Position Summary:

The Senior Director, Commercial Strategy lead is responsible for understanding the evolving needs of the Stargardt community and shaping the brand strategy, including the execution of comprehensive marketing plans. This role will lead brand planning, product launches, and lifecycle management, working closely with cross-functional teams across commercial, medical, regulatory, and clinical functions.

This is a leadership role on the commercial team that will own the go-to-market strategy, lifecycle planning, ensuring seamless collaboration across functions and support market access research ultimately driving meaningful patient impact and delivering strong business results.

Primary Responsibilities:

Brand Strategy & Tactical Execution:

• Develop integrated brand strategies and lifecycle activities to support differentiation and commercialization goals
• Drive disease area strategy, market segmentation, and product positioning based on unmet needs, competitive landscape, and evolving science
• Responsible for creating external (promotional/educational) communication materials for external use with customers (ECPs and Patients)
• Partner with Corporate Communications to support development of the Corp Communications tactics and messages as needed
• Lead the cross-functional workshops for the development of strategic and tactical plans for gildeuretinol

Competitive Strategy and Response:

• Assess emerging trends, market dynamics, and competitive activity to inform commercial decisions
• Lead competitive scenario planning and collaborate with medical, corp. comms, strategic planning and clinical to develop competitive response strategy
• Translate scientific and market insights from ECPs and patients (through market research, ad boards, etc.) into differentiated product strategy and value stories
• Evaluate strategic implications of evolving regulatory, pricing, and access landscapes globally
• Provide input into forecasting assumptions and evaluate ROI for activities
• Collaborate closely with regulatory, medical affairs, market access and corporate communications to ensure alignment of brand vision and execution

Program Team and key workstreams participation:

• Lead development/optimization of TPP
• Generate and communicate ECP/Patient insights to inform Program strategy
• Be the commercial voice on program team and inform decisions impacting commercialization
• Participate in the evidence generation, pubs planning and LCM strategy sub teams to represent the commercial POV

Qualifications:

• Education and Certification
• Advanced degree (MBA) in marketing/ business, or scientific degree preferred
• Requires 12+ years of experience or the equivalent combination of education and experience

• Skills and Key Success Factors:
  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

• Travel:  Able to travel up to 25% of time

Compensation

• Base Salary Range: $235K - $275K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 25% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

Position Summary:

The Project Management/Analytics Intern will support the design of project dashboards, populating details and running analyses to identify key trends. They will work closely with a cross functional team to develop and implement a KOL planning tracker and an information source map. They will conduct research on topics related to Stargardt disease, inclusive of competition landscape and generate summary reports of their findings for the cross functional stakeholders. As a member of the team, they will support with planning meeting agendas, tracking activities and circulating

Primary Responsibilities:

• Support project planning, dashboards and tracking, actively engaging with cross-functional teams
• Analyze data and present outputs to teams
• Conduct research, develop summaries and present findings to the team
• Support planning meetings and facilitating follow ups
• Deliver on other related projects as assigned

Qualifications:

• Education and Certification
  • Completed or enrolled in a degreed program
  • Graduate degree/program preferred

• Work Experience
  • Prior Marketing and/or Project Management experience preferred

• Skills and Key Success Factors:
  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values and ethical standards

Compensation

• Hourly Wage Range: $20-$30 with actual contingent upon several factors such as the selected candidate’s education/work experience/training, others

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Position Summary:

The Senior Clinical Scientist is responsible for providing scientific leadership and oversight for late-stage (Phase 3) clinical development programs in rare disease ophthalmology. This role plays a critical part in ensuring the scientific integrity, regulatory readiness, and successful execution of pivotal clinical trials intended to support global registration.

As a senior individual contributor, the Senior Clinical Scientist serves as a core scientific partner across clinical development, working closely with clinical operations, biostatistics, regulatory affairs, and safety to translate strategy into executable, high-quality Phase 3 studies. This role is well-suited for an experienced hire with demonstrated success in late-stage clinical development within rare disease and/or ophthalmology.

