Bria Gaber

Senior Director, Regulatory Advertising & Promotion Location: Remote, US (East and Central Time Zones) Industry: Biotechnology / Rare Disease A global biopharmaceutical organization is seeking an experienced Regulatory Advertising & Promotion leader to oversee its Ad/Promo function and provide strategic regulatory leadership across promotional, medical, and corporate communications. This highly visible role will lead an established team while partnering closely with Commercial, Medical, Legal, Regulatory, and senior leadership. Key Responsibilities Lead and provide strategic direction to the Regulatory Ad/Promo team . Own and evolve the global material review process across promotional and non-promotional communications. Provide strategic, risk-based regulatory guidance on promotional activities and product communications. Oversee regulatory review and approval of US promotional, corporate, and medical materials. Lead interactions with FDA OPDP/APLB , including proactive engagement and regulatory inquiries. Serve as regulatory lead on review committees and escalation discussions. Partner cross-functionally to balance business objectives with regulatory requirements. Develop and enhance SOPs, work instructions, and review processes. Qualifications 15+ years of pharmaceutical/biopharmaceutical industry experience, including 5+ years in Regulatory Advertising & Promotion . Deep knowledge of FDA promotional regulations, guidance, and evidentiary standards supporting product claims . Significant promotional and medical review experience. Experience interacting directly with FDA OPDP/APLB . Proven people leadership and cross-functional stakeholder management. Strong judgment and ability to navigate regulatory gray areas through thoughtful risk assessment and mitigation . BS in a scientific discipline required; advanced scientific degree or JD preferred. Rare Disease, Hematology, and/or Oncology experience is a plus. Experience with AI and digital tools is advantageous. Ideal Profile Seeking a collaborative, solutions-oriented Ad/Promo leader who combines deep regulatory expertise with strong business judgment. The ideal candidate can lead autonomously, influence senior stakeholders, develop an experienced team, and provide practical regulatory solutions rather than simply identifying risk.

Senior Director, Business Development Boston, Massachusetts About the Opportunity A clinical-stage biotechnology company is seeking an accomplished Senior Director, Business Development to join its growing global organization. This is a highly visible, externally facing role focused primarily on asset-level business development and out-licensing across a growing portfolio of preclinical and clinical-stage therapeutics. The successful candidate will identify and originate new partnering opportunities, develop relationships across the pharmaceutical and biotechnology ecosystem, and lead transactions from initial outreach through diligence, negotiation, execution, and post-deal transition. The position is best suited for a scientifically credible, commercially driven BD leader who combines a strong network with the ability to operate hands-on in a fast-moving biotechnology environment. Key Responsibilities Lead out-licensing and strategic partnering activities for preclinical and clinical-stage therapeutic assets. Originate new opportunities and proactively identify pharmaceutical and biotechnology partners aligned with individual assets and portfolio strategy. Own transactions throughout the deal lifecycle, including partner identification, outreach, evaluation, due diligence, valuation, negotiation, and execution . Develop compelling partnering strategies and positioning for individual therapeutic programs. Build and maintain senior-level relationships across biotechnology, pharmaceutical, investment, and broader life sciences organizations. Partner closely with scientific, clinical, finance, legal, and executive leadership throughout transaction processes. Evaluate market, competitive, scientific, and commercial intelligence to inform BD and portfolio strategy. Develop financial models and assess deal structures, economics, and strategic value. Support broader strategic transactions, collaborations, and potential M&A activities as needed. Provide mentorship and guidance to more junior members of the Business Development organization. Represent the organization at industry conferences and external partnering meetings. Operate effectively across a global and highly cross-functional organization. This individual will be at the center of deal execution while partnering closely with R&D, legal, finance, management, and external parties. Candidate Profile Advanced scientific degree strongly preferred, ideally a PhD in Biology, Medicinal Chemistry, Chemistry, or a related scientific discipline . Approximately 10+ years of biotechnology/pharmaceutical industry experience , with significant experience in Business Development, licensing, or strategic partnerships. Demonstrated track record of personally leading or materially contributing to large out-licensing transactions involving therapeutic assets . Proven ability to originate opportunities , rather than relying solely on inbound, inherited, or pre-existing transactions. Strong existing network of decision-makers and partnering contacts across biotechnology and pharmaceutical organizations. Deep understanding of the drug discovery and development lifecycle with the scientific fluency to assess assets and identify appropriate potential partners. Experience developing asset partnering strategies, financial models, valuations, and deal structures. Combination of large pharmaceutical and biotechnology experience strongly preferred. Commercially aggressive and entrepreneurial while remaining scientifically credible. Comfortable operating hands-on without extensive infrastructure or layers of support. Strong executive presence, negotiation skills, and ability to influence senior internal and external stakeholders. Experience mentoring or developing junior BD professionals. The position will involve periodic travel for conferences, partnering meetings, and client discussions. The formal specification identifies Boston as the location and emphasizes the ability to work independently while collaborating across a globally distributed organization.

