(Job: 73-21BA)

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

Job Description:

In partnership with Contract Research Organization, the Clinical Quality Assurance Director will support the establishment, implementation and management of the quality assurance strategy across multiple studies. The CQA Director will assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients.

This role is accountable for GCP and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations).

Primary Responsibilities include but not limited to:

  • Provide GCP compliance advice and guidance to project teams, to achieve continuous quality improvement and effective quality management.
  • Interface with relevant stakeholders, including regulatory, clinical operation and clinical development to provide GCP expertise.
  • Prepare and conduct QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders, and interact with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
  • Proactively identify, analyze and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to promote the implementation of associated risk mitigation strategies.
  • Lead the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements).
  • Participate in the development/enhancement of QA procedures, guidance documents and audit tools.
  • Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents,
  • Act as a strong technical resource and is called upon to resolve GCP/PV issues based on knowledge of GCP, PV regulations and guidelines as well as local regulations.

Job Requirements:

  • BS/BA degree in a relevant area with 8+ years (Director) or 6+ (Associate Director) of experience in the pharmaceutical industry in a QA role.
  • Extensive vendor and site audit experience.
  • Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization.

To be considered for this opportunity, please submit your resume/CV referencing the position code to careers@ambrx.com. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.

(Job: 74-21BA)

About Ambrx:

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

Job Description:

We are seeking a highly motivated and experience Quality Assurance Document Control Manager to join our fast paced and growing Quality Team. The QA Document Control Manager will manage documents (both electronic and paper copies) within Quality Assurance, Regulatory Affairs, Clinical and other key departments to ensure that all GxP regulated documents are filed systematically and are easily retrievable. The candidate is primarily responsible for the implementation, management and maintenance of the document management system in accordance with the Quality System and relevant regulatory requirements. This position is also responsible for training staff on document control processes and procedures. In addition, the QA Document Control Manager will manage both paper and electronic records to ensure that controlled records are created, identified, changed, reviewed, retained, stored, and maintained in a manner that meets requirements.

Essential Duties and Responsibilities (including, but are not limited to):

  • Receive, file, and maintain all GxP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, computer system validation, …etc.
  • Assist in the selection and implementation of an electronic quality management system (eQMS).
  • Manage a Document Repository that tracks the receipt, revisions and archiving of all GxP documents; and prepare supportive process workflows and procedures to maintain efficiency and access for all users.
  • Maintain GxP audit files and assist with entry, tracking, and archiving of audit records.
  • Oversee and administer document lifecycle management as well as the change request process.
  • Assist in the maintenance of training records and documentation within our system.
  • Assist with and/or write SOPs for the creation and development of processes, archiving, and operations related to Document Control and other functions.
  • Perform review of documents submitted through the change control process for format, completeness, review and approvals.
  • Provide guidance and training to staff regarding document control processes.
  • Maintain overall document control structure within the document management system.
  • Define and maintain user roles and permissions in the document management system.
  • Resolve electronic document management system problems and issues in collaboration with users, system vendors and IT.
  • Support development of system and process improvements that would enhance compliance to documentation/training requirements.

 

Job Requirements:

  • Bachelor’s degree in Science or similar required.
  • >4 years of experience in a regulated environment and experience in managing and administering document control systems.
  • Knowledge of quality systems and regulatory compliance requirements within pharmaceutical or biotech environment.
  • Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization.                                                                                           

To be considered for this opportunity, please submit your resume/CV referencing the position code to careers@ambrx.com. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.

Job: 65-21BA; 66-21BA

About Ambrx:

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

Job Description:

We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) to join our fast paced and dedicated Clinical Operations team. This position is accountable for all activities related to the planning, timely execution, and efficient conduct of assigned clinical studies in support of Ambrx’s clinical development programs. The CTM will work independently and in a fast-paced team environment, manage both ongoing and new clinical trials, select vendors and oversee CRO activities, negotiate site budgets and contracts, draft study plans and manuals, review and track monitoring reports, review and approve clinical trial invoices, liaise with CMC, QA, and relevant stakeholders, ensure clinical conducts are in compliance with FDA regulations and ICH/GCP requirements while driving milestones according to established goals and timelines.

Job Requirements and Qualifications:

  • Bachelor’s degree in nursing or life sciences or equivalent
  • 8+ years experience managing all aspects of clinical trials
  • Excellent oral/written communication and organizational skills
  • Strong interpersonal skills and highly motivated
  • Ability to perform both independently and in a fast-paced and matrixed team environment
  • Demonstrated prior success in leading phase 1-3 US and international clinical studies including overseeing CRO(s) and site activities to ensure data integrity, PK samples and study drug reconciliation, and all clinical trials are conducted efficiently and in compliance with FDA regulations, ICH/GCP guidelines, and applicable country specific regulations and guidelines.
  • Provide inputs for protocol development and amendments; develop and implement ICFs, clinical study plans, manuals, and forms, such as Monitoring plan(s), Pharmacy Manual(s), CRF Completion Guidelines, Site Management Plans, Protocol Deviation Management Plan(s), Site Initiation Presentation, IRB/EC/REB regulatory packages etc.
  • Support preparation of regulatory submission documents Annual Reports, DSUR, IB, CSRs.
  • Manage central lab, PK samples and study drug reconciliation, address questions with sites, CRAs, and core lab(s), ensuring compliance with protocol and timely analysis and reporting of PK data.
  • Willing/able to travel 20% – 30%, valid, current passport

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits.

