VP Head of Oncology GRA

Location
Cambridge, MA, United States
Posted
Jul 21, 2019
Ref
R-01684
Discipline
Science/R&D, Oncology
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Full time
The VP & Head of Global Regulatory Affairs, Oncology will be accountable for the development, flawless execution and implementation of global regulatory strategic activities related to the oncology portfolio, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products.
  • Be the oncology strategist and expert.
  • Develop and implement pro-active regulatory strategies for the US, EU and Asia-Pacific markets.
  • Coordinate with Global Regulatory Therapeutic Heads for the other therapy areas as required.
  • Be a key leader for the GRA through membership of the GRA Leadership Team.


Responsibilities

Responsibilities will include, but are not limited to, the following:
  • Accountable for the development and continuous adaptation of the regulatory strategies for all oncology products/projects.
  • Work closely in alignment with other Global Therapeutic Area Heads in GRA.
  • Ensure regulatory input into target product profiles (target indications, therapeutic positioning, and key differentiating characteristics).
  • Ensure regulatory input into the Integrated Development Plans. In collaboration with other Research & Development departments, define the optimal plan to reach the target product profile, taking into consideration the most favorable timing for key markets.
  • Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Franchises, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; proposes remediation where possible.
  • With R&D, Franchises, Operations and Project Teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes. Identify opportunities and limiting factors for optimal label and propose alternative solutions.
  • Incorporate commercialization challenges into regulatory strategy in term of data collection into pivotal studies to match the payer's requirements and shorten time to market (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond
  • Marketing Authorization, to incorporate relevant Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics.
  • With Franchises, contribute to the definition of the appropriate strategy for the assigned portfolio.
  • Consider regulatory avenues to maximize intellectual property protection and data exclusivity.
  • Ensure collaboration of the assigned portfolio regulatory teams with other GMRS functions in the establishment of CCDS and required safety plans.
  • Ensure regional regulatory specificities and needs are incorporated into the global plans.
  • Define strategy around regulatory consultation and means (e.g. Scientific Advice, EMA, FDA planned meetings, regulatory boards).
  • In collaboration with R&D, Franchises, Operations, Project Teams and other members of the GRA leadership team, define regulatory priorities globally.
  • As a member of the GRA LT, accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes.
  • Regulatory Intelligence: continuously monitors the scientific evolution of the therapeutic areas for its regulatory impact; incorporates external environment into plans.
  • Help recruit, train, develop and retain via matrix management lead a team of regulatory professionals dedicated to the provision and implementation of regulatory strategies.
  • Ensures timely and accurate communication of information of regulatory developments to all stakeholders (Management, governance committees, development and commercialization teams, Public Affairs, Legal, Investor Relations, etc.).
  • Assure a flawless transition with the SVP Global Regulatory Affairs who is the "ad interim" Global Head of Oncology.
  • Acquire full knowledge of the Ipsen portfolio.
  • Develop strong partnership with the Global Head of Oncology clinical development.
  • Take full accountability of the development of regulatory strategies for new compound and life cycle management of the current portfolio.
  • Develop partnership with Oncology franchise head and the Market access management team.
  • Lead by example and share equally the time between strategies development and operational improvement.


Qualifications

Education
  • Master's degree in scientific discipline (Pharmacy, Medicine, or Biological Sciences). Advanced degree is a differentiator.


Experience
  • At least 12 years professional experience in the pharmaceutical industry, including a minimum of 10 years in Regulatory Affairs.
  • Current experience in the Oncology therapeutic category is essential. Experience of superior leadership credentials and experience of this category in the recent past will also be considered.
  • Experience of developing regulatory strategies for niche products is desirable. Knowledge in radiopharmaceuticals would be appreciated.
  • Relevant experience on global development with both EMA and FDA strong relationship is required.
  • Multi international project coordination within the GRA support team and capability to prioritize efficiently the workload assigned to the team is required.


Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)
  • Leadership - demonstrates strong leadership with ability to influence without authority. Possesses a high degree of credibility by gaining trust and confidence of others.
  • Strategic Agility - proactive, forward thinker with a creative and solutions-mindset, sees ahead clearly, able to think innovatively about regulatory strategy, can anticipate future consequences and trends accurately, has broad knowledge and perspective; is future-oriented, can articulately paint a credible picture and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.
  • Interpersonal Skills - relates well to all kinds of individuals, listens, builds effective relationships, uses diplomacy and tact, values people and can diffuse high tension situations comfortably; strong influencing skills.
  • Quality - Provides the highest quality of regulatory strategy and operations through continuous improvement and empowerment; creates a learning environment leading to the most efficient and effective work processes.
  • Communications - Excellent written and oral communication skills; ability to distil key information from complex and extensive sources and present the information in a positive way.


IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.