Sight is precious, and every minute counts for Stargardt disease patients.
At Alkeus, we are on a mission to transform the treatment of Stargardt disease.
With our science, we are working to address the root cause of Stargardt disease for the very first time, and open new possibilities to treating a wide range of patients with degenerative eye disease.
We got here by forging a new path, by imagining a different way to develop a breakthrough precision medicine. Now we are poised to maximize the impact of our science by building a dynamic, patient-focused company.
Our mission is urgent, and our organization is growing rapidly to prepare for approval and launch. We are hiring for key roles across all functions.
Bringing gildeuretinol through approval and launch provides a potential lifeline to Stargardt patients and their families. For the Alkeus colleagues who make this happen, it will be a defining moment in their careers—and in their lives.
Join us and discover your future here.
Here are some of the specific positions we are hiring now:
-
Vice President, Marketing
Manager: Chief Operating Officer
Position Location: Cambridge, MA
Work Arrangement: On-Site
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Position Summary:
The Vice President of Marketing will be a key driver of our brand strategy, responsible for developing a brand plan and executing comprehensive marketing plans that align with our business objectives and resonate with our target audiences. This role requires a blend of strategic vision, hands-on execution, a deep understanding of biotech, rare and ophthalmology (Retina) specificities. The VP of Marketing will lead marketing strategies, collaborate closely with other departments to drive brand awareness, brand positioning, and product attribute communication.
Primary Responsibilities:
- Lead pre-commercialization marketing activities including brand planning and execution, patient identification and digital efforts
- Create a comprehensive marketing plan aligned with the company’s overall goals, including brand positioning, key messaging, and targeted audiences (patients, ECPs, caregivers, etc.)
- Partner with Medical Affairs and patient advocacy on ECP and patient educational initiatives
- Build relationships with KOLs, patient advocacy groups, and healthcare professionals
- Develop patient marketing strategies, plans and identified resources needed
- Develop brand positioning and marketing programs based on customer insights
- Partner with operational excellence and sales management teams
- Oversee the development and execution of multi-channel marketing campaigns across various platforms
- Understand and strictly apply US regulations and guidelines for marketing treatments for rare diseases. Contribute to an efficient and compliant medical and legal review process
- Partner with IT and agency to support gildeuretinol product launch
- Develop and manage the marketing budget, ensuring efficient allocation of resources
- Understand Stargardt genetic specificities to create relevant plans
- Partner with sales leadership to implement the brand strategy and develop impactful materials
- Establish clear objectives and key performance indicators (KPIs) to measure the success of marketing plan implementation
- Partner with legal and compliance to ensure the implementation of compliant messages and programs
Qualifications:
- Bachelor’s Degree required; MBA or another Advanced Degree preferred
- Minimum of 15 years of life sciences industry experience
- Extensive working knowledge of strategic and brand marketing and omni-channel approaches
- Prior collaboration with Key Opinion Leaders and investigators
- Visionary and innovative mindset with a passion for driving change and growth.
- Ability to thrive in a fast-paced, start-up environment with a hands-on approach.
- Proven track record of developing talent and being a culture champion
- Experience with key aspects of U.S. regulatory filings and launches
- Experience in competitive rare disease launch and commercialization in the U.S.
- Strong preference given to candidates with Retina/Ophthalmology.
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.
- 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
- Ability and aptitude to manage ambiguity and adaptability to change
- Emphasize the need for self-motivation and the ability to work independently
Other Relevant Information:
- Able to travel up to 30% of time
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to careers@alkeuspharma.com.
-
Human Resources Generalist
Manager: Senior Director, Human Resources
Position Location: Cambridge, MA
Work Arrangement: On-Site
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Position Summary:
The Human Resources Generalist will assist with the coordination of the day-to-day operations and communications of the Human Resources department. There will be a strong emphasis on recruitment systems and support, interview scheduling, onboarding and overall candidate experience. In addition, this individual will be responsible for benefits administration and processing, payroll support, compensation administration and HR Systems. This position requires a highly organized, detail-oriented, customer-focused individual who exercises a high level of professionalism and confidentiality in working with all levels of the organization. This is an exciting opportunity to explore and understand multiple facets of Human Resources, and to be at the forefront of our mission by making significant impact on the growth and direction of Alkeus Pharmaceuticals.
