Lediga jobb Egetis Therapeutics AB (publ) i Stockholm

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!

Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. For the lead drug candidate, Egetis submitted a marketing authorization application to the European Medicines Agency (EMA) in October 2023 and intends to submit a new drug application (NDA) in the US in mid 2024 under the Fast-Track Designation granted by FDA. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.

We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!

We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible if you prefer to work from home anywhere in Europe or East Coast North America.

As the Regulatory Affairs Manager you will be a member of the regulatory team, as well as representing Regulatory Affairs in cross-functional teams. You will support and lead activities such as planning for health authority interactions and submissions. In addition, you will work closely with the VP regulatory affairs, and team, in overseeing external regulatory vendors. You will lead the regulatory operational aspects and be a part of regulatory compliance and submissions for all projects across the company.

• Responsible for establishing regulatory planning and tracking tools to ensure regulatory submission strategies are delivered in alignment with business needs.
• Responsible for planning and managing regulatory submissions and support interactions with Health Authorities including scientific advisory meetings.
• Coordinate the preparation, submission, responses to requests from regulatory agencies and follow-up contact with regulatory agencies for all applications and submissions.
• Supporting regulatory compliance to be aligned with regulatory requirements and regulations.
• Responsible for providing regulatory support to business development, including management of due diligence activities.
• Support the Regulatory team and cross-functional teams in the global Managed Access Program.
• Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise the Reg Affairs organization and project team accordingly.
• As an Egetis Therapeutics member of the Regulatory Team, contribute to the overall development of the company and value creation.

Your background

Education

• A Bachelor of Science degree or Master of Science (Biology, Pharmacy, Chemistry)

Experience

• Experience from Regulatory Affairs in biotech and pharmaceutical industry, Rare disease drug development program experience is a big plus.
• Experience of HA submissions in early and late development, supporting successful Phase I-III clinical trials submissions including INDs, CTAs (CTIS).
• Global Experience of coordinating marketing authorisation applications is a big plus
• Experience of regulatory management of expanded access programs is a plus.
• Experience of electronic submission requirements and publishing.

Your Skills and Abilities

Skills and Abilities

• Balancing stakeholders; Anticipating and balancing the needs of multiple stakeholders.
• Action oriented; Taking on new opportunities and tough challenges with a sense of urgency.
• Plan and align: Planning and prioritizing work to meet commitments aligned with organizational goals.
• Communicate effectively
• Manage ambiguity; Operating effectively, even when things are not certain or the way forward is not clear.
• Being resilient; Adapting approach and demeanor in real time to match the shifting demands of different situations.
• Ability to foresee long-term consequences of decisions.

Values

Naturally you share our values:

• Courage - We challenge the status quo for the benefit of the patient
• Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results
• Collaboration – Through trust, we work seamlessly across functions and with external partners Visa mindre

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!

Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.

We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!

Duties and Responsibilities

As Global Head Biostatistics, you are responsible for the strategic and operational statistical leadership

• Accountable for developing statistical strategies for drug projects in development and commercial phase.
• Accountable for planning and leading activities, employees, and consultants in the areas of data management, programming, and statistics.
• Accountable for delivery of the statistical contributions to regulatory marketing applications and interactions with Health Authorities including scientific advisory meetings and responses to requests from regulatory agencies
• Accountable for providing statistical guidance to support business development, including due diligence for potential in-licensing, external collaborations, and acquisitions
• Accountable for delivery of statistical activities in clinical development, including e.g

• • statistical design of clinical studies and sample size calculations
• • statistical analysis plans
• • programming of study databases, e.g. SDTM and ADaM
• • quantitative monitoring of ongoing clinical studies
• • statistical analysis and interpretation of study results
• • statistical modelling
• • randomization and electronic data capture system set-up and eCRF design

You will report to our VP Product Strategy and Development.

We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible if you prefer to work from home anywhere in the world.

Your Background

Extensive experience in Biostatistics during drug development including leading positions (minimum 15 years)

Scientific background: MSc, PhD or equivalent

Global leader role experience in internal, as well as external, collaborations.

Competencies

Manage Complexity: Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.

Make sound decisions: Make good and timely decisions that keep the organization moving forward.

Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy and enthusiasm.

Direct Work: Providing direction, delegating and removing obstacles to get work done.

Plan and align: Planning and prioritizing work to meet commitments aligned with organizational goals.

Ensure Accountability: Holding self and others accountable to meet commitments.

Manage Ambiguity: Operating effectively, even when things are not certain or the way forward is not clear.

Values

Naturally you share our values:

Courage - We challenge the status quo for the benefit of the patient

Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results

Collaboration – Through trust, we work seamlessly across functions and with external partners Visa mindre

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!

Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. For the lead drug candidate, Egetis submitted a marketing authorization application to the European Medicines Agency (EMA) in October 2023 and intends to submit a new drug application (NDA) in the US in mid 2024 under the Fast-Track Designation granted by FDA. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.

We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!

As a Data Science Lead, you are responsible for data deliveries within projects, including collection, validation, transfer, programming, analyses, reporting and interpretation of data.

