Designation: Program Development Team Lead Oncology, Executive Director
Business Unit: Clinical Development
Location: NYC, HQ
Reporting to: Chief Medical Officer
Travel: 25%

Role Overview / Purpose

The Program Development Team Lead (PDTL) provides leadership to a cross-functional Clinical Development (CD) team for a ph1 program transitioning into late development. PDTL leads the development strategy, decisions and execution of trials and program deliverables. Further, the PDTL champions the programs at all levels of IGI and is responsible for managing the alignment of communication, priorities, and budget on all PDT matters, as appropriate.

Job Responsibilities

• Lead the cross-functional Program Development Team (PDT) strategy and execution for the ph1 oncology program transitioning into late-stage development.
• Constructs and updates asset development plans through ph1 to BLA approval by leading cross-functional efforts to evaluate available data, competitive landscape, opportunity, regulatory precedence, and clinical study designs that deliver value.
• Ensures successful progress of clinical trial deliverables by cross-functional team (operational site opening and performance; clinical, translational, and PK data review and analysis; regulatory documents; protocol amendments; study reports; publications; scientific advisory board deliverables).
• Challenges all functions on PDT to ensure that all issues and questions are being addressed, and that line function input into strategy and plans is adequate to meet the needs of the program. When necessary, negotiates with function heads on functional deliverables.
• Identifies potential issues and leads contingency planning; leads PDT problem-solving and applies decision-making tools and techniques. Drives PDT to make effective and efficient decisions.
• Lead presentation and discussion for all Stage Gate decisions, updates, and communications to governance and leadership teams
• Ensures successful implementation of clinical supplies strategy.
• Accountable for the overall budget and project plan deliverables.
• Supports business development and out licensing for assigned program, as appropriate
• May take responsibly of more than one programs in different stage of development, as applicable.
• Major collaborator with Alliance partners and aligns global strategy within a partnership, as applicable
• Leads the communication of strategy, issues, and plans to the PDT, alliance partners, and other key stakeholders.
• Builds and maintains team effectiveness and satisfaction.
• Drives innovation by benchmarking

Desired Experience and Knowledge
Educational Qualifications

Candidate is preferred to hold advanced degrees such as PharmD, Ph.D., Master or MD.

Experience

• Minimum of 8-10 years’ experience part of a research-driven biotech and or pharmaceutical company
• Minimum of 5 years experience in oncology drug development. Knowledge of myeloma or hematological malignancies is a plus
• Experience in leading clinical cross-functional oncology drug development teams with working knowledge across multiple R&D functions (preclinical, clinical, regulatory, CMC, medical affairs)
• Late-stage clinical development through BLA/IND submission and approval experience
• Solid business acumen and understanding of financial concepts
• Strategic agility: ability to pivot a team based on emerging and/or incomplete data, business drivers, or competitive landscape
• Independent ability to manage ambiguity and to translate the big picture into specific short- and long-term deliverables
• Demonstrated ability to influence and negotiate across the organization without direct reporting authority
• Outstanding communication skills

Behavioral Attributes

• Excellent verbal and written communication skills. Team member who can work collaboratively and extremely well with colleagues across all functions and levels
• Demonstrated ability to think strategically and operationalize scientific ideas and clinical visions successfully.
• A strong track record of producing results in a matrix-based environment is essential. Always maintain a positive & professional self-representation & on behalf of the company to external and internal partners