Senior Director, Regulatory Affairs

Location

Massachusetts

Posted

16 days ago

Salary

0

Seniority

Mid Level

Bachelor Degree

Job Description

Senior Director, Regulatory Affairs

Bicara Therapeutics

Title: Senior Director, Regulatory Affairs Location: Boston Department: Development Job Description: Bicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory lead with a core focus on BLA strategy and execution—from IND through BLA submission and approval. You will manage a small team of Regulatory Affairs professionals, providing mentorship and oversight while working in close partnership with the VP to ensure alignment on regulatory direction, agency interactions, and submission timelines. This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week. Responsibilities - Develop and execute integrated global regulatory strategies to advance investigational oncology assets from early development through approval and lifecycle management, partnering closely with the VP, Regulatory Affairs. - Serve as the global regulatory lead on assigned programs, providing strategic guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, and Commercial). - Lead the planning, preparation, and submission of high-quality regulatory documents to FDA, including INDs, briefing documents, orphan/breakthrough designations, amendments, annual reports, and NDA/BLAs. Collaborate with external vendors for submissions in other regions. - Plan, prepare, and lead health authority interactions, including pre-IND, Type B/C, EOP, and pre-submission meetings; coach and prepare cross-functional teams for successful engagements. - Lead and manage a small US team of regulatory professionals; set priorities, allocate work, and cultivate a collaborative, accountable team culture. - Anticipate regulatory risks across regions and proactively design mitigation strategies; advise on regulatory implications of program decisions. - Monitor and interpret evolving global regulations, ICH guidelines, and oncology-specific policies (e.g., Project Optimus, accelerated approval reform), and translate them into actionable strategy. - Partner with external collaborators, CROs, regulatory consultants, and co-development partners to ensure aligned, efficient execution of global regulatory plans. - Ensure compliance with applicable global regulations and internal quality and SOP requirements; maintain audit-ready regulatory documentation and inspection readiness. Qualifications - Bachelor's degree in a life sciences discipline required; advanced degree (MS, PharmD, PhD, or MD) preferred. - 10-12 years of progressive regulatory affairs experience in the biotech or pharmaceutical industry. - Prior oncology/hematology regulatory experience required, with a track record of contributing to oncology development programs across multiple phases. - Demonstrated experience leading global regulatory strategy, including direct engagement with FDA and EMA; experience with additional ICH regions (e.g., PMDA, Health Canada) strongly preferred. - Proven success leading and preparing teams for health authority meetings and delivering major regulatory submissions (IND/CTA and, ideally, NDA/BLA/MAA). - Demonstrated ability to manage within a cross-functional matrix; prior people management experience highly preferred. - Deep working knowledge of global regulatory requirements, ICH guidelines, and oncology-specific frameworks and expedited pathways (e.g., Breakthrough Therapy, Fast Track, Accelerated Approval, PRIME, orphan drug). - Strong leadership, influencing, and project management skills; comfortable operating within a nimble and fast-paced environment typical of a small, clinical-stage biotech. - Exceptional written and verbal communication skills, including experience presenting to and negotiating with health authorities and senior internal stakeholders. - Detail-oriented, highly organized, and able to manage multiple priorities and competing deadlines. Company Overview Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply. Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Related Categories

Related Job Pages

More Medical Director Jobs

OtherRemoteTeam 10,001+Since 1982H1B No Sponsor

Role Description Do you crave an intellectually stimulating role that lets you apply your clinical expertise while continuing to grow and make an impact? As a Medical Director at EviCore, part of Evernorth Health Services, a division of The Cigna Group, you’ll leverage your background in Pain Medicine disciplines to deliver evidence-based medical reviews that support high-quality patient care. Collaborate with healthcare providers and stay current on healthcare regulations and industry developments as you review a wide range of cases. This role offers you the opportunity to build new skills while enhancing the health and vitality of others. We're seeking a detail-oriented individual with good communication, technology, and typing skills, as well as strong clinical judgment. Drive growth in your career with our innovative team. - You’ll start training remotely in a structured environment with support from trainers, mentors, and leadership to set you up for success. - Complete time-sensitive, specialized evidence-based medical case reviews for medical necessity on EviCore’s case management software. - Conduct physician consultation (peer-to-peer) calls with referring providers to discuss evidence–based medical necessity and appropriateness of the requested service or treatment. - Leverage your clinical expertise to recommend alternative services or treatments as necessary. - Work collaboratively with over 500 EviCore physician colleagues to help ensure patients receive proper care via evidence-based decision making. Qualifications - M.D. or D.O. with a current, active U.S. medical license and board certification (ABMS or AOA) in Physical Medicine and Rehabilitation. - Clinical interventional pain experience required. - Eligible to acquire additional state licensure as required. - 3 or more years of relevant clinical experience post residency/fellowship. - Knowledge of applicable state and federal laws, Utilization Review Accreditation Commission and National Committee for Quality Assurance standards is a plus. Requirements - Ability to commit to a set, weekly work schedule (Monday through Friday). - Strong computer skills: ability to work autonomously with automated processes, computer applications, and systems. - Meet physical demands of the role including, but not limited to, typing, speaking, and listening 100% of the time. - In accordance with our HITECH Security Accreditation, company provided encrypted-workstation is required to be hard-wire connected to a modem or router. Wireless connection is not permitted. - If you will be working at home occasionally or permanently, the internet connection must be obtained through a cable broadband or fiber optic internet service provider with speeds of at least 10Mbps download/5Mbps upload. Benefits - Benefits start on day one. - Predictable work schedules. - 100% work from home. - 8 Paid Holidays + 23 PTO Days. - 401(K) with company match. - Reimbursement for continuing medical education. - Career growth opportunities across the enterprise. - Networking with peers across multiple medical specialties. Company Description Evernorth Health Services, a division of The Cigna Group, creates pharmacy, care and benefit solutions to improve health and increase vitality. We relentlessly innovate to make the prediction, prevention and treatment of illness and disease more accessible to millions of people. Join us in driving growth and improving lives.

