Discover Impactful Work as a Senior Medical Director in PPD:

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 other documents 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

Education

• 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

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.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.