Primary Responsibilities:
- Demonstrate exemplary people skills and care for the process for each candidate ensuring a best-in-class candidate experience by working directly with candidates, recruiters and hiring managers to schedule interviews, greet and host candidates while on-site, and address any issues that arise.
- Serve as the first point of contact for employee questions and requests, escalating as appropriate, including, but not limited to actively managing the HR and Careers inboxes, directing and following up on inquiries as appropriate. Own onboarding logistics and facilitate HR Orientation.
- Maintain social media channels, job postings, and running the related reports for leadership teams.
- Support HR compliance matters, inclusive of employee trainings.
- Manage HRIS, ensuring accuracy and confidentiality.
- Working closely with Finance team members, support payroll and related activities.
- Actively manage and administer benefits.
- Support compensation administration.
- Maintain and update employee records, including personal information, job titles, and employment history. Bring an eye for continuous improvement to all People processes and programs and recommend changes or additions.
- Support other related projects as assigned.
Qualifications:
- Advanced degree preferred (i.e., MBA)
- Bachelor’s degree (preferably in science)
Work Experience:
- Bachelor’s degree strongly preferred.
- 2-4 years in a corporate professional business environment. HR experience preferred.
- Experience handling a wide range of administrative tasks preferably of a critical or confidential nature.
- Prior experience working with HRIS and ATS systems is preferred.
- Ability to work independently, think proactively and prioritize own work.
- Experience in a customer service-oriented role.
- Expert use of PowerPoint and Excel is essential.
- Experience multitasking on many projects at once with a strong ability to work in a fast-paced. environment and be able to switch gears and pick back up where they left off.
Skills and Key Success Factors:
- 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.
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to careers@alkeuspharma.com.
-
Senior Director, Clinical Development
Manager: Chief Medical Officer
Position Location: Cambridge, MA
Work Arrangement: On-Site
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Position Summary:
This role is instrumental in driving the successful development and launch of innovative therapies to address unmet medical needs. The Senior Director of Clinical Development will lead and oversee clinical development programs from early-stage trials through to regulatory approval, ensuring alignment with the company’s strategic objectives. The ideal candidate will bring experience in clinical trial design, execution, and regulatory interactions, with a particular focus on rare disease and small molecules.
Primary Responsibilities:
- Lead and mentor high-performing clinical development teams, fostering a culture of excellence and innovation
- Lead the design, implementation, and oversight of clinical development programs from Phase 1 to Pivotal studies
- Develop and manage clinical development strategies aligned with company goals and regulatory requirements
- Represent the company in interactions with regulatory agencies, including FDA, EMA, and PMDA
- Oversee the day-to-day medical monitoring of clinical trials, including patient eligibility assessments, protocol waivers, and safety parameter reviews
- Manage and coordinate with Clinical Research Organizations (CROs) throughout the clinical trial process
- Provide medical and scientific expertise to support clinical development activities
- Manage pharmacovigilance activities, including adverse event reporting and safety update reports
- Lead and mentor clinical development team members
- Contribute to the preparation of regulatory submissions, including INDs, NDAs, and other required documentation
- Collaborate with cross-functional teams to ensure alignment of clinical development plans with overall product strategy
Qualifications:
- MD or MD/PhD, with strong academic qualifications and board certification in Internal Medicine required
- Bachelor’s degree (preferably in science)
Preferred Qualifications:
- Ophthalmologist
Work Experience:
- 5+ years demonstrated clinical development experience in a pharmaceutical or biotechnology setting
- Knowledge of clinical development process and methods of scientific investigation, GCP, the FDA regulatory environment and guidelines, including study and protocol design
- Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies
- Demonstrate experience in clinical design and implementation of Phase 1 to Pivotal Clinical studies, with evidence direct leadership of trials that meet the timelines, budget, expected outcomes and lead to regulatory success of innovative medicines
- Sound medical/scientific writing skills and ability to analyze and interpret efficacy and safety data
- Direct experience in clinical development of small molecules
- Knowledge of statistical concepts as they relate to clinical plans
- Experience managing clinical CROs from RFP to statements of work to coordinating execution
- Knowledge of the day-to-day medical monitoring of clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).
- Knowledge in pharmacovigilance, including the receipt and processing of ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports
- Excellent problem solving, conflict resolution and team building
- Must demonstrate highly refined analytic and communication skills, and the ability to work effectively, both independently and in a team 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.
- 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.
