Associate Medical Director Clinical Science

4 giorni fa

Milano, Italia Sobi A tempo pieno

Job Description Role & Function The Associate Director Clinical Science is responsible for Sobi's clinical development activities and serves as scientific and medical expert on matters relating to the assigned development program including regulatory and drug safety.
Key Responsibilities Provide clinical, medical, and strategic input to clinical development plans, while adhering to the highest scientific and ethical standards Responsible for planning, designing, conducting (including medical monitoring) and reporting Sobi-sponsored studies, in close collaboration with the Medical Development Lead (MDL), Medical Program Lead (MPL) and clinical study teams, regulatory, safety and other cross-functional HQ teams, as applicable.
Act as Study Physician responsible for Sobi-sponsored studies.
Member of the Medicine Development Team and of Clinical Study Team(s).
Interact and consult with key opinion leaders and lead advisory boards to define the development plan for new products/indications.
Responsible for the development of clinical study synopsis and protocols, contribute to the statistical analysis plans, participate in Investigator meetings and other study-related activities and provide input/review of other main clinical study documents, as needed and appropriate.
Provide strategic and operational clinical development expertise in interactions with regulatory and reimbursement authorities.
Contribute with high-quality scientific and medical input to delivery of clinical parts of submissions and other regulatory documents as well as to responses to Health Authority's questions to support e.g., scientific advice, IND application, marketing authorization.
Where applicable and assigned, provide scientific and medical expert support to other functions within Sobi on specific therapeutic area of expertise, including global safety, medical affairs activities such as advisory boards, scientific communications & publications, and business development such as due diligence evaluations of external compounds and M&A.
Qualifications Medical Degree required.
At least 3-4 years clinical experience treating patients (rheumatology/immunology preferred) and/or at least 4-5 years of solid record of accomplishment within rheumatology/immunology drug development programs demonstrating outstanding and intimate understanding of various phases of clinical trials.
Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making.
Good communication skills, capable of representing the company to all audiences both internally and externally, particularly in the context of collaborations at international conferences and scientific symposia.
Good organizational skills, be a self-motivated driver of best practices and processes in the management of projects and operations.
Good team-player with high personal and scientific integrity.
Comfortable working in fast paced environment.
Able to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
Ability to work effectively in a matrix, cross-functional setting; excellent collaboration skills; and experience working with co-development/co-commercialization industry partners would be beneficial.
Able to work well in a virtual environment.
Proven self-management by showing initiative, good organization and willingness to be held accountable.
Profiecient level of English Additional Information   Why Join Us?
We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate.
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity.
Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here.
If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that.
We offer a competitive benefits package, to support the health and happiness of our staff.
Sobi Culture At Sobi, we refuse to accept the status quo.
This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases.
And we see this focus as a strength.
By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them.
This has been our approach since day one, but we know we can't change the world of rare diseases on our own.
Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain.
Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.
Sobi is an affirmative action and equal opportunity employer.
Disabled/Veterans.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability.
You can request reasonable accommodations by sending an email to ******.

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