Head of Medical Safety Science
Are you passionate about Medical Safety Science? Do you have experience from drug development to marketed products?
If so, now is your chance to join Ascendis Pharma as our new Head of Medical Safety Science.
As our new Head of Medical Safety Science, you will haveglobal responsibility for safety sciences support of all development and marketed products in Ascendis portfolio to meet GVP requirements. You will be leading a team in the Global Pharmacovigilance department which covers the drug safety surveillance, signal detection, safety evaluation, and safety management.
As our Head of Medical Safety Science you will join a very passionate and competent team where a wide collaboration and an international mindset are key factors in order to succeed. You will report to VP, Head of Pharmacovigilance and Global Drug Safety, who is located in Palo Alto, California.
Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day.As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
You will be responsible for:
- Management of a team of Medical Safety Scientists, Medical Safety Directors and other safety experts.
- Provide strategic oversight of the Medical Review of Individual Case Safety Reports (ICSR).
- Leading teams for safety science activities related to MAA and NDA filing.
- Providing expert guidance in responding to health authority safety queries.
- Building strong professional working relationship with both internal and external stakeholders.
Criteria of success in the role will be to:
- Work effectively, independently, and collaboratively.
- Have couple of hours of overlap of work hours with colleagues based in Palo Alto, California.
- Demonstrate strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment.
- Demonstrate ownership, initiative, and prioritization.
- Have ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting.
- Excellent communication skills, both written and verbal.
- Demonstrate strategic evaluation, analysis, and decision-making skills.
Your professional qualifications
You hold a relevant professional health care degree (M.D. Preferred) with appropriate clinical experience and minimum 10 years of experience within the pharmaceutical or biotechnology industries. You have extensive experience in a Medical Safety Sciences related role, with oversight of safety sciences fields and specific experience in epidemiology, quantitative methods, signal detection, data mining and benefit-risk. Furthermore, you have a proven track record of addressing and managing complex safety issues using scientific approaches in the pre-approval and post-approval environments. Expert knowledge of FDA safety regulations, ICH Guidelines, and safety databases is required.
Finally, you are proficient in English at a professional level, both written and spoken.
Travelling: 15 - 25 years a year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor, the canals, and the sea.
Applications will be evaluated when received, so please apply as soon as possible.
- You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
- Laptop, iPhone, paid internet, and home office equipment.
- A thorough and structured onboarding program.
- To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.
- Soft drinks, fresh fruit, and a wide variety of snacks every day, no strings attached.
- To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we will find a way to help you grow.