Senior Director, Global Clinical Development Scientist

AstraZeneca•Cambridge, MA

6d•$233,586 - $350,380•Hybrid

About The Position

The Senior Director, Global Clinical Development Scientist is the clinical science driver for pivotal, late-phase global oncology studies, translating program strategy into study plans and interpreting evidence to support patient care, clinical practice, regulatory decisions, and investment and approval recommendations. The role partners closely with a physician counterpart and cross-functional teams from study concept through delivery and registration, influencing protocol integrity, recruitment, and high-stakes Go/No-Go decisions. The position is flexible to be based in Gaithersburg, Maryland; Barcelona; or Mississauga. The company expects employees to work from the office an average of at least three days per week, while allowing individual flexibility. The role develops and owns clinical study documents and protocols, supports study delivery and recruitment, and may lead study-level medical monitoring and safety reviews. It leads clinical data interpretation and clinical study report development, supports health authority interactions and registration submissions, and works with investigators and internal partners on study feasibility, training, and recruitment. It also represents Clinical Development on global study teams, contributes to process improvement, and mentors or may manage less experienced team members. The annual base salary range is $233,586.40–$350,379.60 USD. The position is eligible for short-term incentive bonuses and equity-based awards for salaried roles. Benefits include qualified retirement programs, paid time off (including vacation, holidays, and leaves), and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

At least 7 years of industry or academic experience in drug development.
Sound foundational knowledge of FDA and other major-country regulations.
Detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
General knowledge of medical monitoring, regulatory approval processes in relevant countries, pharmaceutical industry and R&D operations, and marketing and commercial fundamentals.
Significant oncology therapeutic experience, with the ability to serve as a resource for internal or external colleagues.

Nice To Haves

PharmD, Ph.D. in life sciences, or MD; these qualifications are preferred.
Oncology experience; strong preference stated.
Ability to independently lead components of complex clinical development plans, related documents, methodologies, analysis plans, and evaluation tools.
Experience driving protocol design, writing, and implementation to meet GCP, ICH, and internal quality standards.
Experience with state-of-the-art clinical research methodologies, including novel endpoints, biomarkers, adaptive or innovative trial designs, and advanced analytical approaches.
Strong communication and presentation skills for internal governance committees and external audiences, including investigator meetings, IDMCs, and scientific conferences.
Experience contributing to and leading clinical reports and integrated summaries for complex global projects.
Experience leading study-level medical monitoring and safety reviews.
Success working in global, matrixed teams across multiple countries and time zones.
Track record of mentoring or managing clinical staff and shaping team performance.
Ability to influence and build consensus across operations, biostatistics, regulatory, safety, and commercial stakeholders.
Advanced oncology therapeutic-area expertise across multiple tumor types.

Responsibilities

Translate program strategy into study concept documents, protocols, informed consent forms, case report forms, tables/listings/figures shells, and related materials, aligned with clinical practice, scientific and regulatory developments, and program objectives.
Own the scientific rationale and clinical integrity of protocols and clinical plan components; deliver final protocols and secure governance approvals in partnership with the Study Physician, GCPL, and GCH, including technical reviews at bodies such as DRC and PRC.
As appropriate, lead and approve the Medical Oversight Plan.
Drive timely study initiation and execution with Clinical Operations, Program Management, GSTs, SMM, supply chain, and sample management.
Identify recruitment risks, propose and support mitigations, provide clinical input to feasibility questionnaires, consult on country and site selection, and respond to site queries and EC/IRB requests.
As appropriate, lead study-level medical monitoring and safety reviews to protect participants and data quality.
Lead high-level clinical data reviews and interpretation, develop content for governance Go/No-Go decisions, and lead development and delivery of the clinical study report.
Support health authority interactions; contribute clinical components to regulatory and EC/IRB submissions and clinical input to registration packages such as NDA/BLA submissions.
Collaborate on launch and branding materials and publications.
Work with investigators, KEEs, MSLs, and SMMs to optimize study design, feasibility, and recruitment; contribute to advisory boards and develop and deliver investigator and monitor training.
Serve as a core GST member representing Clinical Development and incorporate cross-functional input from global medical affairs, marketing companies, commercial teams, and other stakeholders.
Provide expert input to or lead process improvements, contribute to cross-asset or cross-tumor working groups, and mentor and develop less experienced team members; provide line management as appropriate.