Vice President, Product Development
2 months ago
Vice President, Product Development
Job Purpose
The Vice President of Product Development is a critical leadership role, responsible for shaping the product development strategy across all stages, from early phases to commercialization. This role will provide strategic direction for CMC development activities internally and external partners, including Active Pharmaceutical Ingredients selection, formulation development, manufacturing, packaging, and analytical processes. Collaborating with cross-functional teams, such as Regulatory Affairs, Quality, Clinical, Medical Affairs, Manufacturing Science & Technology, and Project Management, this leader will ensure a strategic and compliant drug development program. Additionally, the VP oversees proof-of-concept formulation strategies, quality by design, and analytical processes. The role will extend to supporting quality, regulatory filings, technology transfer, and will contribute to Ironshore's ongoing research and development efforts and driving successful commercialization.
Essential Duties & Responsibilities
Product Development / Portfolio Expansion
Participate in the preparation of strategic plans for development of new assets or expansion into new therapeutic areas from proof of concept to Phase 3.
Develop robust experiments and data packages to support submission strategy and product approval.
Provide scientific and technical leadership to Ironshore as well as Contract Manufacturing Organization (CMO) project teams.
Use technical expertise and management experience to resource programs appropriately, set project priorities, resolve technical challenges.
Develop budgets that align with the development program and R&D objectives.
Carry out appropriate risk mitigation throughout the product development life cycle.
Develop communication plans for project teams and executive updates.
Analytical Activity Management
Provide scientific and technical leadership to Ironshore as well as CMO project teams related to analytical development, results evaluation, priority setting and ensuring appropriate resources.
Use technical and management experience to guide design of analytical experiments, resolve technical challenges, collaborate with CMO's and ensure progression of activities to appropriate standards.
Oversee analytical method development and phase appropriate validation activities of drug substances and drug products for each program, as well as method transfers to/from CMO's.
Provide guidance and supporting data for the establishment of scientifically justifiable specification and control strategies.
Work closely with Regulatory, Quality, Operations and Clinical regarding testing and stability requirements to support product development, process development and clinical supply.
Formulation Activity Management
Provide scientific and technical leadership to Ironshore as well as CMO project teams related to formulation development, process evaluation, priority setting and ensuring appropriate resources.
Use technical and management experience to guide design of experiments for formulation development for proof of concept, process development/optimization, all phases to validation.
Resolve technical challenges, collaborate with CMOs and ensure progression of activities to appropriate standards.
Support raw material and API evaluation and selection.
Develop budgets for manufacturing activities.
Provide strategic direction for continuous improvement activities and required re-validation.
Work closely with Regulatory, Quality, Operations and Clinical regarding manufacture and clinical supply.
Contract Manufacturing Organizations
Involved in selection and evaluation of contract manufacturing organizations for manufacturing, packaging and analytical requirements as required for the specific development program.
Build strong relationships with partners and manage conflicts through successful communication and risk mitigation strategies.
Provide oversight of activities at CMO's virtually or through on-site visits.
Serve as subject matter expert for audits of CMO's and root cause analysis.
Review and interpret results, as well provide technical input into any deviations or atypical results observed to ensure the conduct of an appropriate investigation and resolution of the issue.
Regulatory Submissions
Participate in development of regulatory strategy, content, experiments, and timelines.
Author or review specific CMC sections within a regulatory dossier (IND, NDA, CTAs), technical reports (analytical, development, etc.) to support regulatory submissions and/or meeting technical packages and for any information requests from a Regulatory Agency.
Review of stability data to Ensure submission ready state stability data, including graphs, trending, and statistical analysis, is available as per submission timelines.
Education, Skills & Experience
Education
MSc, PhD or PharmD required in scientific-related field. Equivalent work experience will be considered.
Knowledge/Skills
Innovative and extensive technical expertise in drug development, with broad technical knowledge in small molecule, delivery platform technologies and knowledge of early and late phase development requirements.
Forward-thinking strategic leader with experience in product planning.
Working knowledge and insight into applicable regulatory environment.
Experience
Minimum 12+ years of relevant experience in the pharmaceutical industry, with a strong background in formulation development, process development/optimization, and analytical for all phases of development up to and including commercialization.
Demonstrated success in leading a development program from inception through to regulatory approval, including direct experience with authoring submissions such as sNDA (Supplemental New Drug Application), ANDA (Abbreviated New Drug Application), NDS (New Drug Submission), and BLA (Biologics License Application), etc.
Demonstrated experience in leading/engaging others in a direct and highly matrixed, fast growing global health care organization.
Proven track record of leading and managing a multidisciplinary team, and effectively guiding, coaching and developing internal talent.
Proven ability to work in and deliver in a fast-paced environment where multiple development projects are in process with multiple CMO's and aggressive timelines.
Extensive experience at establishing and building working relationships with external CMOs to drive success.
Equal Employment Opportunity
Ironshore is committed to fostering an inclusive and diverse workplace. We believe that every individual deserves equal opportunities regardless of their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Our company values diversity and strives to create an environment where everyone feels respected, valued, and empowered. We encourage all qualified candidates to apply for our open positions. Ironshore Pharmaceuticals is an equal opportunity employer and prohibits discrimination based on any protected characteristic. We comply with all applicable federal, state, and local laws regarding EEO and affirmative action.
Accessibility and Reasonable Accommodations:
If you require a reasonable accommodation for any aspect of the application process or to carry out the essential duties of a position because of a medical condition or disability, please reach out to our HR team and provide the nature of your request, your contact information, and the job title and requisition number.
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