You will assist with operational data strategies for drug projects in development and commercial phase, within cross-functional teams (e.g. clinical studies, regulatory submissions, health technology assessments and publications).

The work involves planning and oversight of deliverables outsourced to vendors in the areas of data management, programming, and analyses, as well as hands-on work. You will also assist with regulatory submissions and responses to requests from regulatory agencies.

You will report to our Head of Biostatistics.

We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible if you prefer to work from home in Europe or North America.

Your Background:

• Experience from Data Science during late-stage drug development (Clinical Data Management, Programming, Analysis, Reporting)
• Minimum 5 years’ experience from pharmaceutical industry
• Relevant scientific background: BSc, MSc or similar
• Experience from internal, as well as external, cross-functional collaborations

Your Competencies:

• Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy and enthusiasm.
• Optimizes Work Processes: Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Drives Results: Consistently achieving results, even under tough circumstances.
• Interpersonal Savvy: Relating openly and comfortably with diverse groups of people.
• Self-Development: Actively seeking new ways to grow and be challenged using both formal and informal development channels.
• Manage Ambiguity: Operating effectively, even when things are not certain or the way forward is not clear.

Naturally, you share our Values:

• Courage: We challenge the status quo for the benefit of the patient
• Commitment: We operate with high ethical standards through an efficient organization to deliver top quality results
• Collaboration: Through trust, we work seamlessly across functions and with external partners Visa mindre

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!

Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.

We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!

Brief description of the position

The Clinical Trial Assistant role is responsible for supporting the clinical team in all activities from set up to completion of clinical studies and projects as directed. May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation including CRO study trial master file oversight activities. Perform administrative tasks to support team members with clinical trial execution as directed, and general “day-to-day” administrative tasks to support clinical team members.

The role is a full time position, based in our centrally located office in Stockholm. We are also open to discussing part time solutions.

Responsibilities

• To assist the Clinical Development teams in completion of all required tasks to meet departmental and project goals and support in ongoing conduct of studies.
• To assist project teams with study specific documentation and guidelines as appropriate.
• To set up, organize and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival.
• To assist in quality control of clinical study documentation.
• Ensure accuracy, quality and integrity of internal and clinical study documentation and adherence to record retention policies and regulations.
• Maintain central registry of contact information for clinical sites, CROs, vendors and support and facilitate correspondence
• Contribute to departmental development and review of study standard operating procedures (SOPs)
• Assist in coordination of CRO and Vendor payments, tracking of payments and accruals, if applicable.
• Arrange/support internal/external meetings relating to clinical study activities, such as kick-off meetings with vendors, clinical expert meetings and investigator meetings
• Provide clerical support and administrative activities for project team (e.g., proofreading and editing correspondence).
• Coordinate document translation through vendors.
• To assist in the production of slides, etc., as needed for project, departmental, sponsor and/or business development presentations.
• Responsible for filing and tracking of Consultancy contracts
• Other administrative duties as assigned by Head of Clinical Development or CMO

You report to the Head of Clinical Development. This position has no direct reports.

Competence requirements for the position (education and experience)

• Required education: Certification in an allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or long-term experience as a CTA
• Experience in clinical research area
• Experience with document management systems and quality review of documents
• Knowledge of clinical terminology required
• Must have good organization skills, comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Be a team player
• Highly organized and process oriented
• Understanding of ICH GCP and appropriate regulations
• Good written and verbal communication skills.
• Fluency in local language and good knowledge of English language.
• Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook Visa mindre

Our Head Quarter is based in Stockholm. For this role, you may work remotely from anywhere in Europe.
As Global Head Medical Affairs, you will provide strategic planning and leadership in execution of all global Medical Affairs activities that advance the understanding and shape the medical landscape in relation to the relevant diseases and Egetis Therapeutics products. You will oversee and drive the performance and development of the global medical affairs team. As a key member of the global commercial leadership team, you will contribute actively to the overall global strategy. You will be the owner of the global medical affairs plans and take an active role in the implementation of key activities. Being the chairman of the Global Medical Affairs Team meetings, you will coordinate activities and facilitate sharing of market insights and best practices. The role reports to the Chief Medical Officer and has a dotted line to VP Commercial Operations.
Duties and responsibilities
Accountable for development and implementation of product specific global medical affairs plans and alignment across countries, in line with best clinical practices and overall Commercial/Corporate objectives
Accountable for interactions with patient advocacy groups
Ensure all Medical Affairs activities comply with current pharmaceutical regulations, Egetis Therapeutics’ internal policies and procedures, Egetis Therapeutics’ Code of Conduct and follows state of the art governance, reporting systems and structures
Support managed access initiatives for Egetis Therapeutics’ drug candidates ahead of marketing authorization
Ensure scientific leadership in the relevant diseases
Develop and continuously maintain the highest product and scientific/medical expertise of all Medical Affairs employees, ensuring they are acknowledged internally and externally as experts
Systematically assess medical education needs cross-functionally and implement appropriate medical education programs for commercial teams and other functions
Engage in planning and execution of advisory boards, symposiums and congress activities
Engage and build sustainable relationships with external stakeholders as a key ambassador of the company
Contribute to development of life cycle management plans
Contribute to market access activities such as value dossiers
Contribute to global publication planning
Develop data dissemination strategies
Contribute to medical information activities
Attract, develop and retain talents
Exemplary role model of our Values
Craft a culture that encourages others to be their best and speak up
Ensure field-based medical teams have clear objectives, performance metrics and collaborative and compliant working relationships with other functions