Job Code: 60-21BA

About Ambrx:

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into proteins, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, targeted immuno-oncology therapies, immunomodulatory smart cytokines, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

Overall Responsibilities:

We are seeking a highly motivated leader to be a key member of a fast-paced and dynamic organization. This position is a Clinical Development Leader who is a clinical development physician who plays a key role on the cross-functional drug development team.  This role will lead and advance the clinical development programs, in various Oncology indications through early development to global regulatory submissions.

The level will depend on the experience.

Specific Responsibilities:

  • Lead Clinical Development Strategy and Planning and demonstrate ownership of study designs and hands-on implementation in support of the overall product development plan, based on strong cross functional collaboration, clinical and scientific principles, knowledge of compliance and regulatory requirements, markets and emerging issues
  • Responsible for hands-on implement clinical trials, protocol related documents development, clinical data review, and other study execution activities
  • Prepare and present research data, lead and participate in the discussion of the strategies in tumor types such as breast, gastric, prostate, bladder, RCC, NSCLC, ovary, biliary and pancreatic cancers.
  • Lead clinical study teams, monitor overall study integrity, and review, interpretation, and communication of efficacy and safety data
  • Present at scientific, clinical, and regulatory meetings globally
  • Develop and maintain relationships with academic investigators, pharmaceutical and/or biotech partners/sponsors, KOL’s, and patient advocacy groups
  • Contribute to regulatory filings including authoring clinical sections for INDs, BLAs, NDAs, and other related documents
  • Collaborate closely with relevant functions including statistics and data science, clinical operation, regulatory and quality assurance, clinical pharmacology, drug safety & pharmacovigilance, Pre-clinical, CMC and other cross-functional teams.
  • Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
  • Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
  • Establish strong working relationships and collaborations with study investigators, key opinion leaders in drug development, external partners, and CROs.

Qualifications:

  •  MD required
  • Must have at least 8-15 years of experience as a high-performing hands-on physician with clinical development experience in conducting oncology clinical studies
  • Experience with ADCs (Antibody drug conjugates) is a plus
  • Must have a strong track record leading clinical trials efficiently and collaboratively with cross-functional teams, with excellent verbal and written communication skills
  • Must have outstanding presentation skills
  • Must maintain the highest level of data quality and integrity, to meet all relevant regulatory and health authority inspection requirements

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE

(Job Code: 27-20BA)

About Ambrx:

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into proteins, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, targeted immuno-oncology therapies, immunomodulatory smart cytokines, and long-acting therapeutic peptides for metabolic and cardiovascular disease.

We are seeking a highly motivated Associate Director or Director of Clinical Development to be a key member of a fast-paced and dynamic organization.

Overall Responsibilities:

This position is a Clinical Development Leader who is a clinical development physician who plays a key role on the cross-functional drug development team. This role will lead and advance the clinical development programs, in various Oncology indications through early development to global regulatory submissions.

The level will depend on the experience.

Specific Responsibilities:

  • Lead Clinical Development Strategy and Planning and demonstrate ownership of study designs and hands-on implementation in support of the overall product development plan, based on strong cross functional collaboration, clinical and scientific principles, knowledge of compliance and regulatory requirements, markets and emerging issues
  • Responsible for hands-on implement clinical trials, protocol related documents development, clinical data review, and other study execution activities
  • Prepare and present research data, lead and participate in the discussion of the strategies in tumor types such as breast, gastric, prostate, bladder, RCC, NSCLC, ovary, biliary and pancreatic cancers.
  • Lead clinical study teams, monitor overall study integrity, and review, interpretation, and communication of efficacy and safety data
  • Present at scientific, clinical, and regulatory meetings globally
  • Develop and maintain relationships with academic investigators, pharmaceutical and/or biotech partners/sponsors, KOL’s, and patient advocacy groups
  • Contribute to regulatory filings including authoring clinical sections for INDs, BLAs, NDAs, and other related documents
  • Collaborate closely with relevant functions including statistics and data science, clinical operation, regulatory and quality assurance, clinical pharmacology, drug safety & pharmacovigilance, Pre-clinical, CMC and other cross-functional teams.
  • Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
  • Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
  • Establish strong working relationships and collaborations with study investigators, key opinion leaders in drug development, external partners, and CROs.

Qualifications:

  • MD required
  • Must have at least 6-15 years of experience as a high-performing hands-on physician with clinical development experience in conducting oncology clinical studies
  • Experience with ADCs (Antibody drug conjugates) is a plus
  • Must have a strong track record leading clinical trials efficiently and collaboratively with cross-functional teams, with excellent verbal and written communication skills
  • Must have outstanding presentation skills
  • Must maintain the highest level of data quality and integrity, to meet all relevant regulatory and health authority inspection requirements

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. EOE

 (Job: -28-20BA) 

About Ambrx: 

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. 

