Director, Medical Information Job at Alfasigma (San Diego)

Director, Medical Information

Beam is seeking a driven and scientifically rigorous Director of Medical Informa...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced scientific degree required: PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field
Minimum 7 years of experience in Medical Information, Medical Affairs, or Medical Communications within the pharmaceutical or biotechnology industry
Experience contributing to or building Medical Information capabilities, including SOP development and content library management
Solid working knowledge of medical review processes (MRC/PRC) and promotional/non-promotional content review, with familiarity with applicable FDA and EMA regulations
Strong scientific writing skills with experience developing SRDs, medical information responses, and clinical content for internal and external audiences
Ability to work effectively cross-functionally in a fast-paced, pre-commercial biotech environment with lean teams and evolving priorities
Interest in or exposure to rare disease therapeutic areas, including the scientific and operational challenges of small patient populations
Experience in cell and gene therapy, gene editing, or other advanced therapy medicinal products, preferred
Exposure to AI/ML applications in Medical Affairs or Medical Information, including prompt engineering, LLM evaluation, or AI governance, preferred
Familiarity with medical information platforms (e.g., Veeva Vault, Salesforce Health Cloud, MedAnswers) or emerging AI-powered MI solutions, preferred

Job Responsibility

Establish the Medical Information department from the ground up, including defining the operating model, staffing plan, technology infrastructure, and standard operating procedures (SOPs)
Develop and maintain the MI quality framework to ensure all scientific content meets regulatory, compliance, and scientific integrity standards
Serve as the internal subject matter expert on medical information best practices, regulatory expectations (FDA, EMA), and industry benchmarks for rare disease and advanced therapies
Build and oversee the medical review process for promotional and non-promotional materials, ensuring scientific accuracy and alignment with label and clinical data
Partner in the establishment of a Medical Review Committee (MRC) / Promotional Review Committee (PRC), collaborating closely with Regulatory Affairs, Legal, and Commercial teams
Create and maintain a comprehensive library of standard response documents (SRDs), custom responses, and medical FAQs covering the company's cell and gene therapy pipeline across rare disease indications
Author and review medical information letters, disease education materials, clinical summaries, and scientific dossiers for internal and external use
Ensure all MI content reflects the most current evidence base, including clinical trial data, real-world evidence, and peer-reviewed literature
Partner with Medical Science Liaisons (MSLs), Clinical Development, and Commercial teams to develop scientifically rigorous training materials, slide decks, and internal reference tools
Lead the development of pipeline and disease area resources that enable cross-functional teams to communicate accurately about the science of cell and gene therapies

Fulltime

Associate Medical Director, US Medical Affairs

The Associate Medical Director will be responsible for contributing to and parti...

Location

United States , Morristown

Salary:

180000.00 - 210000.00 USD / Year

Alfasigma

Expiration Date

Until further notice

Requirements

MD/PhD/PharmD (or equivalent) with a minimum of 5 years of professional/clinical experience
At least 3 years of biopharmaceutical industry experience in Medical Affairs and/or Clinical Research is required
Experience working with professional societies and quality organizations preferred
Prior experience in Hepatology, Gastroenterology, or Immunology preferred
Ability to travel up to 20% required (mostly to congresses/ad boards), which may include overnight and/or weekend travel
Strong understanding of Medical Affairs functions, processes, and strategic execution
Track record of being held accountable for key individual deliverables with successful results required
Strong verbal and written communication skills are essential, including strong presentation skills
Excellent organization and multi-tasking skills
Strong interpersonal skills and problem-solving capabilities

Job Responsibility

Participate in the development of a cross-functionally aligned set of medical strategies for the US market needs, focused on commercialized as well as late-stage development indications/assets
Develop the strategy for professional medical association engagement in the US in conjunction with other US stakeholders as part of the broader professional society strategy
Support medical affairs data generation and dissemination working group(s) and collaborate with the Scientific Communications team to develop and execute aligned strategies/tactics for maximizing our scientific communication efforts
Support field medical activities and help to assess and address internal/external medical education needs in collaboration with the Field Medical and Scientific Communications teams
Perform scientific and clinical training for internal staff, including Commercial/Sales, on Alfasigma products and respective disease-related aspects
Lead and execute scientific advisory boards to generate strategic insights that inform medical affairs plans
Participate in or perform review of promotional and medical/scientific materials as the Medical Reviewer, following standard operating practices (SOPs) and in collaboration with Regulatory, Legal, and Commercial counterparts
Maintain strong relationships with the external thought leader and influencer communities
Contribute to, and support execution of the lifecycle management activities for Alfasigma’s commercialized indications/assets
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team

What we offer

401(k) plan with company match
Rewards and recognition program
Health care benefits (medical, prescription drugs, dental, and vision insurance)
Short and long-term disability coverage provided
Plan coverage for domestic partners
Paid parental leave benefits and adoption assistance
Tuition reimbursement assistance
A generous Paid Time Off program that includes 20 vacation days, 11 holidays, 4 personal days, and 2 volunteer days per calendar year
Numerous well-being and work/life programs

Fulltime

Medical Director/Sr Medical Director - Neurology

Join Us as a Medical Director – Make an Impact at the Forefront of Innovation. A...

