Job Summary

Leads drafting of development plans, protocol profiles, protocols, informed consent forms, and clinical sections of key submission documents. Oversees one or more clinical trials. Such trials could be pivotal for submission. Participates in creation of developmental and regulatory strategies and prepares clinical sections of regulatory documents; acts as the Point of Contact for interactions with regulatory agencies related to clinical matters. Represents Clinical Science in Project Team, possibly as the Clinical Science Lead; act as the subject matter expert to provide scientific direction to Clinical Operations and other functions.

Job Description

Responsibilities

Study Strategy:

• Leads drafting of development plans.
• Owns the development of study design to meet study objectives.
• Responsible for providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan.
• Develops biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP).
• With Data Management, co-leads the Integrated Data Review Plan process.
• In early-phase development, may lead clinical strategy development.

Study Planning and Execution:

• Provides input on major milestones of trial, clinical trial plan and contingency planning.
• Analyzes and updates management on potential risks to study deliverables.
• Leads study team in authoring of protocol and responsible for ICF creation.
• Consults and recruits members for DSMB and/or adjudication committee setup and develops supporting documents and charters.
• Leads development of protocol deviation management plan and contributes to monitoring protocol compliance to ensure proper identification and categorization of protocol deviations.
• Reviews patient population and protocol compliance for consistency with study strategy.
• Oversees recruitment and retention; establishes and implements contingency plans for shortfalls.
• Serve as the primary contact for both internal and external stakeholders.

Study outputs:

• Lead the review and discussions on emerging clinical data throughout the duration of the clinical trial, ensuring high-quality and timely execution of clinical deliverables and milestones.
• Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data;
• Works with BD&O to ensure SAP update.
• Leads dose-escalation meetings and other site facing interactions with Clinical Operations.
• Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements.
• Draft clinical sections of regulatory documents and responses to IRBs and Health Authorities. 

Responsibilities Continued

External collaboration:

• Leads interactions with with internal experts and external KOLs, Ad Boards for protocol development.
• Provides input on CRO / ARO Statement of Work and Budget; represents Clinical Science as the subject matter expert in study team meetings with CRO and ARO
• Establishes effective communication between CRO / vendors / ARO
• Meets with commercial group regarding new indications for Life Cycle Management. Scientific,

Program related:

• Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development strategy;
• Contributes to development of program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and react accordingly to new preclinical/clinical data(e.g.; Go/No Go decisions, reprioritization, etc.).
• Operational Project Team (OPT) leader; Responsible before the IST for the creation and execution of development strategy for a program.
• May potentially act as the Clinical Science functional representative on DAST. Leadership & non-study related activities: Occasional senior management interactions at FIHC, WDC.
• Initiates contact w/KOL and prepares material for KOL interactions to support program-based needs.
• Involvement with in-licensing and acquisitions on individual due diligence activities.
• Supports asset leader in creating a performance-based team culture with clear accountability and a sense of urgency for achieving results both directly and indirectly.
• Lead professionals in department specific knowledge, process and procedures.

Qualifications

Education Qualifications

• Bachelor's Degree life sciences or related field required
• Master's Degree, PharmD, PhD or equivalent preferred
• Postgraduate training in TA or related specialty, or equivalent preferred

Experience Qualifications

• 10+ years relevant clinical experience required
• Hematology experience preferred.
• Experience leading large, late-phase (Phase 2/3 or Phase 3) clinical studies.
• Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge. Ability to possess expertise and contribute to clinical trial strategy and execution cross-functionally required

Travel Requirements

Ability to travel up to 20% of the time.