Associate Medical Director, Rare Hematology
Sanofi
Executive Medical Director, Clinical Development, Advanced Pipeline Unit – Respiratory
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Upper Providence • Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Go
About the role
- Lead the clinical development strategy from a drug or program including accountability for the clinical components of the Target Medicine Profile (TMP) and leadership of the clinical matrix team (CMT).
- Ensure cohesive and comprehensive clinical development plans (CDP) for product(s) and/or indication(s) and provide strategic oversight and management of clinical trials.
- Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
- Contribute to development of the Integrated Evidence Strategy (IES), including oversight of the CDP and its component clinical trials.
- Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and programs.
- Drive clinical development timelines for complex assets with clear decision points, risk/cost analyses, and Go/No Go criteria.
- Lead probability of technical success PTRS evaluations and assess study/project risk-benefit, implementing mitigation strategies as needed.
- Foster collaboration with Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics teams.
- Act as the clinical point of contact for senior management, matrix teams, and external stakeholders, including regulators, payors, CROs, consultants, and investigators.
- Lead clinical development discussions and teams at global regulatory interactions.
- Draft clinical components of global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
- Manage technical and leadership development of Clinical Development staff via direct line management, mentoring and coaching across the organisation.
- Drive strategic initiatives, business development activities, and organizational initiatives in Clinical Development.
- Promote innovative methodologies and processes including digital tools, encouraging others to think differently and adopt new ways of working.
- Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK’s competitive edge.
Requirements
- Medical degree and clinical medical specialty training board qualification/registration.
- Experience in the global pharmaceutical/biotechnology industry in the field of Interstitial Lung Diseases.
- Experience in Idiopathic pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF) and autoimmune associated ILDs including connective tissue disease Associated ILD (CTD-ILD).
- Experience in clinical research and drug development, with a focus on Interstitial Lung Diseases.
- Experience in late-stage Lung Disease drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure.
- Experience in leading NDA, BLA, or MAA submissions and managing global clinical trials.
- Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules.
- Line-management experience overseeing medical directors and/or clinical scientists as well as leading matrix teams within a clinical development setting.
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical development strategyclinical trials managementclinical development plansregulatory submissionsclinical research methodologybiostatisticsPhase 2 clinical trial designPhase 3 clinical trial designrisk-benefit assessmentprobability of technical success evaluations
Soft skills
leadershipcollaborationmentoringcoachingstrategic oversightcommunicationdecision-makingorganizational initiativesinnovation promotionteam management
Certifications
medical degreeclinical medical specialty training board qualification
