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Associate Medical Director Clinical Science

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

  • Competitive compensation for your work
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Opportunities for professional growth
  • Diversity and Inclusion
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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 [email protected].

 

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Average salary estimate

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$100000K
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What You Should Know About Associate Medical Director Clinical Science, Sobi

Are you ready to make a real impact in the world of rare disease treatment? As an Associate Medical Director Clinical Science at Sobi in Basel, Switzerland, you'll join a team dedicated to improving the lives of patients who need it most. We're searching for a medical expert who’s not just looking for a job, but a mission-driven opportunity where you can contribute your talents to innovative therapy development. In this role, you will be responsible for leading clinical development activities, driving the design and conduct of sponsor studies, and collaborating with cross-functional teams to push our therapies forward. Sobi believes that every unique contribution matters; hence, we encourage individuals from diverse backgrounds to apply, as we aim to create a team where everyone feels valued. You’ll interact with key opinion leaders and guide clinical study protocols while providing invaluable insights that blend scientific rigor with strategic thought. With competitive compensation, a balanced work/life approach, and a culture that prioritizes growth, diversity, and real impact, Sobi is the place to be if you’re passionate about making a difference in the field of medical science. Join us, and together, we can change lives!

Frequently Asked Questions (FAQs) for Associate Medical Director Clinical Science Role at Sobi
What does an Associate Medical Director Clinical Science at Sobi do?

The Associate Medical Director Clinical Science at Sobi plays a crucial role in overseeing clinical development activities, ensuring that clinical trials adhere to the highest scientific and ethical standards. This position involves providing medical and strategic input to clinical development plans, conducting and reporting sponsor studies, and collaborating with various teams to ensure successful execution of our development programs.

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What qualifications are needed for the Associate Medical Director Clinical Science position at Sobi?

To qualify for the Associate Medical Director Clinical Science role at Sobi, a medical degree is required along with at least 3-4 years of clinical experience in treating patients, preferably in rheumatology or immunology. Candidates should also demonstrate a strong record in drug development programs and the ability to effectively collaborate across various departments.

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How can I apply for the Associate Medical Director Clinical Science role at Sobi?

To apply for the Associate Medical Director Clinical Science position at Sobi, interested candidates should visit the careers section of our website where current vacancies are listed. Be sure to submit a comprehensive CV and a cover letter that highlights your relevant experience and passion for rare disease treatment.

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What is the work culture like for an Associate Medical Director Clinical Science at Sobi?

The work culture for an Associate Medical Director Clinical Science at Sobi is collaborative and team-oriented. We genuinely care about our staff's well-being and foster an environment that emphasizes diversity and inclusion. Employees take pride in working together towards a common mission of helping those affected by ultra-rare diseases.

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What career growth opportunities are available for Associate Medical Directors Clinical Science at Sobi?

At Sobi, we are invested in the growth of our employees. As an Associate Medical Director Clinical Science, you will have opportunities for professional advancement and mentorship from experienced leaders in the biopharmaceutical field. Furthermore, we encourage ongoing education and training to deepen your expertise.

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What types of projects will an Associate Medical Director Clinical Science work on at Sobi?

An Associate Medical Director Clinical Science at Sobi will work on various projects related to clinical trial design and execution primarily focused on rare disease treatments. This includes developing clinical study protocols, engaging with key opinion leaders, and contributing to regulatory submissions. You'll be pivotal in bringing innovative therapies to market.

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Does Sobi offer remote work options for the Associate Medical Director Clinical Science role?

Yes, Sobi supports flexible working arrangements, including remote work options for the Associate Medical Director Clinical Science role. We believe in providing a work environment that allows our employees to excel while maintaining a healthy work/life balance.

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Common Interview Questions for Associate Medical Director Clinical Science
Can you describe your experience with clinical trials in rheumatology or immunology?

Be prepared to share specific examples of your involvement in rheumatology or immunology clinical trials. Discuss your role, the challenges faced, and how you contributed to study design, execution, or data analysis. Highlight any successful outcomes that resulted from your contributions.

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What strategies do you use to ensure adherence to ethical standards in clinical research?

Explain your understanding of ethical standards in clinical research, emphasizing the importance of informed consent, patient safety, and regulatory compliance. Discuss strategies you have implemented in past roles to maintain these standards during clinical trials.

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How do you approach communicating with cross-functional teams?

Highlight your communication skills and how you facilitate collaboration among diverse teams. Provide examples of how you've effectively shared information, resolved conflicts, or gained consensus among stakeholders to keep projects running smoothly.

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Describe a challenging situation you faced in a clinical setting and how you overcame it.

Use the STAR method (Situation, Task, Action, Result) to outline a challenging situation. Describe the context, your responsibilities, the actions you took to address the challenge, and the positive outcomes that followed, showcasing your problem-solving skills and resilience.

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What is your experience with regulatory submissions and interactions with health authorities?

Discuss your familiarity with the regulatory submission process, including writing and reviewing documents for IND applications or marketing authorizations. Highlight any direct interactions you’ve had with health authorities and how you navigated these discussions effectively.

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Can you provide an example of how you incorporated scientific input into a clinical development plan?

Share a specific instance where your scientific expertise influenced a clinical development plan. Detail the context of your input, the stakeholders involved, and how your suggestions positively impacted the project.

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How do you ensure patient safety in clinical studies?

Emphasize your commitment to patient safety by discussing protocols you follow for monitoring adverse effects, ensuring continuous risk assessment, and how you maintain communication with study participants to safeguard their wellbeing.

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What motivates you to work in the field of rare diseases?

Connect your personal or professional motivations to the importance of rare diseases. Discuss any relevant experiences that shaped your desire to contribute to this field and how they align with Sobi’s mission to make impactful advancements in treatment.

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Explain how you stay updated with the latest advancements in clinical science.

Discuss your methods for staying informed, such as attending conferences, reading scientific literature, or participating in professional organizations. Highlight your commitment to continuous learning and how it benefits your role at Sobi.

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What role do you see yourself playing in our team at Sobi?

Outline how your skills and experiences align with the responsibilities of the Associate Medical Director Clinical Science role. Emphasize your enthusiasm for collaboration, your goal of driving clinical projects forward, and your dedication to making a positive impact in rare disease treatment.

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Our mission here at Sobi is to develop and deliver innovative therapies and services to improve life for people living with rare diseases.

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Full-time, hybrid
DATE POSTED
November 28, 2024

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