Clinical Development Lead, Transplant Expansion / New Indications

Biogen • San Francisco, CA

136d • $212,000 - $369,000

About The Position

The Biogen West Coast Hub (WCH) is 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 for transplant recipients, we are seeking a highly motivated and experienced Clinical Development Lead for our expansion beyond our ongoing Phase 3 trial in late antibody-mediated rejection. The successful hire candidate will embed strategic principles into all aspects of Clinical Development, ensuring plans increase the probability of technical and regulatory success. Activities include developing a framework for new indications, assessing regulatory and relevant policies that could accelerate drug development timelines, designing clinical studies, and interpreting study data while fully collaborating and leveraging the synergies of our ongoing pivotal program. The successful candidate will initiate and drive complex projects from strategy to value realization, including creating a framework for accelerating clinical development plans for each new transplant indication in our lead asset. This requires collaboration with cross-functional teams, subject matter experts, and other relevant stakeholders internally and externally, including the patient and scientific community, as well as global regulatory authorities.

Requirements

• MD and/or PhD degree required, with board certification in nephrology, immunology, or similar field.
• At least ten (10) years of overall relevant experience within pharmaceutical/biotech industry and clinical research is required.
• Clinical drug development experience is essential, including experience in late-stage drug development, with a preference for experience in transplant, nephrology and/or immuno-inflammatory indications.
• Extensive knowledge of basic, translational, and clinical science, broad understanding of the transplant, immunological and/or rare disease areas.
• Demonstrated dynamic leadership and team-oriented skills as well as perform effectively in an adaptive environment.
• Scientifically and clinically astute with strong learning agility and demonstrated ability to optimize development strategies and advance.
• Strong interpersonal skills, with the ability to establish and maintain relationships with key opinion leaders, clinical investigators, and internal stakeholders 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.

Responsibilities

• Represent the Biogen West Coast Hub Development team and influence decision-making in relevant governance and strategic forums.
• Identify additional transplant indications for our lead asset, differentiating it from current market competitors.
• Build and strengthen relationships with internal and external stakeholders, gathering expert feedback to develop life cycle management frameworks.
• Employ innovative approaches for rare disease drug development and real-world evidence to expedite development timelines.
• Coordinate with study team members to develop well-structured protocols for additional indications.
• Serve as subject matter expert on the safety reviews of our transplant programs.
• Support regulatory filings, addressing inquiries efficiently and effectively.
• Support internal and external clinical translational studies in close collaboration with Biomarker and Immunology Research teams.
• Present at investigator meetings, ensuring global study execution consistency.
• Present compelling data at international meetings and publish findings in respected scientific journals.
• Contribute to data analysis, scenario planning, and communicate study readouts with clarity.
• Integrate scientific rationale with regulatory, payor requirements, and commercial goals for each clinical development plan.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees