Executive Director Study Start-Up Job at Amgen (Cambridge)

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Executive Director, Study Start-Up

In this vital role as Executive Director, Study Start-Up (SSU), you will lead SS...

Location

United States , Thousand Oaks

Salary:

281634.00 - 336501.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of clinical execution experience
Master’s degree and 10 years of clinical execution experience
Bachelor’s degree and 12 years of clinical execution experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
12+ years’ work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making
ability to escalate and resolve challenges in alignment with global study strategy priorities
Extensive knowledge of the clinical and pharmaceutical drug development process, from early to late-stage development with a deep understanding of relevant therapeutic areas to meet the highest scientific and regulatory standards

Job Responsibility

Shape the long-term vision and strategy of the SSU Hub, ensuring alignment with CPSO, GDO, and enterprise priorities
Integrate and harmonize strategies from the six sub-functions into a single global capability strategy, balancing standardization with local/regional adaptability
Act as the global escalation point for study start-up risks and issues, ensuring timely resolution and portfolio-level visibility
Embed within the industry - bringing outside ways of working and representing Amgen back into the industry
Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence
Lead, and mentor the global SSU Hub leadership team, ensuring robust succession planning, talent development, and organizational effectiveness
Drive consistent performance management, alignment, and calibration across sub-functions to ensure equitable resourcing and delivery
Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally
Oversee start-up planning and execution across all new studies globally, ensuring timelines and quality standards are consistently achieved
Partner with Clinical Program Strategy and Operations TA Heads to ensure seamless integration of start-up into program execution

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Medical Director, Clinical Development – Dermatology

We are seeking a Medical Director to support clinical execution and medical moni...

Location

United States

Salary:

270000.00 - 310000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MD is required
Dermatologist strongly preferred
Experience in clinical development and/or study design and execution within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
2+ years’ pharma/biotech clinical development or medical affairs with study execution experience preferred
Experience working on phase 2 and 3 clinical studies strongly preferred

Job Responsibility

Serve as a primary Sponsor medical representative for assigned clinical trial
Contribute to protocol development, study documents, operational plans, and other relevant documents for individual studies
Support all the start-up activities related to the assigned Dermatology clinical study including investigator training, vendor discussions, cross-functional team reviews
Oversee day-to-day clinical and medical execution of studies including direct medical review of eligibility, safety events, and clinical data
Work closely with cross-functional colleagues to ensure timely and flawless execution of clinical plan and study milestones
Partner with clinical operations on site selection, recruitment, site relationship management and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Medical Director, Clinical Development - Dermatology/Immunology

We are seeking a Medical Director to oversee clinical execution and medical moni...

Location

United States

Salary:

280000.00 - 325000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MD is required
Experience in clinical development within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
2+ years’ industry experience as a medical monitor and/or medical director
Experience working on phase 2 and 3 clinical studies required
Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others
Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability to travel approximately 20% to All Team meetings, functional meetings, study-related activities, and medical conferences

Job Responsibility

Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
Support the design of trials and develop protocols and other relevant documents for individual studies
Support all the start-up activities related to the assigned dermatology clinical study
Oversee day-to-day clinical and medical execution of studies
Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
Partner with clinical operations on site selection, recruitment, and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Director, Data Management

The Associate Director / Director of Data Management is responsible for providin...

Location

United States , San Mateo

Salary:

Not provided

Dompé

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related discipline
12+ years of progressive experience in clinical data management, with at least 5 years in a leadership or oversight capacity
Extensive experience with Medidata products (Rave EDC, RTSM, Coder, integrations)
Proven ability to oversee multiple global studies and CROs concurrently
Deep understanding of clinical data management processes, data standards (CDASH, CDISC), and technology landscape
Experience in authoring and implementing SOPs, WIs, and operational best practices
Demonstrated success in supporting regulatory submissions (NDA, BLA, MAA) and managing inspection readiness
Strong leadership, problem-solving, and decision-making skills with the ability to operate independently
Excellent communication, organizational, and stakeholder management skills
Experience with budget forecasting, cost tracking, and resource planning for multi-study portfolios