What you will bring to the role:
Experience and Education
You have an MD, if you have a PhD it is a plus
Significant (10+ years) experience in a biotech or pharmaceutical company, with increasing levels of leadership responsibility within R&D and/or Medical Affairs
Prior launch experience required
3+ years experience from medical affairs roles in rare diseases
Demonstrated success in small, entrepreneurial environment through a hands-on, solution-oriented approach
Previous experience from endocrinology or neurology therapeutic areas is a plus

Competencies
As a leader you have customer focus, a strategic mindset and can manage complexity. You drive results and engagement, work collaboratively with others and know how to build effective teams. You can also adapt your approach to match the shifting demands of different situations
You are fluent in English, both written and verbal, and have strong presentation skills
You also bring deep knowledge of current pharmaceutical regulation and proven ability to manage budgets and resources

Values
Naturally you share our values:
Courage - We challenge the status quo for the benefit of the patient
Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results
Collaboration – Through trust, we work seamlessly across functions and with external partners Visa mindre

Our Head Quarter is based in Stockholm. For this role, you may work remotely from anywhere in Europe.
As Global Head Market Access and Pricing, you are accountable for the development and execution of successful P&R strategies to maximize value throughout the lifecycle for Egetis Therapeutics’ drug candidates and products. Specifically, you lead efforts in assessing the MA&P opportunities for pipeline products and communicating market access matters to internal and external stakeholders, shaping and implementing the overall value strategy for indications and products throughout their lifecycles. You support Egetis Therapeutics’ country teams in the preparation and delivery of P&R negotiations and are responsible for helping translate relevant developments into meaningful guidance and strategic advice. As a key member of the global commercial leadership team, you contribute actively to the development and execution of global product strategies. The role reports to the VP Commercial Operations.
Duties and responsibilities
Accountable for the development and execution of successful P&R strategies for Egetis Therapeutics’ products and drug candidates to maximize value throughout the lifecycle
Accountable for identifying and driving critical HEOR, meeting international requirements and consider localization and adaptation plans in collaboration with country teams
Accountable for development of value dossiers and supportive data (e.g. burden of disease studies)
Lead the International Value & Access team
Lead the development and implementation of optimal P&R strategies for Egetis Therapeutics’ portfolio in international markets in collaboration with General Managers and regional Market Access Leads
Analyze, synthesize, and translate technical P&R information, including coverage and reimbursement policies, into meaningful decision points, recommendations and strategic tactics
Oversee creation and delivery of country specific P&R dossiers working in close partnership with General Managers and regional Market Access Leads
Champion the P&R requirements and ensure alignment between all stakeholders internally as to prioritized needs
Provide leadership and manage multiple strategic projects, while maintaining an understanding of national, regional and global perspectives and objectives
Provide strategic input to strategy discussions and communication efforts, with relevant external stakeholders including key government agencies and organizations
Communicate and partner directly with cross-functional colleagues and external agencies
Support due diligence efforts by leveraging P&R expertise to inform commercial assessments of potential in-licensing/acquisition targets from an international perspective
Actively partner cross-functionally for developing compelling value communications
Coordinate and oversee projects with external consultants as needed
Attract, develop and retain talent
Exemplary role model of our Values
Craft a culture that encourages others to be their best and speak up
Communicate frequently and effectively partner with stakeholders/team members throughout the organization
Produce well-written Word documents, PowerPoint presentations, and Excel spreadsheets that communicate key points in a crisp and concise format

What you will bring to the role:
Experience and Education
A BA or BSc is required; a graduate degree (MSc or MBA) is strongly preferred
7+years of Market Access experience, whereof at least 3 years in rare diseases
Previous experience from endocrinology or neurology therapeutic areas is a plus
Market access experience in international, multi-lingual, and cross-cultural pharmaceutical/biotech industry
Experience in organizing and prioritizing an international workload, ideally through MA&P responsibility for orphan drug
Proven ability to manage budgets and resources
Demonstrated success in small, entrepreneurial environment through a hands-on, solution-oriented approach

Competencies
As a leader you have customer focus, business insight, a strategic mindset and can manage complexity. You drive results and engagement, as well as work collaboratively with others. You can also adapt your approach to match the shifting demands of different situations.
You communicate effectively in English, both in writing and verbally. Any other language would be an asset.
You have an open mind about new ways to approach P&R issues, particularly related to rare diseases
You also bring excellent computer skills (Excel, PowerPoint, Word)

Values
Naturally you share our values:
Courage - We challenge the status quo for the benefit of the patient
Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results
Collaboration – Through trust, we work seamlessly across functions and with external partners Visa mindre