Senior Medical Director Global Clinical Development Oncology

Job description

Work Location: Billerica, Massachusetts Shift: No Department: HC-RD-OB Clinical Development Oncology 2 Recruiter: Shelby Elizabeth Briggs This information is for internals only. Please do not share outside of the organization. Your Role As a Senior Medical Director in Global Clinical Development Oncology, you will provide strategic, clinical, and scientific leadership for development programs in oncology. Your focus will be experience with drug development for solid tumors and ideally with experience in targeted therapies and antibody-drug conjugates (ADCs). Key Accountabilities: Lead and shape clinical development strategy across the development continuum, from Phase 1 through Phase III, including registration-enabling activities, regulatory submissions, dossier contributions, and Health Authority interactions. Provide senior medical leadership on study design, execution, data interpretation, and key development decisions to support the advancement of oncology programs. Guide indication strategy, patient selection, dose optimization, and overall development pathways Integrate clinical, translational, and biomarker data into program decision-making Oversee review and interpretation of safety and efficacy data to support development decisions Drive and review key clinical and regulatory documents, including development plans, protocols, investigator brochures, clinical study reports, briefing books, submission documents, and dossiers Lead or shape registration-enabling activities and regulatory submission strategy Lead or represent Clinical Development in interactions with Health Authorities and internal governance bodies, as appropriate. Serve as a senior leader within cross-functional and global teams, partnering closely with Program Leadership and Management, Translational Medicine, Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Pharmacology, Safety, and Medical Writing. Influence strategic direction, represent Clinical Development in key forums, and help ensure high-quality and timely delivery of development objectives in an office-based global environment. Partner effectively with cross-functional stakeholders across including Program Leadership and Management, Clinical Operations, Safety, Regulatory Affairs, Biostatistics, Clinical Pharmacology, Translational Medicine, and Medical Writing Provide strategic leadership within global matrix teams to ensure alignment, execution, and delivery against timelines Provide leadership and oversight to team members within Clinical development, as needed Contribute to business process improvement and organizational development initiatives, as appropriate. Who You Are Minimum Requirements: MD with expertise in clinical drug development Strong expertise in Oncology Minimum 5 years of industry experience in clinical R&D within pharma/biotech Experience leading or supporting clinical studies across Phase 1 through Phase III Experience contributing to clinical development strategy, registration-enabling activities, and regulatory submissions Familiarity with clinical dossiers, regulatory documentation, and interactions with Health Authorities Demonstrated ability to interpret and apply clinical, translational, and biomarker data to development decisions Experience leading cross-functional, matrixed, and international teams Familiarity with ICH-GCP, FDA and/or EMA expectations, and clinical trial regulations Excellent written and verbal communication skills in English Ability to work effectively in an office-based environment and across global time zones Preferred Requirements: Experience in targeted therapies, ADCs, immuno-oncology, and/or hematology/hematologic oncology Experience across early and late clinical development Experience with registration strategy and major regulatory submissions Experience engaging with Health Authorities and internal governance forums Experience with precision medicine, and/or biomarker-driven development Experience mentoring, guiding, or managing medical team members Strong strategic thinking, project leadership, and decision-making skills. Key Competencies Strong clinical and scientific judgment in oncology Strategic thinking and development leadership Ability to translate complex clinical and scientific data into development strategy Effective leadership in cross-functional and global matrix teams; team player mentality Clear and persuasive communication Ownership, accountability, and execution focus Comfort working in a fast-paced, global organization Location: Billerica, MA, USA; Onsite (Hybrid) Travel: Pay range for this position: $251,000.00 - $409,300.00 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.