United States
$207.8K - $346.3K / year
Bristol Myers Squibb logo

National Director, US Field Medical Immunology - Admilparant

Bristol Myers Squibb

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. With a single vision as inspiring as “Transforming patients’ lives through science™”, every BMS employee plays an integral role in work that goes far beyond ordinary.

Medical Director16 days ago
Full TimeRemoteTeam 10,001

Role Description The Field Medical organization embodies our medical mission to be recognized as the trusted partner for internal stakeholders and the healthcare community, driving scientific exchange to enhance medical education, data generation, insight generation, and patients’ access to medicine. The Director, Field Medical (FM) Immunology (IMM) - Admilparant role is field-based and focused on leading a team of Field Medical professionals. Direct reports will include field-based Regional Associate Directors (RADs) and Region Directors (RDs) who manage a team of field-based Immunology Medical Science Liaisons (MSLs) focused on Admilparant. The FM Director will be responsible for oversight of RADs/RDs and MSLs in support of BMS Immunology medicines, specifically Admilparant, and all phases of associated clinical trials and launch. Key Responsibilities - Ensure team’s ability to drive scientific exchange with Thought Leaders, appropriate HCPs, and access stakeholders. - Support and evaluate MSLs ability to effectively present information to HCPs and respond to questions. - Actively assess the medical landscape by meeting with Thought Leaders. - Understand the competitive landscape and prepare to address informational needs of customers. - Ensure MSLs capability to collect and provide meaningful medical insights. - Provide direction to overall execution of the Field Medical plan. - Ensure active support for CRO sponsored studies. - Oversee appropriate support of BMS sponsored and Interventional and Non-Interventional Research studies. - Enhance patient enrolment in BMS-sponsored clinical trials. - Oversee recommendations and insights to clinical development team on study and site feasibilities. - Ensure BMS Pharmacovigilance procedural documents are understood and applied. - Support MSL as a primary liaison to investigators interested in developing investigator-sponsored research. - Develop and oversee national Field Medical plan. - Actively participate in the cross-functional Medical Matrix Teams. - Provide Medical Support as necessary and appropriate. - Actively manage Regional Associate Directors and Region Directors. - Ensure compliance with all local laws and regulations as well as BMS policies and procedures. - Support employee development through coaching and direction. Qualifications - MD, PharmD, or PhD, with experience in Pulmonary Fibrosis or Science Graduate with relevant pharmaceutical experience. MBA a plus. - A minimum of 8+ years of clinical and/or pharmaceutical experience including a minimum of 6 years of FM experience. - Demonstrated ability to lead national field medical projects or initiatives. - Demonstrated ability in account management. - Experience working in cross-functional teams. - Experience coaching and mentoring within a FM organization. - In-depth knowledge of disease area, including key scientific publications. - Strong communication and presentation skills. Requirements - Clear understanding of customer (HCP and payer) and patient needs. - Knowledge of principles and implications of pharmacoeconomic data. - Knowledge of the US Healthcare System and the Pharmaceutical Industry. - Understanding of environmental and industry trends. - Knowledge of clinical trial design and relevant compliance standards. - Strong strategic thinking skills. Benefits - Health Coverage: Medical, pharmacy, dental, and vision care. - Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). - Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, and more. - Work-life benefits: Flexible time off, paid national holidays, and additional time off for various needs.