Primary Responsibilities:

• Provide scientific leadership for Phase 3 clinical trials, including contributions to overall clinical development strategy, study design, endpoint selection, and patient population definition, with a focus on rare disease and ophthalmology indications.
• Lead or co-lead the development of pivotal study protocols, informed consent forms, and key scientific sections of regulatory documents, ensuring alignment with global regulatory expectations (FDA, EMA, and other health authorities).
• Serve as the scientific point of contact for assigned programs, providing ongoing oversight throughout trial execution, including review of emerging data, identification of scientific risks, and interpretation of results.
• Partner closely with clinical operations to ensure Phase 3 trials are scientifically sound, operationally feasible, and executed in accordance with protocol, timelines, and quality standards.
• Collaborate with biostatistics and data management to support statistical analysis plans, data review activities, interim analyses (as applicable), and final interpretation of clinical outcomes.
• Contribute to and support regulatory interactions, including preparation of briefing documents, responses to information requests, and participation in meetings with health authorities as a scientific representative of the program.
• Lead or significantly contribute to the preparation of clinical study reports, integrated summaries, investigator brochures, external presentations, scientific content for regulatory submissions, publications, author responses to questions from health authorities and other stakeholders.
• Support safety monitoring activities, including review and interpretation of adverse events and safety data, participation in safety review meetings, and collaboration with pharmacovigilance to ensure appropriate benefit–risk assessment for late-stage programs.
• Provide scientific input into investigator meetings, site feasibility and selection activities, and key study communications to ensure consistency and clarity across global trial sites.
• Mentor junior clinical scientists and contribute to the development of best practices, processes, and standards appropriate for a Phase 3–stage organization.

Deliver on other related projects and initiatives as assigned, with flexibility to support evolving program needs in a growing biotechnology environment.

Qualifications:

• Education and Certification
  • Master’s or Ph.D. in a relevant scientific discipline required
• Work Experience
  • 6–10+ years of experience in pharmaceutical or biotechnology clinical development setting, experience in Ophthalmology a plus
  • Demonstrated experience supporting or leading Phase 3 clinical trials, including protocol development, data interpretation, and clinical study reporting
  • Prior experience in rare disease and/or ophthalmology drug development strongly preferred
  • Experience supporting regulatory interactions and late-stage clinical submissions (e.g., NDA/BLA/MAA components) highly desirable
  • Experience working in a cross-functional, matrixed environment typical of small to mid-sized biotech companies
• Skills and Key Success Factors:
  • Deep understanding of late-stage clinical development and the scientific and regulatory expectations for pivotal trials
  • Strong scientific judgment with the ability to independently assess data, identify risks, and propose solutions
  • Entrepreneurial mindset with comfort operating in a fast-paced, resource-conscious organization
  • Highly organized and detail-oriented, with a strong commitment to data quality, accuracy, and compliance
  • Excellent written and verbal communication skills, including the ability to clearly convey complex clinical data to internal and external stakeholders
  • Collaborative leadership style with proven ability to influence across disciplines without direct authority
  • Hands-on, proactive approach with a strong sense of accountability and urgency
  • Highest standards of professionalism, integrity, and ethical conduct

Other Relevant Information:

• Travel: Able to travel as assigned

Compensation

• Base Salary Range: $160K - $240K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: 15% - 20% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

Position Summary

The Clinical Trial Manager (CTM) is responsible for the execution, and oversight of global clinical trials, ensuring high-quality delivery in alignment with ICH-GCP, regulatory requirements, and corporate objectives. This role provides day-to-day operational management of CROs and vendors and contributes to the development of processes that support the growth of the Clinical Operations function. This position requires on site presence in the Alkeus office in Cambridge, MA.

Responsibilities

• Manage daily clinical trial operations for a global clinical trial across all trial phases (startup through closeout), ensuring adherence to timelines, budget, and quality standards.
• Coordinate cross-functional team activities, document review.
• Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
• Provide monitoring oversight, including participation in co-monitoring visits, reviewing monitoring reports, confirming follow-up on action items and escalating issues.
• Support start-up activities to help accelerate site activations
• Oversee site management and site engagement initiatives to maintain strong site relationships.
• Lead study-specific meetings, including internal team meetings, CRO/vendor meetings.
• Provide input on key study documents including protocols, ICFs, eCRFs, and operational plans, etc.
• Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.
• Support risk identification and mitigation planning efforts.
• Maintain inspection readiness and ensure compliance with SOPs and regulatory standards.
• Prepare regular study updates, presentations, and risk assessments for senior leadership.
• Contribute to process improvement initiatives, development of SOPs, and operational best practices for the Clinical Operations department.

