Senior Director, Global Clinical Program Lead

AstraZeneca • Boston, MA

1d • $288,059 - $432,089

About The Position

As a Senior Director, Global Clinical Program Lead, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The successful Study and Program Clinical Lead in Late Phase CVRM (Cardiovascular, Renal, and Metabolic diseases) will be responsible for the design, conduct, monitoring, data interpretation and reporting of clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as will allow for the intended label indication and price in markets globally. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.

Requirements

• Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent, and/or a graduate of a scientific doctorate (e.g. PhD or PharmD) or equivalent in a scientific discipline or Pharmaceutical Medicine
• 3+ years clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
• Good knowledge of biostatistics, global regulatory environment and pharmacovigilance
• Proven teamwork and collaboration skills
• Fluent in oral and written English
• Good presentation skills and effective communication
• Leadership qualities, with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting
• Agile responsiveness to scientific data
• Credibility in scientific and commercial environments

Nice To Haves

• Good general medical knowledge preferably in nephrology, cardiology, metabolic, or NASH
• Preferably 3-5 years in the pharmaceutical industry, with an understanding of R&D, particularly of major clinical milestones and of the factors which influence drug development
• An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements
• Education in Pharmaceutical Medicine
• Experience from different organizations

Responsibilities

• Provides strategic medical and scientific knowledge (Cardiovascular, Renal, Metabolic, and/or Liver Disease) and supports the design, initiation, execution, completion, and interpretation of a clinical study
• Is accountable for study designs
• Is accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites
• Often works as a Global Clinical Head (GCH) delegate across several studies (e.g. a paediatric programme, or a set of mechanistic / differentiating studies)
• Can be the clinical representative on indication Global Product Teams and/or other sub-teams
• Has the knowledge to work across projects, with a fast learning curve when moving into new disease area
• Is accountable to the Global Clinical Head (GCH) or delegate for the medical aspects and designs of studies
• Is responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues in the study team
• Is accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP
• Is accountable for delivery of the clinical components of all relevant study documents (e.g Protocol, Amendments, Statistical Analysis Plan, Informed Consent Form, Case Report Forms, and Safety and Risk-Based Monitoring Plans)
• Is accountable for ensuring that safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting, the querying of missing/unclear data, the review of blinded safety data, and the escalation to the GCH/Global Safety Physician when needed.
• Is medically accountable for international investigator meetings, and supports Marketing Companies (MC) in national activities
• Approves (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion).
• Is accountable for ST induction and education of new members in the study team, as well as others involved in the study
• Collaborates seamlessly and efficiently with global colleagues at other R&D sites
• May be accountable to GCH (or delegate) and leadership for identifying risks and proposing mitigation strategies to deliver successful Phase II, III, IV or Life Cycle Management studies
• Stays updated on relevant scientific literature
• Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation
• Serves as a source of medical expertise for the Product Team, in analyses and interpretation of medical data
• Maintains a high degree of understanding and awareness on new and emerging medical development, globally.
• Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues
• Applies strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
• Able to provide guidance for investigator-initiated trials in cooperation with regional marketing companies
• Accountable for building trustworthy relationships with steering committees/executive committees with AROs/CROs
• Maintains strong networks globally with KEEs, prescribers, regulators and payers

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree