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Medical Director, Clinical Development

Location: California remote (may consider remote in other US locations)

(Job 2023-BN-09)

Ambrx (NASDAQ: AMAM) is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

The Medical Director, Clinical Development is responsible for leading the scientific and medical strategic planning and oversight of assigned clinical development program(s). May also serve in the capacity of Program Lead to drive execution of the clinical development plan.

Responsibilities:

  • Serve as medical subject-matter expert by maintaining and leveraging up-to-date knowledge in areas of therapeutic interest to the program.
  • Oversee the design and medical/scientific execution of clinical trials from pre-IND onwards to clearly meet program objectives, oversee patient safety, and ensure protocol compliance.
  • Promote a culture of innovation to bring forward creative development plans that maximize the potential of the asset.
  • Support the Chief Clinical Officer by providing medical input into Clinical Development Plan, Integrated Development Plan, and Clinical Trial Protocol reviews.
  • Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
  • Lead development of clinical sections of trial and program level regulatory documents
  • Act as a medical director for assigned studies including conducting ongoing reviews of medical/safety data; collaborates with others in development of case report forms, data management and statistical analysis plans; participates in investigator and other external presentations, meetings and other communications.
  • Act as a core member of the patient safety team, supporting overall program safety reporting in collaboration with Drug Safety team.
  • As a medical expert, supporting the Chief Clinical Officer in interactions with external and internal stakeholders and decision boards.
  • Drive execution of the assigned clinical program and/or clinical trial in partnership with Program Leads, functional management, and executive leadership.
  • If also serving in the role of Program Lead:
    • Collaborates with relevant teams and other groups to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve; acts as point of contact and project representative to portfolio team/ to enable decision-making, including information dissemination and the resolution of critical project issues.
    • Serves as the team’s champion by negotiating and influencing key internal stakeholders.
    • Creates a motivated, committed and engaged project team.
    • Models and expects effective team behavior to achieve the project goals.
    • Establishes cross-functional relationships with leaders from key cross-functional lines: Regulatory Affairs, Clinical Operations, Program Management, etc.
    • Leverages those relationships to manage key interdivisional interfaces on project issues including but not limited to Research, Development, Manufacturing and Competitive Intelligence
    • Leverages functional line expertise to achieve the team goals.
    • Collaborates with others to ensure consistency of processes
  • Supports clinical operations, clinical data management, biostatistics, clinical research organizations (CROs), etc. by acting as a point-of-contact for scientific/medical questions, other communications, and interactions, identifying investigators and sites.

Requirements:

  • MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in oncology preferred.
  • Minimum of 7 years of experience in clinical research or drug development within industry
  • Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
  • 5+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a in pharmaceutical industry required.
  • Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports.
  • Demonstrated ability to establish effective scientific partnerships with key stakeholders.
  • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
  • Previous global people management experience is preferred, though this may include management in a matrix environment.

Pay Scale:

The pay scale for this position is annualized at: $285,000 to $385,000, commensurate with experience. We believe this to be the possible compensation range for this role at the time of this posting, and we may modify this pay scale in the future.

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.

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Director, Clinical Pharmacology

(Job 2023-BN-11)

 

Ambrx (NASDAQ: AMAM) is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

Ambrx is seeking a highly motivated Director, Clinical Pharmacology to lead and actively contribute to the development and execution of clinical pharmacology and pharmacometrics strategies across the Ambrx portfolio; participates in the design of clinical and relevant non-clinical studies; and interprets, presents and reports clinical and non-clinical study results.

Primary Responsibilities:
The Director, Clinical Pharmacology ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

  • Acts as the lead clinical pharmacologist for multiple clinical stage programs.
  • Leads, and actively contributes to, the development of overarching clinical pharmacology strategies from IND to NDA (or BLA) to support regulatory submissions.
  • Leads the development of, and implements, optimal dose-finding strategies to ensure safe and effective advancement of clinical programs, including FIH dose selection, dose escalation and dose recommendation for the phase II and registration trials.
  • Leads, and actively contributes to the design and execution of clinical pharmacology studies to evaluate PK in special populations.
  • Leads, and actively contributes to, the design and execution of clinical drug-drug interaction and food effect studies following regulatory guidance.
  • Drafts Investigator’s Brochures (IBs), eCTD modules, and clinical study protocols in close partnership with clinical operations, medical, regulatory, biostatistics, and medical writing professionals.
  • Leads and performs PK analyses in non-compartmental model for the drug and/or metabolites.
  • Contribute to population PK/PD analyses and integrates this knowledge into the overall clinical development strategy(ies).
  • Evaluates and selects Contract Research Organizations (CROs) and manages/actively oversees outsourced PK and PK/PD.
  • Coaches and mentors team members.

