Associate Director Medical Affairs

Dr Reddys Laboratories   •  

Princeton, NJ

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 64 days ago

This job is no longer available.

Medical AffairAssociate Directorwill report to the VPPromiusMedical Affairs (PMA) and will be responsible for medical strategy and life cycle management for branded products which includes analysis plan for phase 3 trials, planning of phase 4 studies. AD would also be responsible for leading a migraine survey conducted in 15,000 patients which is a landmark study. Additionally AD would be involved in managed care presentations, external scientific affairs operations and training, HCP engagements and conducting advisory board with leading key opinion leaders. This position requires a combination of medical, clinical pharmacology, scientific, analytical, organizational, and interpersonal skills.

Job Responsibilities:

• Responsible for medical strategy and life cycle management for branded products. Work on data analysis plan and execute post-hoc analysis on relevant phase 3 clinical studies. In addition finalize the study designs and endpoints for phase 4 studies. Work on clinical segmentation and provide medical support on positioning strategy.

• Complete the data analysis for the landmark migraine survey. Finalize publication plan and publish data results in relevant journals. Present abstracts/posters in various conferences

• Initiate and execute another major survey in Psoriasis patients (approximately 3000-5000 patients)

• Prepare and give medical presentations to managed care on approved branded products justifying the relevant unmet needs addressed by Promius products. Manage day to day operations of the external scientific affairs (ESA) activities of PMA, including HCP engagement, medical affairs booth staffing and scientific congress attendance to ensure timely and compliant activities in support of PMA strategic imperatives.

• Engage key opinion leaders and conduct medical advisory boards

• Develop, implement, and track ESA Training programfor medical affairscompliance, therapeutic area, and product data to ensure performance excellence of ESA activities.

• Support development and tracking of performance metrics for PMA ESA activities.

• Interact with clinical development and commercial groups as necessary to finalize medical strategy for branded products

• Participate as individual contributor and mentor for HCP engagement activities to medical affair fellows

• Manage PMA scientific congress attendance via strategic conference planning, pre-meeting preparation, and post-meeting reporting of scientific and competitive intelligence.

• Manage Educational Grant approval process and tracking to ensure compliance with SOPs and applicable guidances and timely processing of PEG program applications, interfacing with legal and finance groups as necessary.

• Manage tracking of escalated enquiries from the Medical Information Call center and oversee responses by PMA team. Ensure compliant and scientifically balanced and accurate responses to HCP enquiries about Promius products.

• Support PMA director on strategic planning and support the PMA director as necessary.

Desired Skill & Experience:

  • Medical and scientific degree: MD with scientific degree such as clinical pharmacology or postdoctoral fellowship in pharmacology.
  • Minimum 4 years of relevant experience. This experience should be in medical affairs or combination of experience in conducting clinical trials/commercial strategy and medical affairs
  • Previous experience in neurology, dermatology, migraine, psoriasis or similar therapeutic areapreferred.
  • Understanding of clinical pharmacology of drugs and able to interpret phase 3 clinical data
  • Able to present and communicate clinical data and medical strategy to senior executives of the company
  • Experience in HCP engagement and conducting medical advisory boards
  • Must be a strong team player and effectively collaborate with internal departments in a strongly matrixed environment.
  • Understanding of US healthcare environment, clinical research processes, FDA regulations and ethical guidelines
  • Understanding of the process for developing medical information response documents using regulatory information, published medical literature, clinical study reports, posters, and abstracts
  • Excellent organizationskills
  • Strong working knowledge of MS Office suite required
  • Able to adapt to changing requirements
  • Ability to meet deadlines
  • Ability to travelto various meetings up to30% of time, including weekends, when required for congress attendance or HCP meetings. Some international travel may be required.


Education Required: Medical and scientific degree: MD with scientific degree such as clinical pharmacology or postdoctoral fellowship in pharmacology.
Years of Experience: Minimum 4 years of relevant experience. This experience should be in medical affairs or combination of experience in conducting clinical trials/commercial strategy and medical affairs