Career Possibilities: Clinical, Regulatory, and Development


In the world of business, careers are no longer linear or predictable. What was once a clearly sign-posted path as you progressed through milestones, a career road map is now circuitous presenting new challenges and opportunities at every bend. Life-long careers in one sector or one company are becoming a rarity as new technologies and shifting social norms disrupt traditional careers. Both employers and employees are seeking more diversity of experience, lifestyle flexibility and alternative paths.

This panel is designed to help you think about your career path and the different options that are open to you. The panel will have an informational interview type feel with panelists sharing their career paths, a look at what their job entails, transferrable skills for those looking to make a change, tips for uncovering opportunities, advice for others, and how to make brave leaps. This panel discussion will be moderated by Jackie Schumacher, Regulatory and Quality Lead at Rallybio.

Panelists include
- Gersham Dent, Senior Director of Clinical Imaging, Biogen
- Jana Subramanyam, VP of Regulatory, Allena
- Debi Tran, Sr. Director, Regulatory Affairs (Global Lead for Lumasiran), Alnylam Pharmaceuticals 
- Nadia Zakaria, Director of Translational Medicine, Novartis  

Panelists' Bios are below 

 

Date and Time:  
March 3, 2021
4:00-5:30 PM
  EST

Agenda:  
4:00-4:05pm: Welcome
4:05-5:10pm: Panel discussion
5:10-5:30pm: Small group speed networking (2 rounds)

 

Location: 
Zoom

 

Cost: 
Members, Students, Postdocs: $5; Non-Members: $15

Given our mission is to promote women's development in STEM we would like to offer a free spot in our workshops to those in transition between jobs or who cannot afford the ticket price. Please contact [email protected] if you qualify.


 
Register

 

See other events in this series
1/20: Career Possibilities Panel: New Commercial Strategy, Product Planning, Marketing
2/10: Career Possibilities Panel: Discovery, Research
3/24: Career Possibilities Panel: Portfolio Strategy, Project Management, Scientific Operations
4/14: Career Possibilities Panel: Medical Affairs-Comms, Publications, Medical Science Liaison
5/05: Career Possibilities Panel: Business Development and Intellectual Property

 

Jana Subramanyam, VP of Regulatory at Allena

Regulatory Affairs professional with 20 years strategic experience with FDA, EMA and Health Canada regulations. Proven history of successful leadership of teams including multiple approvals (drugs, biologics & medical imaging agents). Strategic and operational oversight of regulatory activities; including Clinical, Preclinical & Manufacturing development, global Phase II & Phase III clinical trials, approval of products in the United States, Europe and Canada including strategic regulatory assessment of products for business development activities. Skilled liaison with proven leadership skills and experience interfacing with external organizations, regulatory agencies for US, Canada & EMA in support of Company submissions and Health Authority inspections (Pre-Approval and Pharmacovigilance). Strengths include providing strategic input to cross functional teams, management of departmental operations, project management related to submission activities, as well as leading and mentoring multi-functional teams. Exceptionally organized and articulate; possessing strong interpersonal skills and a flexible work style to effectively collaborate with individuals at all levels in a matrix environment.

Debi Tran, Sr. Director, Regulatory Affairs (Global Lead for Lumasiran) at Alnylam Pharmaceuticals

Debi Tran has 19 years of broad regulatory experience, including 4 years at the FDA and USPHS, in addition to 15 years in pharmaceutical industry (Alnylam, Pfizer, Wyeth, Merck). Debi has global experience with early and late stage development programs across various therapeutic modalities (RNAi therapy, gene therapy, vaccines, small molecules) in multiple therapeutic areas including rare diseases. Debi has led global registration filings, PMR/PMC/labeling negotiations, IND/CTA submissions, global regulatory agency engagements, regulatory designation applications, policy development, and process improvement. Prior to joining regulatory strategy, Debi worked in regulatory advertising and promotion, reviewing promotional materials to ensure compliance with applicable regulations and guidances. She is currently a Senior Director, Regulatory Portfolio Lead at Alnylam with oversight and accountability for a portfolio of liver-targeted early candidates and mid to late stage programs, and management of a talented team of regulatory colleagues. Debi has a Doctorate of Pharmacy degree from the University of the Sciences in Philadelphia. She enjoys reading, cooking, nature walks, and spending time with her family (3 kids, husband and dog) at the beach.