Medical Program Director Haemophilia
Great opportunity for you who have experience in clinical development and clinical studies to join SOBI.
Your new company
Sobi is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the lives of rare disease patients and their families. Our research and product portfolio is primarily focused on haemophilia, inflammation and genetic and metabolic diseases. We market and make available across Europe, the Middle East, North Africa and Russia a portfolio of specialty and rare disease products for partner companies. We have world-class capabilities in protein biochemistry and biologics manufacturing development - validated by leading industry partners. We manufacture the drug substance for the haemophilia treatment ReFacto AF/Xyntha® for the global market. Our organisation spans 24 countries, delivering therapies to patients in 67 countries across the globe. The Sobi share is listed on NASDAQ OMX Stockholm (STO:SOBI). In 2016 revenues were 5.2 bSEK and we employed 760 employees.
Your new role
Sobi has an exciting and expanding portfolio, which is being developed both alone and in collaboration with a number of strategic partners. The R&D organisation comprises around 140 staff across Clinical Development, R&D Operations, Research & Translational Science, Project & Portfolio Management, Regulatory Affairs & Drug Safety. Clinical Development is a strategically important function within the R&D organisation, and Sobi is now looking to recruit an outstanding medically-qualified individual to become Medical Program Director within haemophilia reporting to the Head of Clinical Development. Clinical Development comprises 35 employees (including consultants) covering Medical Program Directors, Clinical Pharmacology & Translational Medicine, Clinical Operations, Data-Management, Statistics and Clinical Reporting. The department is responsible for all Clinical Development activities, including Life Cycle management.
Key Responsibilities/Scope of the Job
Including but not limited to the following
- Overall medical responsibility in appointed clinical projects
- Responsible for IB’s, protocols and reports from a medical legal perspective
- Responsible for medical parts in regulatory documents
- Ensure an appropriate and continuous medical risk/benefit assessment
- Execute a risk minimization at all stages to secure a sound and ethical development of a safe drug product
- Establish the Clinical Development Plan (CDP)
- Identify and coordinate contacts with external consultants and clinical experts
- Establish relevant external advisory boards, responsible for content
- Support and contribute to overall project deliverables
- Ensure that productive, innovative and high quality development is performed
- Secure the Benefit evaluation in Benefit: Risk team in partnership with Drug Safety
- Be the internal and external spokesperson for medical aspects in a given project
- Provides medical review and contribution to applicable Regulatory, and Drug Safety document.
What you'll need to succeed
- MD required
- Medical or Scientific insight within haemophilia
- Pharmaceutical industry experience
- Experience from working in clinical study.
- Medical Scientific excellence
- Excellent communication and presentation skills
- Initiative, Results oriented and delivery focus
- Collaborative with experience from working in clinical study team
- Experience from FDA and EMA interactions is a plus
- International and/or global HQ experience with track record in virtual communication, engagement and leadership is desirable.
Personal Attributes Required:
- Collaborative, a team player with strong interpersonal skills
- Able to work effectively in a team setting and interact respectfully with people of different cultural, seniority and functional backgrounds
- Sense of accountability and ownership; Able to work independently
- Engaged, driven, analytical
- Flexible and able to operate in a quickly changing environment
- Prioritization and time management skills.
The position is a full-time position and it is positioned in Stockholm. If you do not live in Stockholm, you should be able to either relocate or be able to commute 4 days/week.
VP Clinical Development
What you need to do now
If you're interested in this role, click 'apply now' and forward an up-to-date copy of your CV.
We are interviewing candidates on an ongoing basis, so we encourage you to send in your application as soon as possible. OBS: only one document can be submitted - if you have a cover letter, make sure it is on the same document as your CV. If you have questions, please contact Helena Marteus at HAYS on +46 (0)70 798 83 30.
Hays Denmark is part of Hays Plc, which is listed on London Stock Exchange (FTSE 250). Hays Plc is the world's leading recruiting experts in qualified, professional and skilled work.
We operate across the private and public sectors, dealing in permanent positions, contract roles and temporary assignments. We are market leaders in the UK and Australia, and one of the market leaders in Continental Europe. As of September 2011, the Group employed 7,600 staff operating from 255 offices in 31 countries across 20 specialisms.
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