The Vice President, Clinical Development, reports to the Chief Medical Officer, and will be a key member of drug development team, responsible for overseeing clinical development of our portfolio, helping to determine the strategy with efficient study implementation and execution across clinical development. 

Key Responsibilities: 

  • Lead and oversee an integrated clinical development team to drive and execute the clinical development strategy forward with an eye towards study implementation excellence, cross functional collaboration and innovation. 
  • Provide a vision of excellence in Clinical Development, in terms of standards, process and performance, and create and refine a clinical development strategy with a road-map for implementation. 
  • Clearly communicate and translate program strategies into clinical study concepts and support and mentor a systemic execution. 
  • Provide clinical and medical oversight for project teams, regulatory agency interactions, business units, manufacturing and other stakeholders. 
  • Collaborate with internal and external partners, investigators and KOLs to design and implement clinical studies. 
  • Monitor US, EU and Global regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines. 
  • Represent the company in various external forums as needed. Through outstanding communication skills, help to increase the profile of the company. 
  • Build mutually respectful and collaborative working relationships with other key functions. 

Requirements 

  • MD/PhD/PharmD with minimum 15 years of experience in Pharmaceutical industry in at least two therapeutic areas across phase I-IV, with at least 7 of these years in Clinical Development, 
  • An experienced leader who has successfully managed high performance cross-functional teams, worked in a matrix structure, with the ability to translate strategy into clear operational objectives. 
  • Demonstrate managerial skills to lead teams through change, especially growth, and ensure all actions taken are in line with the company culture of respecting the individual. 
  • Led a multi-site, multi-function global organization of significant size and complexity. Able to hold people accountable, provide thoughtful and accurate feedback; delegate appropriately, drive to develop and retain top talent. Uses sound judgement in hiring decisions. 
  • Has the gravitas, confidence and executive presence to operate with business leaders. Has scientific credibility and business acumen. 
  • Experience interfacing with regulatory agencies, thorough knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, EU, Japan). 
  • Excellent verbal and written communication skills and collaborative interpersonal skills. 
  • Anticipates future trends accurately and has a broad knowledge and perspective of regulatory implications on clinical development. 
  • Consistently achieves results. Pursues everything with energy, drive, and the need to finish. Persists in the face of challenges and setbacks. Always keeps the end in sight; pushes self and helps others to achieve results. 
  • Ability to lead a cross functional team through influence. Achieves this influence and level of leadership through maintenance of the highest levels of integrity and trust. Builds and sustains excellent relationships at multiple levels within the organization and with external key stakeholders such as federal regulatory agencies, clinical investigators, academics, and others. 
  • Decisively makes high-quality decisions, even when based on incomplete information in the face of uncertainty. Actively seeks input from pertinent sources to make timely and well-informed decisions. Skillfully separates opinions from facts and considers many perspectives objectively. Is respected by others for displaying superior judgement. 
  • Deals constructively with problems that may not have clear solutions or outcomes. Adapts quickly to changing conditions and is a calming leader to their group in times of uncertainty. 
  • Assumes the responsibility for the outcomes of others. Promotes a sense of urgency and establishes and enforces individual and team accountability. Is completely on top of what is going on and knows where things stand. Provides balanced feedback at the most critical times. Establishes clear responsibilities and processes for monitoring work and measuring results. 

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits. 

 (34-21BA) 

About Ambrx: 

Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. 

Job Description: 

We are seeking a motivated Clinical Supply Logistics Manager to join our fast paced and growing Clinical team. This position will be responsible for managing all aspects of clinical trial supplies and clinical sample logistics of multiple simultaneous oncology clinical studies. The candidate works closely with cross function teams including Clinical Ops, CMC, Bioassays, QA, Accounting, and other relevant stakeholders for clinical trial materials (CTM) supply forecast and inventory tracking, resupply planning and timelines. He or she is accountable for vendor selection and budget negotiation, importation and exportation permit for international shipments, distribution to domestic and international depots, central labs and clinical sites, inventory tracking and reconciliation, logistics of clinical PK sample inventory, shipment and testing to ensure timely data analysis and documentation, etc. Other activities include project documentation, communicating project performance, and support clinical trials in various areas. 

Job Requirements and Qualifications: 

  • BS or MS in a biological science field, or equivalent experience 
  • 10+ years of relevant experience in the biopharmaceutical industry. 
  • Prior experience managing global clinical trial supplies, depots and clinical central labs 
  • Ability to handle complex projects in the clinical development of all stages while managing priorities and ensuring regulatory compliance. 
  • Excellent oral/written communication and organizational skills, attention to details. 
  • Excellent organization skills, dedication and accountable, strong time management, self-starter with attention to details. 
  • Working knowledge of Coordinate cross functional CMC manufacturing activities to ensure timely and cost effective CTM resupply. 
  • Must be able to review clinical study tables and listings to ensure clinical data integrity. 
  • Regulatory inspection support experience preferred. 

To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code to careers@ambrx.com. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits.