Associate Medical Director / Medical Director, Clinical Science
Anywhere, United States
Job Description
The Clinical Scientist is responsible for Sobi’s clinical development activities for the therapeutic and serves as a medical expert on matters relating to the therapeutic, including regulatory, drug safety, and business development. The Clinical Scientist is responsible for management and review of clinical trials and product development. Specific tasks may include clinical protocol development, medical monitoring of clinical trials, analysis of study data, and preparation of trial reports and related regulatory documents. Additional roles in publication planning and writing may be included. This position will involve representing Sobi at scientific congresses, as well as at clinical and business development meetings.
Essential to success is excellent medical knowledge, ability to build and maintain strong relationships with study investigators / key opinion leaders (KOLs), and outstanding internal partnerships.
Qualifications
Including, but not limited to the following
- Design, conduct and report Sobi-sponsored studies. Lead medical monitoring activities for Phase 2-4 clinical trials, including overseeing external medical monitoring vendors / clinical research organizations (CROs).
- Provide medical input on clinical trial protocols, regulatory documents, advisory boards, educational materials, and publications.
- Work with cross-functional clinical team, including clinical operations, clinical pharmacology, pharmacovigilace, statisticians, data management, and members of multidisciplinary project teams to guide data collection and data interpretation. Support to other functions within Sobi on matters related to pacritinib.
- Participate in company interactions with regulatory agencies.
- Must have knowledge of GCP, ICH and other regulatory requirements for evaluating and reporting adverse events, clinical trial data, clinical brochures and scientific publications.
Travel for internal meetings or for external conferences or site visits, up to 10%
Education/Learning Experience/Work Experience
Required:
- Medical degree with specialty in hematology, oncology, or immunology is required
- Solid record of accomplishment in drug development programs within haematology, oncology, or immunology demonstrating outstanding and intimate understanding of translating early stage programs into the clinic and further across the clinical development chain
Desired: - Expertise in bringing the medical and scientific perspective, drug development wisdom to business development, corporate strategy and leadership decision making
- Track record of scientific publications, including manuscripts and abstracts
Skills/Knowledge/Languages
Required:
- 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.
- Advanced level level of English
Desired:
Able to demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.
Personal Attributes
Required:
- Good team-player with high personal and scientific integrity
- Comfortable working in fast paced environment
Additional Information
The base salary pay range for this role is $180,000-$250,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.
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.
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Career Focus: Regulatory, Clinical Operations, Medical Affairs
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