Senior Clinical Development Lead, Immunology and Indication Expansion, WCH
Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About This Role:
Reporting into the Head of Clinical Development, Immunology and Indication Expansion WCH, the Senior Clinical Development Lead (Senior MD), Immunology will have direct responsibility for advancing high priority clinical programs in all stages of development with a near term focus on early phase I-II programs for autoantibody driven diseases. The Senior Clinical Development Lead is an integral role requiring a blend of scientific acumen, strategic planning, and leadership. Primary responsibilities may include developing frameworks for new indications, assessing regulatory and relevant policies that could accelerate drug development timelines, designing clinical studies, and interpreting study data in close collaboration with WCH research and development teams. As a cornerstone of our clinical development team, your work will not only shape the trajectory of our WCH immunology pipeline but also contribute to the company's mission by providing vital insights into early development of research assets, external partnerships and due diligence activities. In addition, this person will also be responsible for building and managing a team of up to two direct reports, providing technical oversight and mentorship.
What You'll Do:
- Lead the design and execution of neuroimmunology/autoimmune programs through First-in-Human, Proof of Biology, pivotal, global registrational filings, and life-cycle expansion, with accountability for timelines, risk mitigation, and deliverables, including protocol development, study monitoring, data review, and analysis.
- Provide leadership to cross-functional project teams, ensuring seamless collaboration across clinical operations, biometrics, and more.
- Serve as medical monitor for early phase clinical trials, prioritizing patient safety and protocol adherence.
- Establish and foster relationships with key opinion leaders and clinical investigators in the field.
- Build and lead a high-performing team of Clinical Scientists and Medical Directors, addressing various immunology indications.
Who You Are:
You are a strategic thinker with a passion for advancing clinical development in immunology. Your expertise in neuroimmunology and autoimmune disorders is complemented by your ability to lead and inspire cross-functional teams. You thrive in collaborative environments and are adept at building relationships with external stakeholders, including key opinion leaders and clinical investigators. Your problem-solving skills are exceptional, and you have a track record of driving complex decisions with clarity and precision.
Required Skills:
- MD, PhD, or PharmD required, with subspecialty in neuroimmunology drug development strongly preferred.
- At least 6 years of experience in the biotech/pharmaceutical industry. with additional experience in clinical or academic research
- Proven track record of leading registration-stage programs or early clinical development programs with experience filing INDs.
- Experience interacting with global regulatory authorities.
- Deep scientific and clinical understanding of neuroimmunology/autoimmune disorders.
- Demonstrated ability to work effectively with cross-functional R&D partners.
- Experience leading cross-functional teams and mentoring clinical development professionals.
- Strong interpersonal skills, with the ability to establish and maintain relationships through a highly collaborative approach.
- Strong problem-solving, conflict resolution, and analytical skills.
- Ability to facilitate discussions among cross-functional groups and drive decisions on complex issues.
- Ability to travel domestically and internationally, approximately 10-20% of the time.
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Preferred Skills:
- Established network of global Key Opinion Leaders (KOLs).
This position is open to remote-US talent with an ideal placement in close proximity to our West Coast site in California. Travel is expected.
Job Level: Management
Additional Information
The base compensation range for this role is: $254,000.00-$349,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)