Program Team Lead, Early Development & Lifecycle Management, Nephrology
Biogen
6 months ago
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
What You’ll Do
- Lead the development and ongoing refinement of integrated clinical program development plans to maximize value creation and efficient execution.
- Establish and maintain clear program goals, timelines, and risk management strategies.
- Drive accountability among functional team members and ensure delivery of functional level plans.
- Represent the program internally and externally as needed, including at governance forums, engaging effectively with peers and senior stakeholders.
- Integrate scientific and business considerations to support clinical development plan execution and decision-making.
- Foster a strong team culture for planning and execution of clinical development strategies, prioritizing nimbleness and speed without sacrificing clarity or quality.
- Contribute to West Coast Hub and departmental best practices to promote program synergies.
Who You Are (Required Qualifications)
- Bachelor’s degree required; advanced degree strongly preferred (MS/MD/PhD/PharmD/MBA).
- 10–12 years of drug development experience in pharma or biotech.
- Proven track record of strategic leadership delivering complex cross-functional goals.
- Experience creating and executing integrated asset- or program-level development plans aligned with broader strategies.
- Strong understanding of therapeutic areas and optimal end-to-end development strategies.
- Ability to identify bottlenecks, surface issues, and drive timely escalation and resolution.
- Ability to anticipate internal/external drivers of change and communicate competitive/business implications of emerging scientific and medical data.
Preferred Skills
- Prior drug development experience with broad-potential immunology assets.
- Prior subcutaneous formulation development experience.
- Deep understanding of Minimum and Target Product Profile (MPP/TPP).
- Ability to assess and incorporate commercial/competitive/value considerations early into clinical strategy and MPP/TPP.
- Working knowledge of US and ex-US regulatory requirements/processes.
- Knowledge of key IND-enabling pharmacology, toxicology, and CMC activities.
- Experience executing early clinical studies to minimize risk and deliver proof-of-concept.
- Experience executing pivotal clinical studies for drug registration.
Benefits (as stated)
- Medical, Dental, Vision, & Life insurances; Fitness & Wellness programs (fitness reimbursement); Short- and Long-Term Disability; Paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 company paid holidays + 3 paid days off; 80 hours sick time/year; Paid Maternity and Parental Leave; 401(k) match; Employee stock purchase plan; Tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
- Lead the development and ongoing refinement of integrated clinical program development plans to maximize value creation and efficient execution.
- Establish and maintain clear program goals, timelines, and risk management strategies.
- Drive accountability among functional team members and ensure delivery of functional level plans.
- Represent the program internally and externally as needed, including at governance forums, engaging effectively with peers and senior stakeholders.
- Integrate scientific and business considerations to support clinical development plan execution and decision-making.
- Foster a strong team culture for planning and execution of clinical development strategies, prioritizing nimbleness and speed without sacrificing clarity or quality.
- Contribute to West Coast Hub and departmental best practices to promote program synergies.
Who You Are (Required Qualifications)
- Bachelor’s degree required; advanced degree strongly preferred (MS/MD/PhD/PharmD/MBA).
- 10–12 years of drug development experience in pharma or biotech.
- Proven track record of strategic leadership delivering complex cross-functional goals.
- Experience creating and executing integrated asset- or program-level development plans aligned with broader strategies.
- Strong understanding of therapeutic areas and optimal end-to-end development strategies.
- Ability to identify bottlenecks, surface issues, and drive timely escalation and resolution.
- Ability to anticipate internal/external drivers of change and communicate competitive/business implications of emerging scientific and medical data.
Preferred Skills
- Prior drug development experience with broad-potential immunology assets.
- Prior subcutaneous formulation development experience.
- Deep understanding of Minimum and Target Product Profile (MPP/TPP).
- Ability to assess and incorporate commercial/competitive/value considerations early into clinical strategy and MPP/TPP.
- Working knowledge of US and ex-US regulatory requirements/processes.
- Knowledge of key IND-enabling pharmacology, toxicology, and CMC activities.
- Experience executing early clinical studies to minimize risk and deliver proof-of-concept.
- Experience executing pivotal clinical studies for drug registration.
Benefits (as stated)
- Medical, Dental, Vision, & Life insurances; Fitness & Wellness programs (fitness reimbursement); Short- and Long-Term Disability; Paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 company paid holidays + 3 paid days off; 80 hours sick time/year; Paid Maternity and Parental Leave; 401(k) match; Employee stock purchase plan; Tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.