Senior Medical Director, Clinical Development - Neurodegeneration
GSK
June 30, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Key Responsibilities:
- Lead clinical development strategy for drug/programs: accountable for clinical components of the Target Medicine Profile (TMP), lead the Clinical Matrix Team (CMT), and ensure comprehensive Clinical Development Plans (CDPs) and strategic oversight of clinical trials.
- Contribute to the Integrated Evidence Strategy (IES) by integrating scientific rationale, regulatory requirements, product plans, and commercial goals.
- Drive clinical development timelines for complex assets with decision points, risk/cost analyses, and Go/No Go criteria; lead PTRS Probability of Technical Success evaluations and risk-benefit assessments.
- Collaborate with Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics; serve as clinical point of contact for senior leadership, matrix teams, regulators, payors, CROs, consultants, and investigators.
- Lead global regulatory interactions; draft clinical components of submissions (IND, NDA, BLA, MAA) including briefing documents, presentations, and responses.
- Manage/mentor Clinical Development staff and drive innovative strategic initiatives and methodologies (including digital tools).
- Stay current on therapeutic area, trial methodologies, competitive and regulatory landscape.
Basic Qualifications:
- Medical degree and medical specialty board qualification/registration.
- Industry experience in Neurodegeneration; Alzheimer’s Dementia focus.
- Late-stage development experience (Phase 2/3 design, initiation, execution, closure).
- Experience leading NDA/BLA/MAA submissions and global neurodegenerative trials.
- Clinical research methodology and biostatistics principles.
- Matrix team leadership experience.
Preferred Qualifications:
- Neurology board qualification.
- Deep neurodegeneration/Alzheimer’s biology and therapeutic target knowledge.
- ICH/GCP knowledge; regulatory and reimbursement data requirements.
- Understanding of regulators, payers, prescribers; strong stakeholder relationships.
- Problem-solving/innovation; enterprise mindset; ability to evaluate complex data; navigate ambiguity.
On-site requirement: minimum two days/week in a US (PA or MA) GSK site.
Compensation/benefits (US): base salary $284,625–$474,375 (new hires in listed locations), annual bonus, and eligibility for long-term incentive; benefits include healthcare/insurance, retirement, paid holidays, vacation, and caregiver/parental/medical leave.
- Lead clinical development strategy for drug/programs: accountable for clinical components of the Target Medicine Profile (TMP), lead the Clinical Matrix Team (CMT), and ensure comprehensive Clinical Development Plans (CDPs) and strategic oversight of clinical trials.
- Contribute to the Integrated Evidence Strategy (IES) by integrating scientific rationale, regulatory requirements, product plans, and commercial goals.
- Drive clinical development timelines for complex assets with decision points, risk/cost analyses, and Go/No Go criteria; lead PTRS Probability of Technical Success evaluations and risk-benefit assessments.
- Collaborate with Commercial, Regulatory, Clinical Operations, Medical Affairs, and Statistics; serve as clinical point of contact for senior leadership, matrix teams, regulators, payors, CROs, consultants, and investigators.
- Lead global regulatory interactions; draft clinical components of submissions (IND, NDA, BLA, MAA) including briefing documents, presentations, and responses.
- Manage/mentor Clinical Development staff and drive innovative strategic initiatives and methodologies (including digital tools).
- Stay current on therapeutic area, trial methodologies, competitive and regulatory landscape.
Basic Qualifications:
- Medical degree and medical specialty board qualification/registration.
- Industry experience in Neurodegeneration; Alzheimer’s Dementia focus.
- Late-stage development experience (Phase 2/3 design, initiation, execution, closure).
- Experience leading NDA/BLA/MAA submissions and global neurodegenerative trials.
- Clinical research methodology and biostatistics principles.
- Matrix team leadership experience.
Preferred Qualifications:
- Neurology board qualification.
- Deep neurodegeneration/Alzheimer’s biology and therapeutic target knowledge.
- ICH/GCP knowledge; regulatory and reimbursement data requirements.
- Understanding of regulators, payers, prescribers; strong stakeholder relationships.
- Problem-solving/innovation; enterprise mindset; ability to evaluate complex data; navigate ambiguity.
On-site requirement: minimum two days/week in a US (PA or MA) GSK site.
Compensation/benefits (US): base salary $284,625–$474,375 (new hires in listed locations), annual bonus, and eligibility for long-term incentive; benefits include healthcare/insurance, retirement, paid holidays, vacation, and caregiver/parental/medical leave.