrow better than yesterday. Join ISL in making dreams come true! SUMMARY of Duties The Director of Sales and Marketing is responsible for increasing...

  • Director of Nursing

    4 weeks ago

    Nebraska City, United States Morton Senior Living Full time

    Director of Nursing (DON) Morton Senior Living, Nebraska City, NE  Sign on Bonus $5,000 If you want to work for a company that truly values and appreciates its employees, join Morton Senior Living We are seeking a talented and compassionate Director of Nursing (DON) to join our leadership team. If you are a dedicated, highly motivated, energetic, and...

  • Director of Nursing

    3 days ago

    Nebraska City, United States Morton Senior Living Full time

    Director of Nursing (DON) Morton Senior Living, Nebraska City, NE Sign on Bonus $5,000 If you want to work for a company that truly values and appreciates its employees, join Morton Senior Living We are seeking a talented and compassionate Director of Nursing (DON) to join our leadership team. If you are a dedicated, highly motivated, energetic, and...

  • Director Financial Planning Analysis

    3 weeks ago

    Redwood City, United States Imperva Full time

    DIRECTOR, FINANCIAL PLANNING & ANALYSIS reporting to the Vice President, Financial Planning & Analysis. The Director of FP&A will be a key leader within the FP&A team, focused on orchestrating the budgeting and forecasting cycles within the company, and producing relevant and actionable management reporting and analytics. This is a full-time position based...

  • Division Director of Resident Care

    2 weeks ago

    Oklahoma City, United States Morada Senior Living Full time

    About Morada Senior Living Morada Senior Living ranks prominently among the 5 largest senior housing providers in the US and is nationally renowned for luxury senior-living communities. With over 250 communities in nearly 40 states, and 15,000 dedicated employees, Morada Senior Living is one the largest and fastest growing senior living companies in the...

  • Division Director of Resident Care

    2 weeks ago

    Oklahoma City, United States Morada Senior Living Full time

    Job DescriptionJob DescriptionAbout Morada Senior LivingMorada Senior Living ranks prominently among the 5 largest senior housing providers in the US and is nationally renowned for luxury senior-living communities. With over 250 communities in nearly 40 states, and 15,000 dedicated employees, Morada Senior Living is one the largest and fastest growing senior...

  • Resident Care Director

    1 day ago

    Bullhead City, United States Davis Place Senior Living Full time

    Job DescriptionJob DescriptionResident Care Director (LVN)Vibrant community. Inspiring company culture. The mission of making tomorrow better than yesterday. Join ISL in making dreams come true!SUMMARY of Duties The Resident Care Director is responsible for coordinating resident care in order to ensure the residents remain as independent as possible for as...

  • Maintenance Director

    1 month ago

    Forest City, United States Navion Senior Living Full time

    Carolina Reserve of Laurel Park, a community of Navion Senior Solutions located in Hendersonville, NC, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed in all maintenance process...

  • Director of Dining Services

    7 days ago

    Kansas City, United States Tutera Senior Living & Health Care Full time

    Director of Dining Services NEW CONSTRUCTION SENIOR LIVING COMMUNITY – Chesterfield, MO If you want to work for a company that truly values and appreciates its employees, join our team! We have an exciting opportunity for a Director of Dining Services available at this new construction senior living community in the Chesterfield, MO area. If you are a...

  • Maintenance Director

    1 month ago

    Forest City, United States Navion Senior Solutions Full time

    Job DescriptionJob DescriptionCarolina Reserve of Laurel Park, a community of Navion Senior Solutions located in Hendersonville, NC, is seeking a Maintenance Director to join its rapidly growing team. A great Maintenance Director will have a solid understanding of plumbing and electrical systems as well as carpentry and other crafts. They will be well-versed...

  • Associate Director, Marketing

    3 weeks ago

    Redwood City, CA, United States Revolution Medicines Full time

    Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment...

  • Health Care Director Specialist

    4 weeks ago

    Oklahoma City, United States Legend Senior Living Full time

    Beautiful Environments, Caring Associates Are you ready for a dynamic work environment that champions quality senior care, one where your excellent leadership is utilized to manage the company’s vision to achieve industry-leading resident care goals? If so, our Health Care Director Specialist position may be the perfect job for you. Our focus is to...

  • Executive Director

    2 weeks ago

    Kansas City, United States Discovery Senior Living Full time

    About Morada Senior Living: Morada Senior Living, proudly part of the Discovery Senior Living family of operating companies, manages care- and lifestyle-focused senior living communities in Texas, Oklahoma, New Mexico, and Colorado. Our company, which was built on our “Pillars of Excellence,” employs thousands of vital Team Members and is committed to...

  • Maintenance Director

    1 day ago

    Sun City West, United States Solstice Senior Living, LLC Full time

    Job DescriptionJob DescriptionMaintenance Director For Senior Living CommunityRead job requirements below before applying:Must have at least 3 years management experience in a 200 plus apartment complex or Senior Living Community! Must have experience as a Maintenance Supervisor/Director! Must have knowledge of TELS-daily work order system, Rent Ready unit...

  • Director of AI/ML Development

    1 month ago

    Redwood City, United States Informatica Full time

    External Description: Build Your Career at Informatica We're looking for a diverse group of collaborators who believe data has the power to improve society. Adventurous, work-from-anywhere minds who value solving some of the world's most challenging problems. Here, employees are encouraged to push their boldest ideas forward, united by a passion to create a...

  • Sr Resident Care Director

    4 weeks ago

    kansas city, United States Sunrise Senior Living Full time

    Overview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like home. Our focus is doing what’s right for the resident. For me, that’s a big breath of fresh air."- Sunrise Leader  At Sunrise, our Senior Resident Care Director (Sr. RCD) is responsible for providing overall...

  • Senior GTM Recruiter

    4 weeks ago

    Redwood City, United States Zilliz Full time

    Job DescriptionJob DescriptionAbout ZillizZilliz is a fast-growing startup developing the industry's leading vector database company for enterprise-grade AI. Founded by the engineers behind Milvus, the world's most popular open-source vector database, the company builds next-generation database technologies to help organizations quickly create AI...