Biogen
VP, Clinical Development, Immunology and Indication Expansion, WCH
Biogen, San Francisco, California, United States, 94199
Overview
The VP, Clinical Development, Immunology and Indication Expansion – West Coast Hub (WCH) leads the clinical development strategy for a growing portfolio of early phase immunology assets and expansion into new indications. This role requires close collaboration with Biogen’s Research, Development, and Commercial teams to ensure alignment across discovery, translational, and clinical efforts. The leader oversees direct and matrixed teams of Medical Directors, Clinical Scientists, and Clinical Development staff, fostering a science-first culture focused on delivering best-in-class clinical programs. The VP will work with the WCH Development organization to expand the immunology clinical development strategy across a broader therapeutic landscape, including program and team building, strategic planning, life-cycle management, and efficient execution of Phase 1–3 trials and global regulatory filings. This role drives a high-performing clinical organization committed to delivering transformative therapies to patients with a sense of urgency. This position is a hybrid-based role in South San Francisco, CA. Consideration may be given to individuals able to commute to CA regularly from US-Remote locations. Main Responsibilities
The individual in this position provides medical and strategic leadership for the development of disease area strategy and individual clinical programs within WCH’s immunology portfolio. They influence internal and external regulatory, scientific, and business decisions impacting the company’s overall portfolio. The ideal candidate leads complex development programs and interacts with executive leadership, regulators, the medical community, and external partners within a rapidly growing organization. Recruit, lead, and develop a high-performing team of Medical Directors and Clinical Scientists focused on bringing important therapies to patients, ensuring scientific rigor, mentorship, and growth opportunities within the enterprise. Develop integrated disease area strategies in partnership with Research leadership that encompass translational and clinical insights and provide clinical development oversight of WCH clinical immunology portfolio. Create and own the clinical portfolio strategy for immunology indications, providing clinical guidance for IND-enabling activities and early clinical experimentation. Serve as the medical and strategic leader for assigned programs, leveraging deep expertise in immunology. Lead and oversee the execution of immunology 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. Collaborate closely with Research counterparts to ensure smooth program transition from discovery to development and optimize biomarker strategies and patient selection. Lead Global Trial Execution, managing region-specific regulatory requirements and fostering collaboration across global teams. Serve as medical Monitor for early phase clinical trials, ensuring patient safety, protocol adherence, and timely issue resolution. Work cross-functionally with Clinical Operations, Biometrics, Regulatory, Clinical Pharmacology, Biomarker, Commercial, and Medical Affairs teams to ensure seamless program execution. Partner with External Innovation and Business Development to identify, evaluate, and integrate external clinical-stage assets that complement the internal pipeline. Represent the disease area and development programs to internal governance, including Executive Leadership, Board of Directors, and Portfolio Review Committees. Actively participate in R&D leadership initiatives and strategic planning to shape the future direction of the company’s development portfolio. Serve as a matrix leader on cross-functional development teams; support and guide clinical study designs, protocol development, data interpretation, and regulatory interactions. Maintain relationships with key opinion leaders, academic institutions, and regulatory investigators in immunology. Represent Biogen in external forums and scientific partnerships in broad immunology indications. Strong cultural alignment with WCH’s collaborative and solutions-driven approach, bringing curiosity, adaptability, and a bias for execution to complex challenges. Qualifications
The ideal candidate will have the following mix of professional and personal characteristics: Professional Qualifications MD, PhD, or PharmD required; subspecialty in immunology drug development strongly preferred. At least 15 years of relevant experience in clinical research, with a minimum of 10 years in the biopharmaceutical industry. Proven track record of leading successful clinical development programs from early to late stage; experience in IND submissions and global regulatory interactions preferred. Deep scientific and clinical understanding of nephrology and broad immune-mediated diseases. Demonstrated ability to work effectively with cross-functional R&D partners including research, translational science, clinical operations, and regulatory affairs. Experience as a Sponsor Representative in regulatory agency meetings, including preparation and presentation of briefing materials. Breadth of Immunology Expertise, with demonstrated leadership across multiple indications. Experience leading cross-functional teams and mentoring clinical development professionals. Strong strategic thinking and problem-solving skills, with the ability to navigate ambiguity and complexity. Excellent communication and executive presence; capable of interacting credibly with internal leadership, external partners, and regulatory agencies. Personal Characteristics Action-oriented and entrepreneurial mindset, with a demonstrated ability to thrive in dynamic, fast-paced environments; prior experience in start-up or high-growth settings is valued but not required. Purpose-driven leader with a passion for improving outcomes in underserved patient populations. Collaborative, self-aware, and comfortable leading through influence across a matrixed organization. High integrity, with a strong sense of accountability and urgency. Committed to the growth and success of team members, fostering a culture of inclusion, learning, and excellence. Enterprise-minded leader who considers organizational impact and cross-functional interdependencies in decision-making. Able to inspire confidence and trust internally and externally, including among KOLs and partners in the nephrology field. Additional Information The base compensation range for this role is: $335,000.00-$486,000.00 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. #J-18808-Ljbffr