Location

United States

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

MD or equivalent required
Active medical licensure preferred
Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years), i.e. Neurology Residency/Fellowship
Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry
Direct experience in safety/Pharmacovigilance (comparable to 2 years)
Therapeutic expertise across one or more medical specialty or sub-specialties
Strong decision-making, problem solving, organizational skills and analytical skills
Excellent oral and written communication skills
Working knowledge of relevant safety databases (e.g. Medra)
Flexibility to travel domestically and internationally

Job Responsibility

Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle
Ensure tasks delegated to PV are properly executed
Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues
Follow client SOPs/directives and project-specific WPDs for assigned projects
Comply with CRG’s corporate policies and SOPs/WPDs
Provide medical consultation to team members and answer all study-related medical questions
Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately
Provide therapeutic training and protocol training on assigned studies, as requested
Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete
Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies

Fulltime

Medical Director/Senior Medical Director, Clinical Development, Genetic Diseases

The Medical Director in Clinical Development will serve as the Medical Lead for ...

Location

United States , Cambridge

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD, DO or equivalent ex-US medical degree with 15+ years experience
Minimum of 4 years of Pharmaceutical/Biotech industry experience in clinical development and medical monitoring
Board certification/eligibility in endocrinology or metabolic disorders, or another relevant specialty highly desired
Strong oral and written communication skills to influence others
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Clinical development and/or clinical experience in rare disease, cell & gene therapy is a plus
Ability to work independently to resolve challenges

Job Responsibility

Serves as the Clinical Development lead on the cross-functional Program Team and co-lead the Clinical Development Sub-team for assigned programs
Support development of Target Product Profile (TPP) and Clinical Development Plan (CDP)
Serves as the medical monitor for assigned studies including design, execution and interpretation study data
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology and biomarker analysis plans
Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP)
Contribute to the development of regulatory documents in support of regulatory submissions, including clinical section of IND's and CTA's, safety reports, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
Acts as liaison between Clinical Development and other internal groups at BEAM for assigned studies
Establishes strong collaborations with study investigators, outside medical experts and represents BEAM during investigator meetings and advisory boards
Contribute to the development and planning of Advisory Board meetings in the relevant therapeutic areas

Fulltime

Medical Director, Health & Counseling Center

The University of Denver seeks a student-centered physician leader to serve as t...

Location

United States , Denver

Salary:

225000.00 - 250000.00 USD / Year

The University Of Denver

Expiration Date

Until further notice

Requirements

MD or DO degree from an accredited institution
Current unrestricted license to practice medicine in Colorado, or eligibility for Colorado licensure by the start of employment, full prescriptive authority, NPI number
Board certification in family medicine, internal medicine, or another specialty relevant to college health
DEA registration and other credentials required for clinical practice and prescribing, as applicable
Required 7 years’ experience in a primary care setting after residency with at least 3 years leading clinical and/or administrative operations such as quality improvement, patient safety initiatives, and supervising staff
Current BLS/ACLS
Eligible to obtain adequate professional liability insurance coverage

Job Responsibility

Provides direct outpatient medical care to University of Denver students through scheduled visits, same-day access, follow-up appointments, and other clinical services consistent with the scope of HCC medical practice
Delivers student-centered, evidence-based, developmentally and trauma-informed care to a diverse student population, with attention to access, continuity, prevention, and health education
Participates in clinical coverage, consultation, documentation, care coordination, and referral management to support safe, timely, and effective student care
Collaborates closely with counseling, psychiatry, health promotion, and Student Affairs partners to support students whose needs intersect across physical health, mental health, and campus functioning
Models clinical excellence, professionalism, and a strong commitment to equity, confidentiality, and service in the delivery of care
Serves as the supervising/collaborating physician of record for advanced practice providers within the HCC
Provides strategic and clinical leadership for medical services within the Health & Counseling Center, including primary care and related outpatient services
Ensures high-quality, student-centered, accessible, and clinically appropriate medical care for DU students
Oversees clinical standards, scope of practice, documentation expectations, protocols, and quality improvement processes for medical services in service of ongoing AAAHC certification
Partners with clinical and administrative leaders to optimize access, continuity, scheduling, triage, patient flow, and the overall student experience of care

What we offer

Fringe benefits (including malpractice insurance, license fees, workers' compensation, and DEA renewal)

Fulltime

Medical Director

Medical Director (Part-Time) Care Management California, United States Because...

