Title:  Senior Director Medical Affairs - Scientific Operations LCM Lead

SUN PHARMA, Princeton, New Jersey (ON-SITE HYBRID: 3 days in office; 2 days remote)

Senior Director Medical Affairs – Scientific Operations LCM Lead

Summary:

The Senior Director Medical Affairs – Scientific Operations LCM Lead will report to the AVP, Head of Scientific Communications and Operations. This individual will be responsible for providing scientific and clinical development guidance across the branded portfolio. They will be responsible for conducting interventional Phase III-IV studies conducted by Medical Affairs and well as tracking progress on observational studies and overseeing the biostatistics team working on data mining and data generation activities. This position is located in Princeton, New Jersey.  The workweek is HYBRID:  3 days in office; 2 days remote. 

The incumbent will be responsible for development and execution of the North America Medical Affairs evidence generation plan working in collaboration with the therapeutic area leads, medical directors and the global clinical development teams.

Additionally, the incumbent will represent North America as the Clinical Development expert on key life cycle management activities.

The individual will conduct his/her work activities in compliance with all relevant regulations, including CFR, ICH guidelines, and PhRMA guidelines as well as all Sun Pharmaceuticals policies, and procedures.

Responsibilities:

• The incumbent is the internal scientific expert in the disease area and scientific aspects of the competitive landscape and will be responsible for ensuring the medical/scientific validity and integrity of the clinical development program and study protocols.
• Will play a key role in study planning, protocol development and oversight of the clinical trials as well as oversee the development of the clinical study reports (CSRs)
• Serve as the key contact for relationships to external experts, key opinion leaders and investigators as well as provide regular scientific-medical disease state updates, etc.
• Oversee the study vendors and biostatistician team in data generation and analysis
• Work in close collaboration with the clinical operations team
• Be responsible for the leadership and results of a cross functional global project development team throughout the global development process.
• Provide strategic and/or technical consultations on behalf of the therapeutic area (e.g., study design, business development, marketing, communications, training, legal, etc.)
   

Qualifications

• MD, PhD or PharmD strongly preferred.
• Therapeutic Area experience strongly preferred.
• 10+ years relevant clinical/drug development experience including experience working in clinical research/medical affairs with a strong understanding of the clinical and global drug development process.
• 5+ years’ experience as a cross-functional team leader preferred.
• Ability to travel up to 30% of time.