Global Development Lead, Internal Medicine (Sr. Director)
$214,900–$358,100 year
On-siteNew York City, New York, United States or Tampa, Florida, United States
Job Summary
Lead the cross-functional Clinical Development Team in designing, executing, and interpreting studies to support worldwide regulatory submissions for Internal Medicine assets. Create and gain endorsement for the Clinical Development Plan, protocol design documents, and pediatric investigation plans while partnering with external companies under the Partner of Choice model. Provide specialized monitoring support, lead regulatory submission efforts including SCE, SCS, and DSURs, and develop product labels and benefit-risk reports. Interpret clinical trial data, engage external stakeholders like Ad boards and patient advocates, and ensure compliance with internal SOPs and external regulatory standards. Manage tradeoffs with the Prod Team Lead to secure global approval and reimbursement while maintaining a hybrid schedule with up to 30% travel.
Required Qualifications
- BS with 12 yrs or PhD with 7 yrs, relevant clinical/industry experience
- Experience leading cardiometabolic late-stage development programs, including type 2 diabetes
- Relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- Demonstrated clinical/medical, administrative, and project management capabilities
- Effective verbal and written communication skills in relating to individuals both inside and outside Pfizer
- Demonstrated experience managing and training large teams in clinical development
- Demonstrated experience in designing and launching large teams
- Medical / Scientific credibility/Excellence - Track record of achievement in pharmaceutical development
- Able to coordinate and execute clinical development or lifecycle strategy
- Demonstrated understanding of the complexities and recent developments in the principal disease areas
- Confident discussing scientific / mechanistic aspects of drug development
- Comfortable in discussing commercial and regulatory issues
- Able to work in a highly complex matrixed environment
- Able to influence cross-functional teams
- Persuasive and effective leader of staff
- Able to manage and motivate internal teams on clinical trials
- Able to act as mentor / coach to others to improve conflict management skills
- Prepared to take responsibility for a decision made and support this, even though it may be unpopular
- Shares wins and success
- Fosters open dialogue
- Lets people finish and be responsible for their work
- Defines success in terms of the whole team
- Creates strong morale and spirit in his/her team
- Creates a feeling of belonging to the team
- Take personal responsibility for results
- Pushing self and others to exceed goals and deliver results
- Able to demonstrate perspective and poise in the face of uncertainty
- Effectively get things done amidst organizational change
- The ability to influence and collaborate with peers
- Develop and coach others
- Oversee and guide the work of other colleagues to achieve meaningful outcomes
- Create business impact
- Up to 30% travel may be required
- Work on-site an average of 2.5 days per week
- Candidates must be authorized to be employed in the U.S. by any employer
- Permanent work authorization in the United States
Desired Qualifications
- Demonstrated experience in designing and launching large teams preferred
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