Alkeus Pharmaceuticals, Inc. · 5 hours ago
Vice President, Clinical Development
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$310K/yr - $390K/yr
5+ years expAlkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on developing innovative therapies for serious eye diseases. The Vice President, Clinical Development will lead and expand the company’s clinical programs in retinal diseases, overseeing strategic planning, execution, and regulatory compliance while mentoring a team of professionals.
BiotechnologyMedicalMedical DevicePharmaceutical
Responsibilities
Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the company’s strategic and operational goals
Lead assigned clinical development team members across multiple clinical programs
Oversee the review, analysis and interpretation of clinical trial data and the reporting of clinical trial results, including preparation of abstracts, presentations, and manuscripts
As a senior leader in R&D, contribute to corporate strategy, investor relations, and business development initiatives
Lead interactions with KOLs, advisory boards, and external stakeholders to guide study designs and development plans
Participate in cross-functional teams, as needed, for assigned trials, collaborating with other team members to achieve efficient, high-quality study execution
Provide input on regulatory strategies, reviewing, and approving where necessary, regulatory documents for submission to multiple regulatory agencies for the various clinical programs
Lead interactions with academic thought leaders, investigators, cooperative groups, pharmaceutical partners/sponsors, patient advocacy groups, and other clinical stakeholders, developing relationships in support of clinical programs. Furthermore, engage in scientific and medical exchanges and identify unmet medical needs and gaps
Ensure appropriate management and oversight of clinical studies in partnership with clinical operations leadership. This includes, but is not limited to, the development of clinical study protocols; contribute to the selection and management of external partners such as CROs and other vendors; provide input on site selection for studies, study management, medical monitoring, clinical study reports, investigators brochures, regulatory briefing documents, and clinical sections of regulatory filings
Support clinical study teams, monitoring the overall study integrity, and reviewing, interpreting, and communicating accumulated data pertaining to safety and efficacy of the molecule
Present at scientific, medical, and regulatory meetings globally
Manage assigned budget, ensuring efficient resource utilization and investment in the areas of highest impact
Deliver on other related projects as assigned
Qualification
Required
Advance degree required; MD, MD/PhD, or equivalent a plus; specialty training or experience in Ophthalmology is preferred
5+ years of clinical development experience in the biopharmaceutical industry, with an emphasis on Ophthalmology and retinal diseases preferred
A proven success record of leading new medicines through all stages of clinical development to approval a plus
Must have excellent leadership and interpersonal skills; should have proven skills as an effective collaborator who can engender credibility and confidence within and outside the company; must have outstanding executive presence
The successful candidate will possess excellent communication and presentation skills demonstrating the ability to articulate the Company's clinical and regulatory strategies and progress to a wide audience, including senior management, the Board of Directors, Company employees and external stakeholders
Collaborative mindset with strong interpersonal skills to drive cross-functional success
Entrepreneurial 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 people-first leader, a team-player and collaborator in small working environments
Highest levels of professionalism, confidence, personal values, and ethical standards
Preferred
Subspecialty training or deep experience in retina preferred
Late-stage development experience with designing, setting up, reading out, closing and filling phase 3 trials is preferred
Proven leadership in designing and executing successful global clinical programs, including experience with pivotal/registrational trials with experience in rare disease drug development preferred
Experience with, or strong knowledge of orphan or rare disease drug development preferred or experience or knowledge of ophthalmology drug development a plus
Successful history of regulatory interactions and submissions (e.g., IND, NDA/BLA, Fast Track, Breakthrough Therapy)
Experience in early- and late-stage development (Phase I–III), ideally in both small and large molecules, gene therapy, or biologics targeting retinal disease
Previous experience coordinating with commercial and marketing teams to support efforts, including medical expertise and collaboration to strengthen a successful product launch
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
Company
Alkeus Pharmaceuticals, Inc.
Alkeus Pharmaceuticals, Inc.
51-200 employees
H1B Sponsorship
Alkeus Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
Funding
Current Stage
Growth StageTotal Funding
$150.1MKey Investors
Bain Capital Life Sciences
2023-06-05Series B· $150M
2011-10-24Grant· $0.1M
Leadership Team
Michel Dahan
President and CEO
Ilyas Washington
Co-Founder
Recent News
Company data provided by crunchbase