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.