- Ability and aptitude to manage ambiguity and adaptability to change.
- Emphasize the need for self-motivation and the ability to work independently.
Other Relevant Information:
- Able to travel up to 25% of time
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to careers@alkeuspharma.com.
-
Director of Strategic Planning
Manager: Chief Executive Officer
Position Location: Cambridge, MA
Work Arrangement: On-Site
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Position Summary:
The Director of Strategic Planning is responsible for spearheading strategic planning for the company. Initiatives will include long range planning, corporate strategy development, and ad hoc initiatives to support Executive Leadership. This is a high-profile position which provides the opportunity to work with senior leadership across the organization to shape the strategic direction of a growing company.
Primary Responsibilities:
- Lead the development of the company’s long-range plan, effectively articulating the company’s long-term corporate vision, strategy, and pro-forma financial implications
- Interface with executive and functional leadership to facilitate selected corporate planning processes, such as quarterly business reviews and functional planning
- Works closely with all functions to include G&A, Clinical Development, Regulatory Affairs, Manufacturing, Quality and Commercial teams
- Lead/support ad hoc internal strategic initiatives, such as internal corporate strategy or operational workstreams for the executive leadership team and other internal stakeholders
- Prepare and deliver key corporate presentations (including corporate/portfolio presentations, board materials, etc.)
- Support portfolio strategy efforts which may include disease area planning, business development opportunity assessment, program assessment and valuation
- Assist in building and scaling company operations as the organization grows
Qualifications:
- Advanced degree preferred (i.e., MBA)
- Bachelor’s degree (preferably in science)
Work Experience:
- At least 8 years of relevant work experience, including 2-4 years in a strategic consulting role, either for a strategy consulting firm or in-house for a pharmaceutical company
- Strong knowledge of the pharmaceutical business including drug development and commercialization
- Preferred experience in startup biotech environments
- Strong strategic thinking and problem-solving skills, including ability to develop strategic frameworks to facilitate decision-making around complex opportunities
- Strong analytical & financial modeling skills (product forecasts, P&L, NPV models, etc.)
- Experience leading and motivating cross-functional teams, and ability to deliver on project timelines, progress, and outcomes
- Excellent communications skills, in writing and orally, including presentation to senior executives and board
- Strong technology skills, including proficiency with data visualization tools (e.g., Tableau, Power BI), familiarity with project management software and knowledge of industry-specific databases and information sources
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.
- 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.
- Ability and aptitude to manage ambiguity and adaptability to change.
- Emphasize the need for self-motivation and the ability to work independently.
Other Relevant Information:
- Able to travel up to 25% of time
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to careers@alkeuspharma.com.
-
Associate Director, Quality Assurance Operations
Manager: Executive Director, Quality
Position Location: Cambridge, MA
Work Arrangement: On-Site
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Position Summary:
This role is instrumental in driving the successful development and launch of innovative therapies to address unmet medical needs. The Associate Director of QA Operations will lead the GMP QMS activities and oversight over the manufacturing, testing, and distribution of a small molecule drug, and directly support the transition to commercial drug product manufacturing and distribution. The ideal candidate will bring hands-on operational QA experience with GMP and GDP to our fast-paced collaborative environment.
Primary Responsibilities:
- Disposition of small molecule Drug Substance (API), Bulk Drug Product, and Finished Drug Product for release to forward processing or for distribution
- Review of CDMO batch records, Certificates of Analysis (CoA), and Certificates of Conformance to ensure all products and processes comply with the relevant specifications, regulations and guidance
- Review and approve specifications, CoAs for critical raw materials, small molecule GMP intermediates, API, Bulk and Finished clinical and commercial Drug Products
- Partner with Alkeus CMC and Supply Chain and with the QA/QC functions at CDMOs and Contract Labs to assess and mitigate risks and to ensure quality and GMP compliance throughout the product life-cycle
- Initiate and lead QMS processes to completion for Deviations, CAPA, Change Control, etc., working in partnership with the Alkeus CMC and Supply-Chain, and in collaboration with the CDMOs/CMOs/Labs
- Support OOS/OOT investigations and resolution in partnership with the Alkeus CMC group and with CDMOs/CMOs/Labs
- Development of GMP Governing Documents (Policies, SOPs, Work Instructions, Templates, Forms, etc.)
