Position Details

• Designation: Vice President – Head of Program Development & Regulatory Affairs
• Business Unit: Clinical Development
• Location: NY
• Reporting to: Chief Medical Officer
• Travel - 25%
   

Role Overview / Purpose

The Vice President–head of Program Development (PD) & Regulatory Affairs (RA) will report to the Chief Medical Officer and will provide leadership to a cross-functional Clinical Development (CD) team for programs in the IND stage and/or in the clinical stage (Ph1 or late stage of development). This role will serve as PD Team Lead for assigned programs for 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. Program Management and Regulatory Affairs will report to this role and may take additional line reports if needed.

Job Responsibilities

• Lead the cross-functional Program Development Team strategy and execution for IND or clinical-stage oncology programs and report to the CMO progress and challenges
• Constructs and updates asset development plans through IND to BLA approval by leading cross-functional efforts to evaluate available data, competitive landscape, opportunity, regulatory precedence, and clinical study designs that deliver value in collaboration with CMO or program medical lead
• Supervise the company's global regulatory activities and global PM across all stages (except CMC) of development, for all programs, both pre-clinical and clinical.
• Ensure 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 PD Team 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 and governance meetings for assigned programs, updates, and communications to CMO, as well as governance and leadership teams, as requested. 
• This role will report to the CMO and will be part of Development LT, Monthly Operating Review Meeting (MOR) and Research and Development LT (RDLT). Ensures successful implementation of clinical supplies strategy.
•  Accountable for the overall budget and project plan deliverables.
•  Supports business development and out-licensing for assigned programs, as
• as applicable. 
• May take responsibility for more than one program in different stages 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.
•  Supports CMO in department-related activities and initiatives (preparation of f2f meetings, department objectives, process and other improvement initiatives for different function, etc)
•  Builds and maintains Clinical Development 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.