Alfasigma

Role Description The SVP Therapeutic Area Head, Gastroenterology will serve as a senior scientific and strategic leader responsible for defining and executing the global strategy for the Gastrointestinal (GI) and hepatology therapeutic area. This individual will oversee the development and lifecycle management of the GI portfolio, ensuring alignment with corporate objectives, innovation priorities, and patient needs. The role will drive the advancement of the GI clinical pipeline, oversee portfolio investments, and collaborate closely with stakeholders across R&D, Regulatory, Medical Affairs, Commercial, and Business Development functions. As a recognized expert in gastroenterology and hepatology, this leader will also represent Alfasigma externally and build strong relationships with key opinion leaders, academic institutions, and scientific networks. - Lead the development and execution of the global Gastroenterology therapeutic area strategy aligned with corporate R&D and portfolio priorities. - Define long-term scientific, clinical, and portfolio strategies to strengthen Alfasigma’s leadership in GI and hepatology. - Monitor scientific, clinical, and competitive developments to identify emerging opportunities, unmet needs, and potential risks. - Lead the GI therapeutic area portfolio, including clinical pipeline programs and lifecycle management initiatives. - Oversee the successful execution of clinical development programs from early clinical development through late-stage development, registration, and post-approval lifecycle management. - Ensure alignment between scientific strategy, regulatory pathways, and commercial objectives. - Design development strategies and clinical programs for GI and hepatology assets. - Partner with Regulatory leadership to develop global regulatory strategies and submission plans. - Collaborate closely with Clinical Operations, Biometrics, Translational Science, CMC, and Regulatory teams to ensure efficient advancement of programs. - Serve as the GI therapeutic area lead for Business Development activities, including licensing, partnership, and acquisition opportunities. - Provide scientific and strategic leadership for due diligence evaluations and external innovation initiatives. - Own and manage the budget for the GI therapeutic area portfolio and allocate resources to maximize portfolio value and patient impact. - Ensure programs progress according to timelines, milestones, and financial objectives. - Establish and maintain strong relationships with key opinion leaders, academic institutions, and research networks in gastroenterology and hepatology. - Represent Alfasigma within the global scientific and medical community. - Collaborate with Global Medical Affairs, Strategic Marketing, Corporate Strategy, and Commercial teams to align development priorities with broader organizational goals. Qualifications - Minimum of 10 years of clinical development experience within the pharmaceutical or biotechnology industry. - Extensive experience across early and late-stage drug development (Phase I–III). - Medical degree (MD) required; advanced scientific training in biological sciences or related disciplines preferred. - Deep expertise in gastroenterology, hepatology, or related therapeutic areas. - Demonstrated success leading complex global clinical development programs. - Experience contributing to therapeutic area strategy, portfolio management, lifecycle planning, and business development activities. - Rare disease experience within GI and/or hepatology is highly desirable. - Strong understanding of gastrointestinal disease biology, treatment paradigms, and emerging therapeutic modalities. - Knowledge of the competitive landscape, clinical innovation, and evolving scientific trends within GI and hepatology. - Experience with innovative clinical trial design and development of novel therapeutic approaches. - Ability to develop and execute long-term therapeutic area strategies aligned with enterprise objectives. - Strong business acumen, portfolio management capabilities, and strategic decision-making skills. - Proven ability to influence and engage cross-functional stakeholders within a matrix organization. - Strong relationship-building skills with internal teams, external experts, and scientific leaders. - Demonstrated success building and leading high-performing scientific and clinical teams. - Ability to balance scientific rigor, operational execution, financial stewardship, and strategic priorities. - Strong track record of delivering complex development programs and achieving key milestones. Benefits - Foster a culture where scientific excellence, innovation, and patient impact are at the core of everything we do. - Highly visible leadership opportunity to shape the future of one of the company’s most strategic therapeutic areas. - Work alongside talented colleagues across a global organization. - Commitment to patients, science, and innovation drives pursuit of transformative therapies. - Value diverse perspectives, collaboration, and entrepreneurial thinking.

Role Description This position represents one or more Regions / Countries on the Regulatory Sub team and supports the creation / maintenance of the Regional Regulatory Strategy, as part of the Global Regulatory Strategy, for one or more assigned medium-complexity programs / single approved asset and leads its locoregional implementation. The position liaises between Country Regulatory and the asset Global Regulatory Sub team. The Senior Manager operates with limited guidance and oversight and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to NDA/MAA submissions and clinical study start-up and execution, including document review, CTA approval, etc. - Support development and locoregional implementation of regulatory strategies for at least one medium-complexity program (single asset) - Identify and communicate potential regulatory risks and mitigations to the Regulatory Subteam - Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies - Regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, pediatric plans, briefing books, DSURs, annual reports, etc., to ensure content and format meet all regulatory requirements - Lead coordination of locoregional IND/CTA and/or NDA/MAA submissions and supplements, while managing and partnering with CRO - Lead development regional regulatory submission plans - Support product development and lifecycle management activities - Represent Regulatory Sciences on the Study teams, and assess regulatory pathways for submissions to the FDA and other regulatory agencies - Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards - Assume other relevant assignments as assigned - Provide mentorship and support to colleagues to support their activities and help with the production of appropriate reports and documents - Assist Regulatory department in the update and creation of internal policies and procedures - Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team - Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities Qualifications - Bachelor’s degree (minimum 8 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D; minimum 5 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research - Understanding of/experience supporting and/or leading IND/CTA and NDA/MAA (and supplement) submissions - Experience overseeing regulatory collaboration with CROs or other partnering organizations and coordinating US and/or international submissions to meet regulatory requirements is desired - Strong verbal and written communications skills - Exceptional interpersonal and problem-solving skills - Excellent project and/or program management skills - Learning agility and ‘scalability’ to take on increasing responsibility as Company X grows - Ability to work effectively across a highly complex, fast paced, matrix organization - Understanding of the legal and compliance environment - Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity - Advanced functional experience with MS Office Suite Benefits - Competitive salary - Comprehensive benefits - Extensive opportunities for professional growth and development

