Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work:

This Senior MD position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process as well as line management responsibilities to medical team members in EMEA. As a member of the medical leadership team, the SMD is responsible for the oversight and development of the medical team and provides strategic leadership and business direction within the Pharmacovigilance (PV) department and across other functional areas requiring medical oversight.

Theyare responsible for the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations. The SMD also  leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives and the documentation of study results.

The SMD  may act as a clinical/medical representative in meetings with external stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed.

The SMD reports to the Regional Executive Medical Director.

A day in the Life:

• Provides medical content and leadership of clinical studies
• Has line-management responsibilities as well as provides strategic leadership for development of the global medical team in EMEA.
• Medical Monitoring of clinical studies
• Establishes and approves scientific methods underlying the design and implementation of clinical protocols
• Ensures study participant  safety
• Regularly reviews adverse event, laboratory and other clinical data, ensuring  reporting is done on a timely basis
• Collaborates with the study executives and independent safety committees when needed
• Demonstrates  medical leadership on the therapeutic areas and clinical trials
• Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
• Interprets, summarizes and documents clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
• Collaborates with leading academic medical centers
• Ensures study compliance by understanding and applying all relevant SOPs and GCPs
• Participates in long range strategic planning

Education

• MD degree with Board-certification in a therapeutic area
• A minimum of 5 years of clinical drug development experience in either a CRO or pharma.
• Desirable: Experience in the therapy areas Infectious Disease and Neurology, but not limited to these.

Knowledge, Skills, Abilities

• Demonstration and commitment to vigilant proactive problem solving

• Excellent leadership abilities

• Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols. Experience in clinical trial design, conduct and interpretation of clinical data.

• Previous experience with regulatory submissions is desirable.

• Excellent written and verbal communication skills.

• Ability to travel.

• Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values

• Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #Start Your Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http: //jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.