Internal Sales, Marketing Specialist (Neuroscience) Position Overview A growing clinical research organization is seeking an Inside Sales and Marketing Specialist to build and lead its CRO relationship and marketing strategy. This remote role combines strategic relationship management, content development, conference planning, and commercial support within the neuroscience clinical research market. This position is well suited to a mid-career professional who wants to take long-term ownership of a function, build programs from the ground up, and become a trusted partner to CRO stakeholders. The role is more focused on relationship development and marketing than traditional quota-carrying sales. Key Responsibilities CRO Relationship Management Develop and maintain relationships with priority contract research organizations (CROs). Position the organization as a preferred clinical research site partner during feasibility assessments and bid-defense planning. Build and manage a target list of CRO accounts, stakeholders, and decision-makers. Establish recurring meetings with key CRO contacts. Coordinate the execution of master confidentiality disclosure agreements (CDAs). Track relationship activity, feasibility opportunities, site-selection outcomes, and related performance indicators in Salesforce. Partner with internal leadership on strategic CRO presentations and business development conversations. Increase awareness of the organization’s neuroscience capabilities among CRO clinical operations and feasibility teams. Marketing and Content Strategy Build the organization’s marketing infrastructure, processes, and calendar. Develop and manage a consistent LinkedIn posting schedule. Create a data-driven content strategy tailored to neuroscience sponsors and CRO audiences. Translate clinical research capabilities, performance data, and neuroscience expertise into compelling commercial content. Prepare presentations, marketing materials, and thought-leadership content. Use engagement and performance data to evaluate and improve marketing effectiveness. Conference Strategy Develop the annual strategy for approximately three to five industry conferences. Identify conferences with the strongest neuroscience, sponsor, and CRO audiences. Schedule meetings with priority contacts before each event. Coordinate messaging, outreach, presentations, and follow-up activities. Measure conference performance and recommend improvements to increase return on investment. Work with administrative support on travel and event logistics while retaining ownership of conference strategy. Qualifications Experience in clinical research, neuroscience, life sciences, contract research organizations, clinical trial site networks, biotechnology, pharmaceuticals, or a related field. Knowledge of neuroscience clinical development, ideally including Alzheimer’s disease, psychiatry, or other central nervous system indications. Understanding of sponsor priorities and CRO site-evaluation and selection processes. Experience developing CRO relationships or working directly within a CRO environment is strongly preferred. Ability to translate clinical research data and operational capabilities into effective marketing content. Strong presentation, relationship-building, and stakeholder-management skills. Experience creating professional presentations and leading external business conversations. Proficiency with Salesforce, Microsoft PowerPoint, and LinkedIn. Strong organizational skills and the ability to independently build new programs and processes. Willingness to travel to approximately three to five conferences annually. Preferred Background Previous experience working for a CRO, clinical trial site network, life sciences consultancy, biotechnology company, pharmaceutical company, or clinical research vendor. Experience spanning CRO operations, relationship management, consulting, marketing, or commercial strategy. Advanced scientific or clinical training in neuroscience or a related discipline is a plus. Demonstrated ability to communicate credibly with scientific, clinical, operational, and commercial audiences. Measures of Success Success will be evaluated through relationship and marketing milestones rather than a traditional sales quota. Initial objectives may include: Launching and maintaining a consistent LinkedIn content schedule. Establishing standing meetings with priority CRO partners. Securing five new master CDAs with target CROs. Increasing qualified feasibility opportunities. Improving selection rates for priority clinical research sites. Building a measurable and repeatable conference strategy. Strengthening awareness of the organization’s neuroscience research capabilities. Location and Travel Remote position with location flexibility. Travel to approximately 3 to 5 industry conferences per year. This is not a high-travel position.