- Coordinate the GMP audit program including scheduling and tracking supplier audit execution and follow-up actions
- Perform internal and external GMP audits and compliance assessments
- Ensure compliance with FDA regulations and other relevant industry regulations, guidance and standards.
Leadership and Strategy:
- Lead the QA-operations function within the organization.
- Develop and implement quality strategies including transition from clinical to commercial manufacturing and distribution
- Gain expertise with the electronic quality management system (eQMS) and guide others in its use
- Support QA organization Development
- FDA Inspection-Readiness for GMP processes and activities
- This role involves maintaining high standards of quality, ensuring regulatory compliance, and driving continuous improvement in pharmaceutical QA operations.
Qualifications:
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biotechnology, etc.) or related field; advanced degree preferred.
- Minimum of 8-10 years of experience in QA within the pharmaceutical industry, with at least 3-5 years in a managerial role in clinical and commercial QA. Direct experience with small molecule oral dosage forms is a strong plus.
- In-depth knowledge of FDA regulatory requirements and industry standards for GMP and GDP
- Direct experience with virtual operations and Quality oversight of remote Vendors (CDMOs, QC Labs, Distributors, etc.) is required.
- Prior experience in, or partnering on the qualification of GMP facilities and equipment and the validation of Drug Substance and Drug Product is highly desirable.
- Prior experience in QC will be a valuable asset for this role.
- Excellent leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Strong leadership, collaboration, communication (verbal and written), and problem-solving skills are integral to this position.
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.
- 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.
- Ability and aptitude to manage ambiguity and adaptability to change.
- Emphasize the need for self-motivation and the ability to work independently.
Other Relevant Information:
- Occasional U.S. or International travel may be required.
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to careers@alkeuspharma.com.
-
Director of Clinical Quality
Manager: Head of Quality
Position Location: Cambridge, MA
Work Arrangement: On-Site
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Responsibilities:
- Manage the GCP Quality functional area, in compliance with US (FDA) and international regulations and Guidance, to ensure that the appropriate processes, systems and activities are in place to protect the rights, safety and welfare of clinical patients
- Provide quality oversight of internal and external clinical functions, ensuring that operations in the clinical functional areas are compliant with GCP, GLP, relevant Regulatory (FDA, etc.), and industry standards
- Act as a GCP Subject Matter Expert (SME) in GCP and GVP compliance on operations supporting clinical areas such as Clinical Operations, Pharmacovigilance, Data Management, etc.
- Support the drafting and implementation of the Alkeus GCP/GVP Quality Management System SOPs.
- Manage the planning and execution of clinical site and CRO/Vendor audits.
- Perform external and internal GCP audits and gap assessments (on-site and/or remote) on an as-need basis.
- Manage clinical site, CRO/Vendor, and internal CAPA closure for audit observations.
- Review of clinical and data management operational plans and protocols
- Review of key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA
- Participate in preparing for, hosting and supporting Health Authority/Regulatory inspections and internal/external audits.
- Serve as an SME for areas of responsibility during regulatory inspections, and directly lead and/or support inspection Ready-Room activities.
- Promote a culture of continuous improvement, and cross-functional problem-solving
- Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.
- Lead the development of internal and external Risk-Based Quality Assessments.
- Advise on the severity and processing of clinical protocol deviations
- Perform other duties as necessary, demonstrating flexibility and adaptability.
Qualifications:
- Bachelor’s or Master’s degree in a life science or healthcare field (Nursing, etc.) with 8 to10 years of GCP experience in drug and/or biopharma companies, or in a Contract Research Organization (CRO) capacity.
- Experience with small molecule drugs is a plus.
- Capacity to self-manage priorities and work independently while seeking guidance when necessary.
- Demonstrated knowledge of Quality Systems, GCP, and PV within an FDA and EMA-regulated environment. Able to handle multiple assignments in a fast-paced environment with changing priorities and to influence and work independently in a team environment.
- Strong verbal and written communication and collaboration skills, with the ability to work effectively across functional areas in a small, hands-on pharmaceutical start-up environment.
- Ability to apply compliance and risk-based thinking to quality assessments and problem-solving.
- Ability to influence change and process improvements internally and at clinical sites/CROs
- Demonstrated ability to train and mentor others in industry best practices.
Experience:
- 7+ years’ experience with Clinical Quality Systems in the drug or biopharmaceutical fields.