Qualifications

• Bachelor’s degree in a scientific or health-related field required; Advanced degree preferred.
• Minimum 5 years managing clinical trials and 8+ years of industry experience.
• Experience managing outsourced global clinical trials across Phase I–III strongly preferred.
• Experience managing phase III trials is a must.
• Strong knowledge of ICH-GCP and global regulatory requirements.
• Experience in biotech/pharma environment required.
• Ability to manage multiple tasks in a fast-paced environment.

• Skills and Key Success Factors:
  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

• Travel:  As required

Compensation

• Base Salary Range: $140,000 - $160,000, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 15% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

We are seeking a people focused and accomplished leader to join our team as Vice President, Clinical Operations to lead and expand the company’s clinical operations capabilities supporting clinical programs in retinal diseases.  

Position Summary 

The Vice President, Clinical Operations role is a key leadership position responsible for the strategic planning, execution, and oversight of global clinical trials, with particular focus on Phase 3 and other late-stage studies. 

This individual plays a critical role in ensuring operational excellence across the clinical development portfolio, including the successful delivery of pivotal clinical trials supporting global regulatory filings. The Vice President will lead and mentor a clinical operations team, collaborate cross-functionally across the R&D organization, and oversee external partners to ensure clinical studies are executed efficiently, ethically, and in full compliance with regulatory standards and Good Clinical Practice (GCP). 

As a senior leader in R&D, this individual contributes to clinical development strategy and cross-functional planning while representing Clinical Operations internally with leadership and externally with investigators, CRO partners, and other clinical stakeholders. 

Primary Responsibilities 

• Develop clinical operations strategies and implementation plans, in partnership with internal and external stakeholders, to support the company’s clinical development goals. 

• Lead the planning, initiation, and execution of global clinical trials across multiple programs, with particular focus on Phase 3 and other pivotal studies. 

• Build and lead a high performing clinical operations organization, mentoring team members and fostering a collaborative and accountable culture. 

• Lead relationships with external partners including CROs, central laboratories, and other vendors, ensuring effective vendor selection, governance, and performance management. 

• Ensure the successful operational execution of clinical studies in accordance with study protocols, timelines, budgets, and regulatory requirements. 

• Collaborate closely with Clinical Development leadership to translate clinical strategy into operationally feasible study designs and execution plans. 

• Participate in cross-functional teams for assigned programs, partnering with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Safety, and Medical Affairs to achieve high-quality study execution. 

• Ensure compliance with global regulatory standards and guidelines governing clinical trials, including Good Clinical Practice (GCP). 

• Provide operational input into clinical study protocols, feasibility assessments, site selection strategies, and patient recruitment and retention plans. 

• Oversee clinical trial budgets and resource planning, ensuring efficient utilization of resources and alignment with company priorities. 

• Identify operational risks and implement mitigation strategies to ensure timely trial execution and data quality. 

• Support regulatory submissions and inspections by ensuring operational documentation and trial conduct meet regulatory expectations. 

• Present clinical operations strategies, study progress, and operational updates to senior leadership and other stakeholders. 

• Deliver on other related projects as assigned. 

Qualifications 

• Education and Certification:  

• Bachelor's degree in a scientific or healthcare related field; advance degree preferred. 

• Work Experience 

• 12+ years of experience in clinical research and clinical operations within the pharmaceutical or biotechnology industry. 

• Demonstrated leadership in global clinical trial execution, including operational oversight of Phase 3 or other pivotal trials. 

• Proven track record of leading clinical operations teams and managing complex global clinical programs. 

• Extensive experience managing CRO partnerships and other external vendors supporting clinical trials. 

• Strong knowledge of global regulatory requirements governing clinical trials, including Good Clinical Practice (GCP). 

• Experience supporting regulatory submissions and inspections related to clinical trials. 

• Experience contributing to clinical development plans and cross-functional program strategy. 

• Experience in rare disease and/or ophthalmology drug development preferred.  

• Ability to adapt to changing circumstances and industry trends. 

• Significant experience in leading and managing clinical operations teams. 

• Skills and Key Success Factors:
  • Entrepreneurship spirit with a passion to build, learn and evolve with the team
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information:

• Travel: able to travel up to 35% of time 

Compensation

• Base Salary Range: $300K - $320K, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 30% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

We are looking for enthusiastic professionals who want to be at the forefront of our mission and make a significant impact on the growth and direction of Alkeus Pharmaceuticals.

We invite you to apply and submit your resume for general consideration.

#LI-DNI