Job Requirements:

  • PhD in a relevant scientific discipline OR a PharmD and a minimum of 5+ years of progressively responsible experience in a pharmaceutical, biotechnology or related environment
  • Demonstrated understanding or, and experience applying, clinical pharmacology concepts.
  • Familiar with regulatory guidance especially for drug interaction studies.
  • Highly proficient in performing NCA PK analysis using Phoenix WinNonlin.
  • Demonstrated expertise in developing and executing drug metabolism and pharmacokinetics studies.
  • Experience with common population PK/PD modeling software packages (such as NONMEM)
  • Preferred experience with common modeling software
  • Demonstrate understanding of formulation and toxicology.
  • Experience managing multiple projects with competing priorities.
  • Demonstrated experience in writing study reports and regulatory documents.
  • Ability to influence without direct authority.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively. as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Excellent management and interpersonal skills.
  • Up to 10% travel
  • Experiences in Oncology

Pay Scale:

The pay scale for this position is annualized at: $210,000 to $250,000, commensurate with experience.  We believe this to be the possible compensation range for this role at the time of this posting, and we may modify this pay scale in the future.

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.

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Associate Director, Clinical Data Management

(Job: 2023-BN-08)

 

Ambrx Biopharma, Inc. (NASDAQ: AMAM) is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

SUMMARY: 

Ambrx is seeking a highly dedicated Associate Director to collaborate with cross-functional teams (including medical, clinical science, biostatistics, PK, and biomarker analysts) to ensure complete and quality clinical data collection for oncology clinical trials. Oversees activities of data management CRO, organize and facilitate internal team data review, and performs hands-on data review as needed. Liaise with 3rd party vendors to facilitate routine data transfers in a consistent format. Contribute to the evaluation and implementation of clinical data collection systems, processes, and service providers.

 

KEY RESPONSIBILITIES:

  • Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.
  • Provide a high level of expertise in data management of oncology clinical studies, including areas such as: electronic Case Report Form (eCRF) design, electronic data capture (EDC) database design, data management plans, edit checks/data quality review plans, query resolution processes, data transfers, SAE/AE reconciliation, thesaurus coding processes, vendor oversight plans and database lock.
  • Effectively manage data management Clinical Research Organizations (CROs) to provide routine metrics, high compliance, and high-quality deliverables within timeline and budget
  • Oversee and conduct quality review of clinical trial data
  • Manage time and resource constraints across multiple projects.
  • Ensure data management components of the Trial Master File maintained by the CRO are complete and inspection-ready at all times.
  • Develop and implement new or improved processes for data management.
  • Participate in development of Request For Proposals (RFPs) and evaluation of vendors, products and proposals.
  • Provides oversight on quality and timeliness of task completion by direct reports.
  • Develops and implement training curriculum for data management activities and principles as required.

 

SUPERVISORY RESPONSIBILITIES:

  • Directly supervises zero to 4 employees or contractors
  • Indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors.

 

EDUCATION/EXPERIENCE/SKILLS:   

Education:

  • BS/BA degree in related discipline and 8 years of related experience; or,
  • MS/MA degree in related discipline and 7 years of related experience; or,
  • Equivalent combination of education and experience.

Experience:

  • Typically requires a minimum of 10 years of related experience and/or combination of experience and education/training.
  • Experience in Biotech/Pharmaceutical industry with oncology focus preferred.

Knowledge/Skills/Abilities:

  • Experience in solid-tumor oncology clinical trials required.
  • Expertise with EDC systems, e.g. RAVE, Inform
  • Experience with eCRF design for solid-tumor oncology
  • Deep understanding of the nuances of solid-tumor oncology data to facilitate development of data review checks and ability to drive/adjudicate/prioritize data queries.
  • Demonstrated success managing data management activities of Clinical Research Organizations (CROs).
  • Ability to train and oversee cross-functional staff on key data management tasks, including eCRF/EDC design, data quality review, and standardized data transfers.
  • Knowledge of Good Clinical Practices (GCP) is essential.

Pay Scale:

The annualized pay scale for this exempt position is: $155,000 to $180,000, commensurate with experience.  We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.

 

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.

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