Match score not available

Associate Medical Director / Medical Director, Clinical Science

Remote: 
Full Remote
Contract: 
Salary: 
180 - 250K yearly
Experience: 
Expert & Leadership (>10 years)
Work from: 
Massachusetts (USA), United States

Offer summary

Qualifications:

Medical degree in hematology, oncology, or immunology required., Solid record in drug development programs., Knowledge of GCP, ICH, and regulatory requirements., Advanced English proficiency., Desired expertise in medical perspectives for business development..

Key responsabilities:

  • Lead Sobi-sponsored studies and trials.
  • Provide input on clinical trial protocols and regulatory documents.
  • Manage medical monitoring activities for Phase 2-4 trials.
  • Collaborate with cross-functional clinical teams.
  • Represent Sobi at scientific congresses and meetings.
Sobi - Swedish Orphan Biovitrum AB (publ) logo
Sobi - Swedish Orphan Biovitrum AB (publ) Pharmaceuticals Large https://www.sobi.com/
1001 - 5000 Employees
See more Sobi - Swedish Orphan Biovitrum AB (publ) offers

Job description

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.

Our mission and culture at Sobi North America 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
  • Generous time off policy
  • Summer Fridays
  • Opportunity to broaden your horizons by attending popular conferences
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

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.

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]

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.

 

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Industry :
Pharmaceuticals
Spoken language(s):
EnglishEnglish
Check out the description to know which languages are mandatory.

Other Skills

  • Organizational Skills
  • Leadership
  • Decision Making
  • Self-Motivation
  • Verbal Communication Skills

Operations Director Related jobs