Senior Medical Director/ Executive Medical Director Clinical Science, Oncology
Hengrui USA Princeton, NJ
- Posted: over a month ago
Reports to (Title): VP, Clinical Science-oncology & Deputy Head of development
Direct Reports : Yes
Department: Clinical Science
EEO Job Category Professional
Job Summary: Responsible for driving the US or global clinical development strategies and execution for assigned investigational and/or marketed products in the oncology Therapeutic Area (TA). The incumbent will be responsible for providing critical input into the strategy, development, management and implementation of Phase 1-4 clinical studies by closely working with the Clin Ops colleagues; providing US medical input to HQ Development teams on clinical development plan and LCM.
Essential Job Functions:
Clinical Development Expertise & Strategy
- Collaborate closely with relevant functions within HengRui Group, including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, as well as personnel from Global Clinical Operations, Global Strategic Marketing, and other support functions.
- Designs and develops clinical plans and protocols for assigned products with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
- Provides oversight and medical accountability for a group of studies
- Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists (CS)
- Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
- Identifies and builds relationships with principal investigators, key opinion leaders in drug development. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
- Maintains a strong medical/scientific reputation within the assigned disease areas. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorders. Holds strong expertise in the disease areas by attending scientific conferences and ongoing review of the literature
- Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
- Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
- Contributes to and is a key member of a high performing Study Delivery Team (SDT) and be a member of the Clinical Development Team (CDT)
- Leads medical data review of trial data, including eligibility review
- Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
- Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
- Leads collaboration with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
- Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Health Authority Interactions & Publications
- Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings
- Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with CSs
Experience / Education
- US board-certified or -eligible (or foreign-equivalent) MD is required; internal medicine and/or subspecialty training (preferred).
- At least 5 (director)/ 8 (Sr. Director) years of experience in US-based industry (Pharma/Biotech/CRO) including clinical development-related working experience in the oncology disease areas.
Knowledge / Skills / Abilities:
- Recognized expertise in clinical trials: working understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyze and author clinical trial publications; Thorough knowledge of the whole processes of clinical trials, clinical research concepts, practices, and GCP and ICH Guidelines
- Has working knowledge of GCP, ICH, US FDA and EMEA regulations, knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with the FDA is essential
- Proven success record in Phase I-IV clinical research studies, trial design, IND submission, and marketing approval-directed filings
- Proven ability to represent the Company's interests effectively in interactions with partners and regulatory agencies.
- Experience communicating and interacting with investigators, KOLs, and advisors
- Experience working with the principles and techniques of data analysis, interpretation and clinical relevance
- Proven ability to "build a case," both with internal scientific management and the Company's partners / collaborators.
- Ability to lead a dynamic group in a fast-paced and hands-on environment.
- Must have strong consensus-building skills and the ability to lead multi-disciplinary teams towards sound decision-making.
- Ability to develop and implement strategic growth plans.
- Ability to work collaboratively with cross-functional team to support management of large volumes of data
- Ability to operate and thrive in a fast-paced environment; demonstrated flexibility
- Demonstrated success of taking initiative in a team setting
- Comfortable with ambiguity, yet be self-motivated and timeline driven
- Prior leadership experience is required, prior managerial experience is preferred
- Ability to travel up to 20% as needed
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
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