Job Responsibility

Strategic Leadership & Oversight: Lead data management strategy across multiple studies and programs, ensuring alignment with corporate and regulatory objectives
Oversee CROs and external partners to ensure consistent quality, compliance, and timely delivery of study data
Act as the primary point of contact for data management oversight, providing direction, decision-making, and escalation management
Ensure study-level data standards, quality metrics, and processes are defined and consistently applied
Operational Excellence Across Study Lifecycle: Manage all data management activities from study start-up through database lock and close-out
Oversee development and execution of Data Management Plans (DMPs), edit check specifications, external data transfer agreements, and data validation activities
Ensure data collection systems, workflows, and integrations align with protocol requirements and regulatory expectations
Provide oversight for database design, User Acceptance Testing (UAT), and database release readiness
CRO & Vendor Management: Lead governance and performance management of CROs supporting data management functions
Review and approve study deliverables (CRFs, DMPs, edit checks, transfer specs, listings, and reconciliation plans)

Director, Clinical Scientist

The Director, Clinical Scientist is a senior, hands-on scientific leader respons...

Location

United States , Waltham

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of extensive hands-on experience supporting clinical trials in a clinical development role
Demonstrated experience reviewing and interpreting clinical trial data listings
Strong understanding of clinical trial conduct and cross-functional trial workflows
Proven ability to partner effectively with Clinical Operations
Exceptional organizational, prioritization, and execution skills
Strong written and verbal communication skills
Advanced PowerPoint skills
working knowledge of Excel and other commonly used clinical systems/tools
Ability to manage multiple studies and deadlines in a fast-paced environment
Advanced degree in life sciences discipline (PhD, PharmD, MS, or equivalent)

Job Responsibility

Support the Medical lead for one or more Phase I–III clinical studies
Support studies across the full trial lifecycle, from start-up through database lock and reporting
Lead ongoing review of clinical trial data listings, including adverse events, laboratory data, concomitant medications, vitals, ECGs, and safety outputs
Identify data trends, inconsistencies, and potential issues
partner with Data Management, Biostatistics, and Safety to resolve them
Act as a close scientific partner to Clinical Operations to deliver on trial execution
Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
Develop and deliver clear, well-structured presentations to study teams and internal leadership
Drive execution, follow-through, and accountability across multiple concurrent deliverables

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Senior Medical Director, Clinical Development

Cabaletta is seeking an experienced, highly motivated hands-on physician leader ...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

D., M.D./Ph.D. degree or equivalent required
Board Certification, Board Eligibility, or clinical experience in the field of Rheumatology and/or Immunology highly desirable
7+ years of experience in clinical research, including the design and execution of complex clinical trials, with a pharmaceutical or biotech company
Experience with or exposure to the development of adoptive cell therapies or biologic therapies is desirable
Experience with Health Authority interactions and submission of clinical regulatory documents is desirable
Strong written and verbal communication skills
ability to easily engage with investigators and key external experts
and ability to effectively present at conferences, advisory meetings, and other public for a
Engaged, hands-on, independent, and goal-oriented mentality
willingness to work in highly dynamic work environment

Job Responsibility

Provide medical leadership for various programs from first-in-human studies through registrational studies
Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities
Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities
Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings
Actively contribute during Health Authority interactions
Review available preclinical data that could inform the design of future clinical trials
Present at site evaluation and site initiation visits as applicable
In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data

What we offer

health and retirement, PTO, and stock option plans

Director, Global Supply Chain

The Director, Global Supply Chain reports to the Senior Director, Global Supply ...

Location

United States , Waltham, MA or San Diego, CA

Salary:

175000.00 - 230000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
8+ years of experience in clinical supply management
Experience with global pharmaceutical development and manufacturing operations for development-stage and/or commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
Deep understanding of IRT systems
Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
Strong computer skills including MS Office
Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
Ability to think outside of the box and challenge the status quo
Desire to work in a fast-paced, innovative environment
Domestic or international travel is required (up to 20%)

Job Responsibility

Managing drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
Providing day-to-day oversight of packaging and labeling/distribution vendors, including relationship management
Contributing to the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify management in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)

What we offer

comprehensive health coverage
flexible time off
paid holidays
a year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Executive Director Study Start-Up

Amgen

Location:
United Kingdom , Cambridge ▼
London
Uxbridge

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 06, 2026

Expiration:
February 12, 2026

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