- At least 3 years of prior GCP auditing experience of clinical sites, CRO’s and Pharmacovigilance required, with the ability to audit independently, and deliver timely reports and assessments.
- Experience in implementation and maintenance of Clinical Quality Systems.
- Experience in training staff on GCP and GLP principles, processes and procedures.
- Broad hands-on experience in GCP/GVP quality and regulatory compliance.
- Excellent knowledge of FDA GCP/GVP Regulations and Guidance, ICH GCP/GVP Guidelines, EMA Directives and Regulations, and MHRA Regulations and Guidelines.
- Thorough understanding of clinical drug development processes.
- Auditing clinical study sites.
- Assessing compliance status for GCP/GVP databases, such as for clinical data (EDC), PV, and eTMF systems.
- Supporting inspection-readiness and Health/Regulatory Authority Inspections.
- Supporting the drafting, quality checks, and source data verification of regulatory submissions is beneficial.
- Experience in monitoring clinical site data is a plus
- Prior experience with Small Molecule oral drugs is a plus.
- Prior relevant experience at FDA (BIMO) as an investigator of Clinical Study Sites, Sponsors, GCP/GVP CROs and Clinical Labs is a plus
- Fluent in English, with proficiency in Microsoft applications (Excel, Word, SharePoint, PowerPoint).
Other Relevant Information:
- Willingness to travel, up to 20%, on an as-need basis for performance of CRO, Vendor or Clinical Site audits
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to careers@alkeuspharma.com.
-
Head of Supply Chain
Manager: VP, CMC & Technical Operations
Position Location: Cambridge, MA
Work Arrangement: On-Site
About Alkeus Pharmaceuticals:
Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy (GA) secondary to dry age-related macular degeneration. For additional information, please visit our website at www.alkeuspharma.com.
Position Summary:
The Head of Supply Chain is accountable for developing an end-to-end supply chain organization to ensure efficient delivery from manufacturing through distribution. The incumbent is responsible for developing and managing end-to-end supply chain processes, including Sales & Operations Planning, Logistics & Trade Compliance, Artwork/Labeling and Secondary Packaging, Serialization, and Distribution. This role is critical in the development and seamless execution of launch strategies and plans that drive commercial market readiness. Oversee all supply aspects of commercial launch readiness for Gildeuretinol (ALK-001) by collaborating across the organization with Commercial, Finance, Market Access/Trade, CMC, Quality and Regulatory.
Primary Responsibilities:
- Build capabilities in all key areas of Supply Chain – Plan/Source/Make/Deliver, including cold chain logistics, import/export compliance, and serialization
- Develop a Sales & Operations Planning process to ensure consensus and alignment between Supply Chain, Finance and Commercial on business objectives and supply plans
- Develop robust supply plan from raw material to drug substance to bulk drug product manufacturing and secondary packaging activities
- Conduct scenario plans to determine optimal supply strategy
- Ensure product readiness, partnering closely with external suppliers to address challenges and manage performance through thoughtful KPIs
- Collaborate with Procurement/Strategic Sourcing in negotiation of applicable contracts and develop supplier strategy; identify, evaluate, select and manage external partners
- Oversee risk management, proactively identifying risks and developing mitigation plans to prevent supply disruption
- Lead with a continuous improvement mindset to build a reliable and efficient supply chain organization
- Support CMC activities including regulatory submissions, inspections, and queries
Qualifications:
- Advanced degree with a minimum of 10 years of industry experience in a highly regulated pharma/biotech supply chain position
- Terminal level degree in life sciences or a related field (MD, PhD, or PharmD, OD, DO)
- Experienced in transitioning from clinical stage to commercial launch is highly preferred
- Experienced in design and implementation of electronic inventory systems, global serialization experience (EPCIS, Tracelink)
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.
- 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
- Ability and aptitude to manage ambiguity and adaptability to change
- Emphasize the need for self-motivation and the ability to work independently
Other Relevant Information:
- Travel: Up to 10%
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage candidates of all backgrounds to apply.
To apply, please submit your resume to careers@alkeuspharma.com.
-
General Interest
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 to careers@alkeuspharma.com for general consideration.
Don’t see a role that’s a match?
Not all available roles are listed above and we are currently hiring across all functions. We have multiple roles available in medical affairs, regulatory, commercial, manufacturing, clinical, legal, financial, human resources, and business development.
If you think you’d be a fit for Alkeus, we’d love to hear from you at: