Senior Director, Head of Drug Substance

Found in: Appcast Linkedin GBL C2 - 3 weeks ago

Boston, United States Astria Therapeutics, Inc. Full time

Title: Senior Director, Head of Drug Substance


Position Overview:


Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.


We are seeking an experienced leader to join Astria as the Senior Director, Head of Drug Substance. This role will oversee all drug substance process development for the company and will play a key role in driving the portfolio forward from early process development through late stage, including process characterization, validation, and commercialization. The Head of Drug Substance will have a pivotal role in providing strategy, shaping future organizational design, and innovation for the PharmSci organization. This senior leadership position requires a strategic thinker with a deep understanding of development, including late stage and commercialization, exceptional relationship building, technical skills, and the ability to collaborate cross-functionally to ensure efficient and effective development throughout our programs at Astria. This role will also oversee all aspects of drug substance process and technology development and be a key partner for the other PharmSci functional heads. This leader will initially manage a small team of vendors and internal reports with an opportunity for future growth and reports to the SVP of Pharmaceutical Sciences and Technical Operations.


Responsibilities:


  • Lead drug substance team through preclinical and clinical development to commercialization across Astria’s pipeline. The role will have end to end responsibility of drug substance process development and technical support.
  • Drive, build, and enhance strategic relationships with CDMO and other partners to advance Astria’s patient-guided drug development pipeline.
  • Provide strategic and operational oversight, content creation of all regulatory documents and request for information.
  • Partner cross functionally broadly throughout the organization including program teams, research, clinical development, medical affairs, new product planning, regulatory affairs, and corporate communications.
  • Represent PharmSci holistically internally and externally as needed. Activities include due diligence, regulatory interactions, indication expansion, technology and innovation opportunities, project team and portfolio review committee.
  • Develop, own, and execute against the operational budget pertaining to drug substance including manufacturing and process development.
  • Provide mentorship and guidance to colleagues within the organization as well as outside of PharmSci.


Qualifications:


  • Ph.D. in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline with 12-15 years industrial bioprocess development/scale-up and manufacturing experience. The ideal candidate would have extensive experience in cell line and upstream process development. BS/MS with minimum of 15-20 years relevant industrial experience
  • 5 years’ direct management experience is required.
  • Strong leadership skills with experience defining the vision for the patient affairs function including strategic planning and supporting the development and growth of team members.
  • Proven track record of building trusting, meaningful relationships with key stakeholders, cross functional organizations and CMDO vendors and partners
  • Strong understanding of the legal, regulatory, and compliance environment, including a strong understanding of guidelines and best practices for drug substance development
  • Highly collaborative, able to successfully develop and maintain strong working relationships cross-functionally with colleagues and with external stakeholders.
  • Excellent communication and presentation skills
  • Travel: 25% (domestic and international)


Astria’s Commitment:


At Astria, we are committed to building a diverse team where every Astrian is empowered to bring their authentic self to work. We embrace a patient-first, people-always culture in which all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contribution.


People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families and communities.

  • Senior Director, Head of Drug Substance

    1 week ago

    Boston, United States Astria Therapeutics, Inc. Full time

    Title: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...

  • Senior Director, Head of Drug Substance

    3 days ago

    Boston, United States Astria Therapeutics, Inc. Full time

    Title: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...

  • Senior Director, Head of Drug Substance

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Astria Therapeutics, Inc. Full time

    Title: Senior Director, Head of Drug Substance Position Overview: Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for...

  • Senior Director, Drug Substance

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Spyre Therapeutics Full time

    Summary: The Senior Director, Drug Substance, Technical Operations, plays a key leadership role responsible for antibody drug substance development and manufacturing throughout product lifecycle. This strategic position is responsible for leading technical operations for drug substance development and manufacturing. The Senior Director, Drug Substance is a...

  • Director, Drug Substance

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Spyre Therapeutics Full time

    Summary: The Director, Drug Substance, Technical Operations, plays a leadership role responsible for antibody drug substance development and manufacturing throughout product lifecycle. This role provides the opportunity to help build the drug substance organization and involves close coordination with various teams including drug product, analytical...

  • Director, Drug Substance Manufacturing

    3 days ago

    Boston, United States Rapport Therapeutics Full time

    As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a...

  • Senior Medical Director, Drug Safety

    6 days ago

    Boston, United States Klein Hersh Full time

    Reporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information...

  • Senior Medical Director, Drug Safety

    1 week ago

    Boston, United States Klein Hersh Full time

    Reporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information...

  • Senior Director, Drug Product

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Spyre Therapeutics Full time

    Summary: The Senior Director, Drug Product (Technical Operations) position is a key leadership role responsible for antibody drug product development and manufacturing. The Senior Director, Drug Product is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer. This role provides the opportunity to...

  • Senior Director, Drug Safety and Pharmacovigilance

    2 weeks ago

    Boston, United States The Elle Group Full time

    The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a safety...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Boston, United States The Elle Group Full time

    The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a safety...

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: Jooble US O C2 - 1 week ago

    Boston, MA, United States The Elle Group Full time

    The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a safety...

  • Senior Medical Director, Global Drug Safety

    6 days ago

    Boston, United States AstraZeneca Full time

    This is what you will do:The Senior Medical Director provides global strategic and operational oversight of Alexions Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution through...

  • Senior Medical Director, Global Drug Safety

    18 hours ago

    Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...

  • Senior Medical Director, Global Drug Safety

    16 hours ago

    Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...

  • Director/Senior Director, Clinical Pharmacology

    16 hours ago

    Boston, United States Third Rock Ventures Full time

    As our clinical development portfolio evolves, Tango has an exciting new opportunity to join our team as a Director/Senior Director, Clinical Pharmacology. Reporting to our SVP, Pharmaceutical Sciences, you will be responsible for the design and implementation of clinical pharmacology aspects of patient trials and NDA-enabling clinical pharmacology studies....

  • Director/Senior Director, Clinical Pharmacology

    19 hours ago

    Boston, United States Tango Therapeutics Full time

    Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

  • Director, Microbial Process Development

    7 days ago

    Boston, United States HireMinds Full time

    Director, Bioprocess Development Boston, MA Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily...

  • Senior Director, CMC Operations

    Found in: Jooble US O C2 - 3 weeks ago

    Boston, MA, United States Spyre Therapeutics Full time

    Summary: The Senior Director, CMC Operations (Technical Operations) position is a key leadership role responsible for planning and execution of development, manufacturing, and supply chain activities. The Senior Director, CMC Operations is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer....

  • Clinical Director

    6 days ago

    Boston, United States ADDP Full time

    Schedule: Mon-Fri (With rotating on-call schedule on the weekends)Salary: TBDResponsibilities:Bay Cove Human Services, Inc.a leading Massachusetts human services organization, seeks a Clinical Director to join us in our mission to provide high-quality services to adults who face the life-long challenges of mental illness, aging and drug and alcohol...