Senior Medical Director

The Senior Medical Director has advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line management accountability. They work collaboratively and serve as the primary point of contact between the PV Medical Director team and and other functional leads within the organisation. They are expected to rovide leadership and strategy to multidisciplinary teams within PV and across the company. The Senior Medical Director provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process. The PPD Medical Directors remit includes design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable GCP regulations as well as leadership and contributions to the analysis of study results and assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives. The Medical Director acts as a clinical/medical representative in meetings with external stakeholders (e.g. study sponsors, , Key Opinion Leaders (KOLs), investigators, regulatory authorities, etc.), partners (e.g. vendors, consultants, etc.) and other external audiences as needed. A day in the Life:

• Provides regional medical leadership, mentoring and oversight to direct reports and global Medical Director physician team.
• Serves as consultant and spokesperson of the medical team
• Provides medical content and leadership of the clinical studies
• Provides Medical Monitoring of Phase I-IV clinical studies
• Establish and approve scientific methods underlying the design and implementation of clinical protocols
• Monitors study subject safety
• Reviews adverse events, laboratory and other clinical data
• Collaborates with the study executive and independent safety committee when needed
• Represents clinical researc through membership on trial teams.
• 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 otherdocuments requiring medical expertise for the conduct of clinical trials
• Interprets, summarizes and documents study data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
• Collaborates with leading academic medical centers
• Guides and motivates clinical investigators
• Ensures study compliance by understanding and applying all relevant SOPs and GCPs
• Participates in long term strategic planning
  
  MD degree, preferably with a (sub)specialty
• Minimum 5 years of clinical and clinical drug development experience
Knowledge, Skills, Abilities
• Demonstration and commitment to vigilant proactive problem solving
• Excellent leadership abilities
• Ability to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
• Expertise in clinical trial design, conduct and interpretation of clinical data.
• Excellent written and verbal communication skills.
• Flexibility to travel domestically and internationally
• Ability to effectively manage direct reports
  
  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 all aspects of clinical research from Phase I to Phase IV. . Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future., 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. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.