The VP, Clinical Development, Immunology and Indication Expansion – West Coast Hub (WCH) leads the clinical development strategy for a growing portfolio of early phase immunology assets and expansion into new indications. This role requires close collaboration with Biogen’s Research, Development, and Commercial teams to ensure alignment across discovery, translational, and clinical efforts. The leader oversees direct and matrixed teams of Medical Directors, Clinical Scientists, and Clinical Development staff, fostering a science-first culture focused on delivering best-in-class clinical programs. The VP will work with the WCH Development organization to expand the immunology clinical development strategy across a broader therapeutic landscape, including program and team building, strategic planning, life-cycle management, and efficient execution of Phase 1–3 trials and global regulatory filings. This role drives a high-performing clinical organization committed to delivering transformative therapies to patients with a sense of urgency. This position is a hybrid-based role in South San Francisco, CA. Consideration may be given to individuals able to commute to CA regularly from US-Remote locations. Main Responsibilities
The individual in this position provides medical and strategic leadership for the development of disease area strategy and individual clinical programs within WCH’s immunology portfolio. They influence internal and external regulatory, scientific, and business decisions impacting the company’s overall portfolio. The ideal candidate leads complex development programs and interacts with executive leadership, regulators, the medical community, and external partners within a rapidly growing organization. Recruit, lead, and develop a high-performing team of Medical Directors and Clinical Scientists focused on bringing important therapies to patients, ensuring scientific rigor, mentorship, and growth opportunities within the enterprise. Develop integrated disease area strategies in partnership with Research leadership that encompass translational and clinical insights and provide clinical development oversight of WCH clinical immunology portfolio. Create and own the clinical portfolio strategy for immunology indications, providing clinical guidance for IND-enabling activities and early clinical experimentation. Serve as the medical and strategic leader for assigned programs, leveraging deep expertise in immunology. Lead and oversee the execution of immunology 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. Collaborate closely with Research counterparts to ensure smooth program transition from discovery to development and optimize biomarker strategies and patient selection. Lead Global Trial Execution, managing region-specific regulatory requirements and fostering collaboration across global teams. Serve as medical Monitor for early phase clinical trials, ensuring patient safety, protocol adherence, and timely issue resolution. Work cross-functionally with Clinical Operations, Biometrics, Regulatory, Clinical Pharmacology, Biomarker, Commercial, and Medical Affairs teams to ensure seamless program execution. Partner with External Innovation and Business Development to identify, evaluate, and integrate external clinical-stage assets that complement the internal pipeline. Represent the disease area and development programs to internal governance, including Executive Leadership, Board of Directors, and Portfolio Review Committees. Actively participate in R&D leadership initiatives and strategic planning to shape the future direction of the company’s development portfolio. Serve as a matrix leader on cross-functional development teams; support and guide clinical study designs, protocol development, data interpretation, and regulatory interactions. Maintain relationships with key opinion leaders, academic institutions, and regulatory investigators in immunology. Represent Biogen in external forums and scientific partnerships in broad immunology indications. Strong cultural alignment with WCH’s collaborative and solutions-driven approach, bringing curiosity, adaptability, and a bias for execution to complex challenges. Qualifications
The ideal candidate will have the following mix of professional and personal characteristics: Professional Qualifications MD, PhD, or PharmD required; subspecialty in immunology drug development strongly preferred. At least 15 years of relevant experience in clinical research, with a minimum of 10 years in the biopharmaceutical industry. Proven track record of leading successful clinical development programs from early to late stage; experience in IND submissions and global regulatory interactions preferred. Deep scientific and clinical understanding of nephrology and broad immune-mediated diseases. Demonstrated ability to work effectively with cross-functional R&D partners including research, translational science, clinical operations, and regulatory affairs. Experience as a Sponsor Representative in regulatory agency meetings, including preparation and presentation of briefing materials. Breadth of Immunology Expertise, with demonstrated leadership across multiple indications. Experience leading cross-functional teams and mentoring clinical development professionals. Strong strategic thinking and problem-solving skills, with the ability to navigate ambiguity and complexity. Excellent communication and executive presence; capable of interacting credibly with internal leadership, external partners, and regulatory agencies. Personal Characteristics Action-oriented and entrepreneurial mindset, with a demonstrated ability to thrive in dynamic, fast-paced environments; prior experience in start-up or high-growth settings is valued but not required. Purpose-driven leader with a passion for improving outcomes in underserved patient populations. Collaborative, self-aware, and comfortable leading through influence across a matrixed organization. High integrity, with a strong sense of accountability and urgency. Committed to the growth and success of team members, fostering a culture of inclusion, learning, and excellence. Enterprise-minded leader who considers organizational impact and cross-functional interdependencies in decision-making. Able to inspire confidence and trust internally and externally, including among KOLs and partners in the nephrology field. Additional Information The base compensation range for this role is: $335,000.00-$486,000.00 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. #J-18808-Ljbffr