Location

United States , California

Salary:

91.00 - 114.00 USD / Hour

Personify Health

Expiration Date

Until further notice

Requirements

MD or DO degree and 5+ years of direct clinical patient care experience post residency or fellowship, which preferably includes 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
Basic computer literacy
The ability to work on multiple screens, and proficient typing skills
Proficiency in software applications including, but not limited to, Microsoft Word, Microsoft Excel, and Outlook

Job Responsibility

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, and in some instances, these may require conflict resolution skills
Some roles include an overview of coding practices and clinical documentation, grievance and appeals processes, and outpatient services and equipment, within their scope
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 participating in teams focusing on quality management, utilization management, case management, discharge planning and/or home health or post-acute services (such as inpatient rehabilitation)
Knowledge of the managed care industry as it relates to commercial business

What we offer

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

Parttime

Center Medical Director

We're building a world of health around every individual — shaping a more connec...

Location

United States , Allentown

Salary:

174070.00 - 374920.00 USD / Year

CVS Health

Expiration Date

March 03, 2027

Requirements

M.D., D.O., or A.P.N or P.A. graduates
Board certification in Internal Medicine or Family Medicine required for M.D. or D.O., Board certification in Family, Adult, or Gerontology for A.P.N
Experience in clinical leadership roles, leading and coaching providers to be the best they can be for their patients and their colleagues
Experience using a metrics-driven approach to the provision of medical care and/or quality projects
Passionate about their work and motivated to be a part of a fast growing organization
Aware of their leadership skills and potential for impact and eager to share those with a fast-growing, energetic team on the leading edge of healthcare innovation
Commitment to older adults and to low-income patients
Comfort with ambiguity and a love for problem solving
Ability to remain calm in the midst of the storm, guiding others to smart, effective solutions
5+ years of experience in outpatient practice preferred

Job Responsibility

Lead the clinical team at their center in providing the best patient care and a great place to work in order to keep patients happy, healthy and out of the hospital
Practice primary care in our clinics alongside their provider colleagues at 80% clinical time and 20% administrative time
Setting an example for how thoughtful primary care is practiced
Serving as a formal mentor, coach, and advisor to providers in Oak Street clinics
Participating in critical organizational-wide strategic initiatives
Work in tight collaboration with the Practice Manager and Outreach Manager/Director to achieve organizational objectives
Drive implementation of OSH strategic initiatives
Follow direction from regional leadership
Cascade both organizational information to care team members as well as escalate care team concerns and ideas to the rest of the organization
Help coordinate and lead the onboarding of new providers at the center

What we offer

Affordable medical plan options
401(k) plan (including matching company contributions)
Employee stock purchase plan
No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching
Benefit solutions that address the different needs and preferences of our colleagues including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility

Fulltime

Sr Director, Medical Affairs

The Senior Director, UCAN Medical Affairs guides strategic and operational initi...

Location

United States , Deerfield

Salary:

224000.00 - 308000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD, or equivalent scientific/clinical doctorate)
10+ years of experience in Medical Affairs, Clinical, or Scientific roles within medical devices, pharmaceuticals, or combination products
Proven leadership of downstream and field-based medical organizations across complex portfolios
Deep understanding of medical governance, compliance, and scientific engagement in regulated environments
Applicants must be authorized to work for any employer in the U.S.
We are unable to sponsor or take over sponsorship of an employment visa at this time

Job Responsibility

Own and complete the downstream Medical Affairs strategy across Infusion Systems, IV Solutions, Clinical Nutrition, and Pharmacy products, aligned to regional and global medical objectives
Convert upstream medical strategy, clinical data, and evidence generation plans into tactical downstream medical plans that support launches, line extensions, lifecycle management, and in-market optimization
Ensure scientific and medical differentiation is clearly articulated and appropriately embedded across customer-facing medical activities
Lead and develop Field Medical teams (e.g., MSLs, clinical specialists) supporting downstream portfolios, ensuring consistent implementation, scientific rigor, and compliant HCP engagement
Coordinate Key Opinion Leader (KOL) strategy, including identification, engagement planning, and insight generation across therapy areas
Guide planning and execution of advisory boards, investigator meetings, educational forums, and non-promotional scientific exchanges
Responsible for scientific communication strategies supporting downstream portfolios, including data dissemination, congress strategy, and educational initiatives
Ensure accurate, balanced, and compliant communication of clinical evidence to internal and external collaborators
Collaborate with Medical Information, Clinical Development, and Global Medical teams to maintain uniformity in scientific narratives
Serve as the senior downstream medical partner to Commercial, Downstream Marketing, Sales, Training, Market Access, and Commercial Operations

What we offer

Medical and dental coverage starting on day one
Basic life insurance
Accident insurance
Short-term disability insurance
Long-term disability insurance
Business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs

Fulltime

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