<p> </p><p><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">Work Location: Billerica, Massachusetts<br>Shift: No<br>Department: HC-RD-OC Clinical Development Immunology<br>Recruiter: Omar de Bary</span></span></p><p><br><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>This information is for internals only. Please do not share outside of the organization.</strong></span></span></p><p> </p><br><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Your Role:</span></strong></p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Responsibilities include but are not limited to:</span></p><ul style="margin-top: 0.0cm; margin-bottom: 0.0cm;" type="disc"><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Provide medical leadership across rheumatology/immunology clinical development programs, ensuring scientific rigor and patient-centric development.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Lead clinical development planning and contribute to target product profile, indication strategy, and evidence generation plans.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Drive protocol development and medical oversight through execution (population, endpoints, dosing rationale, safety monitoring, biomarkers as applicable).</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Lead governance preparation and decision-making, documenting recommendations, rationale, key risks, and mitigation/contingency plans.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Partner cross-functionally (Clinical Operations, Safety, Biostats, Regulatory, Quality, Medical Affairs, Business Franchise) to ensure integrated strategy and high-quality delivery.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Support regulatory submissions and interactions (briefing packages, responses, meeting participation) as medical lead.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Interpret clinical data and communicate results via CSRs, publications, congress materials, and internal updates.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Engage external experts (investigators/KOLs) compliantly to inform scientific strategy and study design.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Provide matrix leadership and mentoring; may manage direct reports depending on organizational needs.</span><span style="font-size: 10.0pt; line-height: 115%; font-family: Verdana, sans-serif;"> </span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Matrix leadership across global cross-functional teams.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Talent development: mentoring and coaching Clinical Scientists/medical staff; direct reports may be included based on organization needs.</span></li></ul><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Who You Are:</span></strong></p><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Minimum Qualifications:</span></strong></p><ul style="margin-top: 0.0cm; margin-bottom: 0.0cm;" type="disc"><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Medical Degree (MD) or international equivalent</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Board Certification in Rheumatology and/or Clinical Immunology and/or advanced degree (MD/PhD)</span></li></ul><p style="margin: 0.0cm 0.0cm 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><strong><span style="font-family: Verdana, sans-serif;">Preferred Qualifications:</span></strong></p><ul style="margin-top: 0.0cm; margin-bottom: 0.0cm;" type="disc"><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Significant clinical experience in Rheumatology and/or Clinical Immunology (typically 5–7+ years), including prior hands-on patient care</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">5+ years medical leadership in pharmaceutical/biotech clinical development, including regulatory submissions and interactions (FDA/EMA/others)</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Experience designing clinical development plans and leading global clinical trial execution in a matrix environment</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Strong track record of delivering milestones under tight timelines</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Deep knowledge of drug development and clinical trial methodology in immune-mediated inflammatory diseases/rheumatology</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Strong understanding of GCP, ICH, FDA/EMA requirements</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Sound clinical judgment and ability to make decisions with incomplete/ambiguous data; clearly communicates rationale and trade-offs</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Excellent cross-functional leadership, stakeholder management, and influence without authority</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Strong medical writing and document review skills (protocols, IBs, CSRs, briefing books)</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Excellent communication and presentation skills for governance and external forums</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Willingness to travel as needed (domestic/international)</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Ability to work at a computer for extended periods (reading/writing/reviewing documents, virtual meetings).</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Ability to communicate effectively verbally and in writing.</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Ability to travel as required (including navigating airports/hotels/sites).</span></li><li style="margin-top: 0.0cm; margin-right: 0.0cm; margin-bottom: 8.0pt; line-height: 115%; font-size: 12.0pt; font-family: Aptos, sans-serif;"><span style="font-family: Verdana, sans-serif;">Ability to attend in-person and virtual meetings, including occasional early/late meetings across time zones.</span></li></ul><p style="margin-top: 0cm;margin-right: 0cm;margin-bottom: 8pt;line-height: 115%;font-size: 12pt;font-family: Aptos, sans-serif;"> </p><p>Pay Range for this position: $229,800 - $381,700 </p><p>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 <span style="-webkit-tap-highlight-color: rgba(0, 0, 0, 0); text-size-adjust: none; text-decoration: underline;"><a href="https://careers.emdgroup.com/us/en/benefits" data-di-id="di-id-429ae2a6-dfbcce8d">here</a></span>.</p><br><p style="text-align:justify"> </p><p style="text-align:justify"><span style="font-size:12.0px"><span style="font-family:Verdana, Geneva, sans-serif">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.</span></span></p><p style="text-align:justify"> </p>
Originally posted by EMD Group. View original posting
BioCareerAI is an independent job platform and is not affiliated with or endorsed by EMD Group.