Job Title : Policy Director Gene / Cell Therapies (Hemoglobinopathies)
Department : Government Affairs and Public Policy
Reporting to the Head of Government Affairs and Public Policy (GAPP) in the International Region, the Policy Director will be responsible for developing and managing Public Policy initiatives in the International Region, monitoring, identifying and assessing policy risks and opportunities at national and local levels.
The Director of Policy will be responsible for working within the International HQ to assist the Head, Government Affairs and Public Policy in fully achieving the Department’s annual functional area goals in the areas of rare disease, ATMPs / ’curative’ therapies, gene editing, CRISPR / Cas9 : Hemoglobinopathies (β-thalassemia and sickle cell disease), regulatory and other related policy issues relating to this therapy area and assets.
This position will be required to represent Vertex effectively in numerous external forums, including formal and informal interactions with government officials, other industry representatives, trade associations and other key external stakeholders.
In addition, the position will also work with the regional and country teams as appropriate to ensure a consistent Vertex policy position across local policy and advocacy plans.
The successful candidate must work collaboratively with colleagues in other functions within the Company with including international patient engagement, communications, research, clinical development, regulatory affairs, medical affairs, commercial and health outcomes / market access.
The position must anticipate and develop policy changes that the company needs to address and pending and current opportunities and challenges that may impact the company’s therapeutic areas.
This position will proactively assess trends, policies and emerging issues and develop proposed strategies and content to effectively address issues that impact Vertex’s business.
The successful candidate will be based in London and will work closely with the Global Team, and selected country teams. Furthermore the candidate will collaborate very closely with the respective colleagues of CRISPR Therapeutics.
She / he will be responsible for projecting the highest values and ethics consistent with Vertex corporate policies at all times.
Key Responsibilities include :
Work closely with core teams, key functions, to identify and address public policy obstacles and opportunities to assist in achieving our local and regional objectives, including access, commercial, medical, and regulatory goals;
Proactively monitor, influence and shape relevant EU pharmaceutical, healthcare and regulatory policy in rare disease, gene editing, CRISPR / Cas9 : Hemoglobinopathies (β-thalassemia and sickle cell disease);
Drive Vertex International policy strategy and in partnership with relevant global and international colleagues develop core positions in support of Gene / Cell Therapies (Hemoglobinopathies) pipeline;
Produce and disseminate high quality policy research, analysis and written reports to support Vertex’s policy shaping priorities;
Elevate Vertex’s presence as a though leader in Gene / Cell Therapies (Hemoglobinopathies), by establishing, maintaining and growing Vertex’s relationships with academics, policy makers and industry peers;
Work with relevant functions to develop position papers and policy materials to support external advocacy campaigns;
Build coalitions with key stakeholders at EU level (Trade Associations, industry coalitions, NGOs, etc.);
Establish positions to take into EUCOPE, EuropaBio and other external industry discussions;
Input into advocacy plan towards the European and national institutions, working in close partnership with Director EU GAPP and Director international patient engagement for haemoglobinopathies;
Develop and execute EU Institutional advocacy and relations strategies to support Vertex regulatory strategies and affiliates in their market access policy issues;
Develop and leverage high-level relationships with academic groups, and stakeholders to achieve Vertex goals, bring value to patients and enhance the Company’s standing and reputation;
Work collaboratively with market access, regulatory, commercial, communications, patient engagement, and medical affairs teammates to ensure that the Policy efforts are aligned to meet company objectives and most effectively serve the needs of patients;
Provide international input and support to the development and resource prioritization for the Company’s global policy and market access strategy and plans;
Facilitate the sharing of best practices; coordinating global headquarter activities and leveraging for affiliates’ benefit where possible;
Develop comprehensive briefings to Senior Management on policy and legislative initiatives;
Brief business partners on changes and potential changes to relevant public policies that may directly impact our business strategy and plan;
Identifying and pursuing additional opportunities to advance our company’s business objectives;
Fulfilling other duties / projects as assigned;
Exemplifying Vertex’s core values in fulfilling these job duties.
Preferred Qualifications / skill set
Significant experience in Government Affairs / Public Policy / Public Health in pharma / biopharma on either the agency or corporate side;
Experience in Gene Therapies, Rare Diseases and Orphan Drug Market is highly desirable;
A high level of energy and passion towards patients, innovative science and public health;
A desire to work in the corporate culture of a highly innovative company aimed at redefining health, and transforming lives with new medicine;
Working knowledge and appreciation of the complexities of the drug development process and regulatory requirements;
Knowledge of the healthcare system and key policies relevant for pharmaceutical market access for highly innovative medicines;
Knowledge of the advocacy community / individuals in rare diseases preferred;
Strong track record of experience in piloting and implementing policy solutions with defined outcomes in a government affairs or policy role;
Experience in working across multiple departments in a global company;
Understanding of the global regulatory environment in which the Company operates;
High degrees of self-motivation and organization;
Excellent organizational skills, including the ability to use initiative, to prioritize workload, and work under pressure to achieve tight schedules and deadlines;
Ability to multi-task, deal with urgent, potentially high profile and unplanned requests for information and analysis at short notice;
Ability to work independently, jump into a fast-moving environment and absorb information quickly;
Problem-solving skills looks to actively manage problems and seek resolutions before they become issues. Presents solutions when a problem arises;
Strong interpersonal skills and integrity, and the ability to build relationships and establish credibility at all levels;
Comfort in a fast-moving environment with frequent changes in scope or direction of projects;
Excellent strategic thinker with ability to formulate, develop and execute on agreed strategies;
Successful working within cross-functional teams;
Excellent verbal, written, and interpersonal communications skills;
Experience with budget management;
Ability and willingness to travel;
Fluency in English, written and spoken and another language highly desirable