Work Location: Billerica, Massachusetts
Shift: No
Department: HC-RD-OC Clinical Development Immunology
Recruiter: Omar de Bary
This information is for internals only. Please do not share outside of the organization.
Your Role:
Responsibilities include but are not limited to:
- Provide medical leadership across rheumatology/immunology clinical development programs, ensuring scientific rigor and patient-centric development.
- Lead clinical development planning and contribute to target product profile, indication strategy, and evidence generation plans.
- Drive protocol development and medical oversight through execution (population, endpoints, dosing rationale, safety monitoring, biomarkers as applicable).
- Lead governance preparation and decision-making, documenting recommendations, rationale, key risks, and mitigation/contingency plans.
- Partner cross-functionally (Clinical Operations, Safety, Biostats, Regulatory, Quality, Medical Affairs, Business Franchise) to ensure integrated strategy and high-quality delivery.
- Support regulatory submissions and interactions (briefing packages, responses, meeting participation) as medical lead.
- Interpret clinical data and communicate results via CSRs, publications, congress materials, and internal updates.
- Engage external experts (investigators/KOLs) compliantly to inform scientific strategy and study design.
- Provide matrix leadership and mentoring; may manage direct reports depending on organizational needs.
- Matrix leadership across global cross-functional teams.
- Talent development: mentoring and coaching Clinical Scientists/medical staff; direct reports may be included based on organization needs.
Who You Are:
Minimum Qualifications:
- Medical Degree (MD) or international equivalent
- Board Certification in Rheumatology and/or Clinical Immunology and/or advanced degree (MD/PhD)
Preferred Qualifications:
- Significant clinical experience in Rheumatology and/or Clinical Immunology (typically 5-7+ years), including prior hands-on patient care
- 5+ years medical leadership in pharmaceutical/biotech clinical development, including regulatory submissions and interactions (FDA/EMA/others)
- Experience designing clinical development plans and leading global clinical trial execution in a matrix environment
- Strong track record of delivering milestones under tight timelines
- Deep knowledge of drug development and clinical trial methodology in immune-mediated inflammatory diseases/rheumatology
- Strong understanding of GCP, ICH, FDA/EMA requirements
- Sound clinical judgment and ability to make decisions with incomplete/ambiguous data; clearly communicates rationale and trade-offs
- Excellent cross-functional leadership, stakeholder management, and influence without authority
- Strong medical writing and document review skills (protocols, IBs, CSRs, briefing books)
- Excellent communication and presentation skills for governance and external forums
- Willingness to travel as needed (domestic/international)
- Ability to work at a computer for extended periods (reading/writing/reviewing documents, virtual meetings).
- Ability to communicate effectively verbally and in writing.
- Ability to travel as required (including navigating airports/hotels/sites).
- Ability to attend in-person and virtual meetings, including occasional early/late meetings across time zones.
Pay Range for this position: $229,800 - $381,700
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.