Global Medical Program Director Haemophilia - Sweden
Want to know company name or location? Company managed [?]
- Our company has an exciting and expanding portfolio, which are 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 our company is now looking to recruit an outstanding medically-qualified individual to become Medical Program Director within heamophilia 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.
- Be the internal and external spokesperson for medical aspects in a given project.
- Secure the Benefit evaluation in Benefit: Risk team in partnership with Drug Safety.
- Provides medical review and contribution to applicable Regulatory, and Drug Safety document.
- Medical Doctor
- Medical &Scientific insight within haemophilia
- 5 years of pharmaceutical industry experience
- Clinical and academic experience
- 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.
- 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