Role Description As we continue to grow, we are seeking a Manager, Regulatory Lead. This position will be located remotely on the east coast (EST) of the United States. Scope of the role: - This position represents one or more Regions / Countries on the Regulatory Sub team and supports the creation/maintenance of Regional Regulatory Strategy as part of the Global Regulatory Strategy for no more than one low complexity program/single asset. - The manager works under supervision and provides regulatory support to Clinical Operations and Clinical Development for various activities relating to clinical study start-up and execution, including document review, IND/CTA approval, etc. Your key responsibilities: - Contribute to development and local/regional implementation of regulatory strategies for a low complexity program/single asset. - Support planning, coordination, and preparation for meetings, including teleconferences with locoregional regulatory agencies. - Contribute to regulatory review of study documents such as protocols, protocol amendments, ICFs, CSRs, IMPDs, IBs, and annual reports to ensure content and format meet all regulatory requirements. - Contribute to development of regulatory submission plans. - Assist with coordination and submission of locoregional IND/CTA submissions and maintenance activities. - Support product development and lifecycle management activities. - Support assessment of regulatory pathways for submissions to the FDA and other regulatory agencies. - Manage multiple tasks in a fast-paced environment while keeping on task and to the company's quality standards. - Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities. Qualifications - Bachelor’s degree (minimum 5 years relevant experience) or advanced scientific degree (MS, PhD, Pharm D; minimum 3 years relevant experience) in regulatory affairs or pharmaceutical industry and/or clinical research. - Experience supporting and/or leading IND/CTA submissions. - Understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory). - Strong verbal and written communications skills. - Excellent project and/or program management skills. - Detail-oriented and ability to achieve results across functions and levels. - Ability to work effectively across a highly complex, fast paced, matrix organization. - Proficiency in MS Office Suite. - Learning agility and 'scalability' to take on increasing responsibility as Intercept grows. - Consistent demonstration and embodiment of company core values: Collaboration, Excellence, Innovation, Integrity, Passion, Patient/Stakeholder Centricity. Benefits - Competitive salary range. - Comprehensive benefits. - Extensive opportunities for professional growth and development.

Role Description As we continue to grow, we are seeking a Sr. Manager, Medical Writing. This is a remote based position and can be in Europe or on the East Coast of the US. The Senior Manager, Medical Writing, leads authoring of complex documents for one or more clinical development programs. - Leadership: - Train junior medical writers on best practices in medical writing and regulatory submission processes. - Help oversee vendor partnerships. - Writing: - Lead author (including content planning, writing, and review) for clinical study protocols, clinical study reports (CSRs), investigator brochures, and other study-level documentation required for clinical trials. - Author individual modules of IND/CTA, NDA, MAA requests for information and briefing documents for regulatory agencies. - Review Summary of Clinical Efficacy (SCE) and Summary of Clinical Safety (SCS) statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. - Quality Control: - Coordinate for the quality and compliance of written components to company standards as well as regulatory requirements. - Project Management: - Create document timelines and coordinate reviews with cross-functional teams and contract research organizations (CROs). - Manage vendor/contract medical writers. - Collaboration: - Collaborate with cross-functional teams to analyze complex scientific data for the above-mentioned document types. - Lead the document review process for study-level, submission, and regulatory interaction documents, through management of timelines, scheduling of meetings, and incorporation of feedback from cross-functional teams. - Represent Medical Writing on Clinical Study Team(s) (CST[s]). - Literature Reviews: - Conduct thorough literature reviews and synthesize complex scientific data into clear and concise documentation. - Department Administration: - Oversee quality and adherence to document templates and standard operating procedures (SOPs). - Regulatory Standards: - Ensure all documents adhere to regulatory guidelines, formatting standards, and internal quality standards. - Maintain up-to-date knowledge of industry trends and regulatory changes and provide oversight to ensure that standards are being applied through review of documents produced by other team members. Qualifications - Bachelor's degree in life sciences with minimum 8 years’ relevant experience in medical writing or pharmaceutical industry and/or clinical research OR - Advanced scientific degree (MS, PhD, Pharm D) with a strong background in relevant scientific discipline with minimum 5 years of relevant experience in medical writing or pharmaceutical industry and/or clinical research. - Experience supporting and/or leading individual components of INDs, NDAs, and MAAs, as well as briefing books. Requirements - Strong verbal and written communications skills coupled with general knowledge of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies and regulatory documents. - Detail-oriented, with good organizational, prioritization, and time management proficiencies; proactive approach. - Ability to work cross-functionally. - Advanced computer software experience (including but not limited to MS Word, Excel, PowerPoint). - Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans. - Proven ability to facilitate issue/comment resolution as it relates to finalization of medical writing deliverables. - Ability to thrive and adapt in times of uncertainty. Benefits - Competitive salary. - Comprehensive benefits. - Extensive opportunities for professional growth and development.