United States
$234.6K - $284.3K / year
Pfizer logo

Director, Medical Insights

Pfizer

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical Director16 days ago
Full TimeRemoteTeam 10,001+Since 1849H1B Sponsor

Role Description Across Medical Affairs, Pfizer Medical colleagues engage with healthcare professionals and other stakeholders to generate insights that inform medical strategy, evidence generation, and execution. The Director, Medical Insights plays a key role in advancing Pfizer’s Medical Insights capabilities by helping shape, implement, and continuously improve Medical Insights processes across Medical Affairs and the broader enterprise. The role serves as a subject matter expert for Medical Insights, partnering closely with: - Medical Engagement & Impact (MEI) - US Medical Affairs - Digital & Technology - Medical Systems - Other stakeholders A core focus of the role is to maximize the value and impact of Medical Insights by embedding them effectively into medical processes, strategic discussions, and decision-making, leveraging advanced analytics, artificial intelligence, and emerging technologies to translate complex medical data into actionable insights that support scalable, value-driven, and data-informed decisions across Pfizer’s portfolio of medicines. Qualifications - Bachelor’s degree or higher in Life Sciences, Biomedical Sciences, Pharmaceutical Sciences, Data Sciences, Data Analytics, or a related field. - 8+ years of relevant experience in the pharmaceutical or life sciences industry; 7+ with Masters; 5+ with PharmD/PhD. - Demonstrated experience in Medical Affairs, Medical Analytics, Medical Strategy, Medical Communications, Research & Development, or a related function. - Experience (3+ years) in analyzing, interpreting, and synthesizing data and insights. - Proven effectiveness operating in complex, cross-functional, matrixed, and global environments. - Strong interpersonal and communication skills. - Ability to partner effectively across cultures, regions, and organizational boundaries. - Solid understanding of the pharmaceutical and Medical Affairs operating environment. Requirements - Contribute to the development and evolution of Medical Insights strategies, frameworks, standards, and ways of working. - Drive alignment of Medical Insights approaches across Medical Affairs. - Participate in Medical Insights governance and planning forums. - Identify and help prioritize opportunities across the end-to-end Medical Insights lifecycle. - Define and refine Insights use cases and business questions. - Translate business needs into clear functional and data requirements. - Evaluate analytics and AI-enabled capabilities from a Medical perspective. - Guide the application of advanced analytics and AI-enabled approaches. - Embed Medical Insights into core Medical processes. - Define and monitor indicators of value and impact. - Enable effective use of Medical Insights platforms and tools. - Build strong, collaborative relationships across Medical Affairs and partners. Benefits - 401(k) plan with Pfizer Matching Contributions. - Paid vacation, holiday, and personal days. - Paid caregiver/parental and medical leave. - Health benefits including medical, prescription drug, dental, and vision coverage.

United States
$176.6K - $294.3K / year
Job Closed
Personify Health logo

Medical Director

Personify Health

Because health is personal

Medical Director16 days ago
Part TimeRemoteTeam 1,001-5,000Since 2023H1B No Sponsor

Role Description The Medical Director relies on their medical background to review claims for medical necessity for prior authorization, continued stay review, and post service. The Medical Director can read, interpret, and apply medical policy, guidelines, and research to utilization review. The Medical Director has authority for issuing adverse determinations while performing medical necessity evaluation. - Has discussions with external physicians by phone to gather additional clinical information or discuss determinations regularly, requiring conflict resolution skills. - Includes an overview of coding practices and clinical documentation, grievance and appeals processes, and outpatient services and equipment. - Keep the team informed of clinical updates through educational opportunities by developing educational materials for staff. - Work with the VP of Care management to establish work procedures and processes that support company and departmental standards, procedures, and strategic directives. - Excellent verbal and written communication skills. - Evidence of analytic and interpretation skills, with prior experience in quality management, utilization management, case management, discharge planning, and/or home health or post-acute services. - Knowledge of the managed care industry as it relates to commercial business. - Oversee negotiation and implementation of cost management strategies to affect quality outcomes. - Exercises independence in meeting departmental expectations and compliance timelines. - Ability to meet productivity, quality, and turnaround times daily. - Ability to pass external audits to include URAC and NCQA. - Maintain HIPAA compliance per company’s policy and procedures. - Maintain confidentiality and minimum requirement rules. - Complete all required yearly training per company’s expected period. Qualifications - MD or DO degree and 5+ years of direct clinical patient care experience post residency or fellowship, preferably including some experience in an inpatient environment. - Current and ongoing Board Certification in an approved ABMS Medical Specialty. - A current and unrestricted license in the state of California and willing to obtain additional license(s), if needed. (Optional) - No current sanction from Federal or State Governmental organizations, and able to pass credentialing requirements. - Minimum 5 years of Utilization Review or Hospital experience required. - Minimum 3 years of compliance-related experience preferred. - Managed Care experience preferred in utilization review and case management. Requirements - Ability to perform essential job functions safely and successfully with or without reasonable accommodation. - Ability to maintain regular, punctual attendance. - Ability to sit for 6-8 hours. - Constant use of computer keyboard and mouse; repetitive use of both hands. - Occasional to frequent twisting of neck; occasional bending of neck and at waist. Benefits - Part-time schedule designed around your availability and life priorities. - Access to learning and development opportunities alongside full-time colleagues. - Mentorship and skill-building that translates to career advancement. - Competitive hourly compensation that values your expertise. - Technology and equipment support to set you up for success.

California
$91 - $114 / hour
Job Closed