Senior Manager, Clinical Operations Boston, Massachusetts – Onsite A growing clinical research organization is seeking a Senior Manager, Clinical Operations to lead site operations, staff development, compliance initiatives, and clinical trial execution within a fast-paced research environment. Responsibilities: Lead and develop Clinical Research Coordinators, Research Assistants, and other site personnel Oversee day-to-day clinical trial operations, enrollment activities, study conduct, and site performance Ensure compliance with GCP, FDA regulations, study protocols, and quality standards Drive operational excellence through process improvement, problem-solving, and risk mitigation Partner with internal stakeholders to support staffing, resource planning, budgets, and study execution Serve as a key point of contact for sponsors, monitors, and external partners Support audits, inspections, quality initiatives, and corrective action planning Qualifications: Bachelor's degree required 5+ years of clinical research experience 2+ years of people management experience Strong understanding of GCP, FDA regulations, and clinical trial operations Proven leadership, communication, and organizational skills Experience managing complex operational challenges in a clinical research environment Research site leadership experience strongly preferred

Nurse Practitioner or Physician Assistant Boston, Massachusetts | Onsite | Full Time Position Overview A growing clinical research organization is seeking a full-time, onsite Psychiatric Nurse Practitioner or Physician Assistant in Boston. The role combines Sub-Investigator medical support with clinical rating responsibilities, supporting physician investigators and conducting standardized psychiatric and neurologic assessments for sponsored clinical trials. Ideal for a licensed NP or PA with psychiatric or neurologic patient care experience who is interested in clinical research. Prior research experience is preferred but not required. Key Responsibilities Conduct protocol-required physical, neurological, and psychiatric assessments Review labs, ECGs, adverse events, and concomitant medications Perform standardized clinical interviews and rating scales Monitor participant safety, protocol compliance, and data quality Collaborate with investigators and the research team Follow GCP and regulatory requirements Qualifications Active NP or PA license in good standing Psychiatry, neurology, or behavioral health experience Experience with psychiatric and/or neurologic patients preferred Comfortable performing physical exams and reviewing labs/ECGs Clinical research or standardized psychiatric assessment experience is a plus

Director/Senior Director, Clinical Development Location: New Jersey Employment Type: Full-Time Function: Clinical Development Position Overview A clinical-stage biopharmaceutical company is seeking an experienced Director or Senior Director of Clinical Development to provide medical and scientific leadership across its oncology portfolio. This individual will lead the strategy, design, execution, and interpretation of clinical trials while collaborating with cross-functional teams to generate high-quality clinical data supporting product development, regulatory submissions, and broader business objectives. Key Responsibilities Lead the design and execution of clinical development programs based on medical, scientific, regulatory, and commercial objectives. Provide strategic medical input throughout the product lifecycle, from early clinical development through Phase 3. Oversee the medical integrity, quality, and execution of clinical trials. Partner with Clinical Operations to support patient enrollment, study timelines, and key development milestones. Monitor clinical safety in collaboration with Pharmacovigilance and Safety teams, including oversight of serious adverse event reporting. Lead or contribute to clinical documents, including protocols, Investigator’s Brochures, Clinical Study Reports, regulatory submissions, and health authority response packages. Serve as the medical lead for cross-functional clinical study teams. Represent Clinical Development during regulatory interactions and external scientific discussions. Ensure compliance with GCP, pharmacovigilance requirements, internal procedures, and applicable global regulations. Provide clinical expertise for assigned compounds and oncology indications. Build relationships with investigators, external experts, and key opinion leaders to inform clinical strategy and protocol development. Maintain current knowledge of oncology research, clinical practice, competitive developments, and evolving regulatory expectations. Qualifications M.D. or equivalent medical degree. International medical degrees will be considered. At least two years of medical monitoring experience supporting oncology clinical trials. Phase 1 and Phase 2 oncology experience required. Phase 3 experience preferred. Previous experience within a biotechnology or pharmaceutical clinical development organization. Demonstrated experience overseeing clinical trial safety and interpreting medical and safety data. Experience supporting the development of biologic oncology therapies, including antibody-based or immuno-oncology programs, strongly preferred.