Medical Director, Clinical Development Job at Kailera Therapeutics (Waltham)

Senior Medical Director / Medical Director, Pharmacovigilance

The Medical Director of Pharmacovigilance (PV) will provide clinical/scientific/...

Location

United States , Cambridge, MA

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD required, Board certification preferred with 15+ years of experience
5+ years of pharmacovigilance experience
Experience in cell or gene therapy preferred
Experience as safety lead for asset/approved drug product e.g. Global Safety Lead
Oversight experience of global medical safety activities
Demonstrated knowledge of global PV regulatory environment
Working knowledge of industry standard safety databases (ARGUS and ARISg)
Knowledge of MedDRA dictionary
Excellent knowledge of drug development process
Experience reviewing cumulative safety data

Job Responsibility

Provide dynamic leadership, strategic direction and governance of patient safety and PV risk management activities
Lead signal detection and risk management activities for assigned products
Lead proactive and ongoing analysis and interpretation of non-clinical data, clinical, post-marketing, scientific literature
Lead PV during interactions with Regulatory Authorities (RA)
Perform individual case safety report (ICSR) medical review
Lead multidisciplinary Safety Management Committee (SMC) and Executive Safety Committee (ESC)
Serve as PV SME in support of regulatory filing activities
Collaborate with cross functional team
Address internal/external safety-related requests
Provide guidance regarding Statistical Analysis Plans

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, Clinical Development

We are seeking an experienced, highly motivated Medical Director, Clinical Devel...

Location

United States , Waltham; San Diego

Salary:

205000.00 - 250000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

2+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
Hands-on experience designing and executing clinical trials
Experience with IND submissions and global regulatory filings
Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
Excellent written and verbal communication skills, including protocol and regulatory document writing
Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
Can work independently
self-starter attitude
MD or equivalent is required

Job Responsibility

Responsible for medical monitoring/reporting and safety activities
Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
Acts as the medical contact at the company for clinical/medical issues
Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
Serve as the medical expert for assigned assets studies
Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
Oversee and support data interpretation, analysis, and clinical study reports
Work closely with internal stakeholders, including Regulatory, Safety, CMC, and Translational Science teams
Partner with external collaborators, KOLs, CROs, and investigators

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Senior Medical Director, Clinical Development

Cabaletta is seeking an experienced, highly motivated hands-on physician leader ...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

D., M.D./Ph.D. degree or equivalent required
Board Certification, Board Eligibility, or clinical experience in the field of Rheumatology and/or Immunology highly desirable
7+ years of experience in clinical research, including the design and execution of complex clinical trials, with a pharmaceutical or biotech company
Experience with or exposure to the development of adoptive cell therapies or biologic therapies is desirable
Experience with Health Authority interactions and submission of clinical regulatory documents is desirable
Strong written and verbal communication skills
ability to easily engage with investigators and key external experts
and ability to effectively present at conferences, advisory meetings, and other public for a
Engaged, hands-on, independent, and goal-oriented mentality
willingness to work in highly dynamic work environment

Job Responsibility

Provide medical leadership for various programs from first-in-human studies through registrational studies
Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities
Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities
Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings
Actively contribute during Health Authority interactions
Review available preclinical data that could inform the design of future clinical trials
Present at site evaluation and site initiation visits as applicable
In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data

What we offer

health and retirement, PTO, and stock option plans

Medical Director, Clinical Development - Dermatology/Immunology

We are seeking a Medical Director to oversee clinical execution and medical moni...

Location

United States

Salary:

280000.00 - 325000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MD is required
Experience in clinical development within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
2+ years’ industry experience as a medical monitor and/or medical director
Experience working on phase 2 and 3 clinical studies required
Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others
Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability to travel approximately 20% to All Team meetings, functional meetings, study-related activities, and medical conferences

Job Responsibility

Serve as a medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the Medical Monitoring Plan
Support the design of trials and develop protocols and other relevant documents for individual studies
Support all the start-up activities related to the assigned dermatology clinical study
Oversee day-to-day clinical and medical execution of studies
Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
Partner with clinical operations on site selection, recruitment, and CRO management
Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Associate Medical Director, Pediatrics

Provide medical leadership in pediatrics and collaborative clinical support to a...

Location

United States

Salary:

180000.00 - 200000.00 USD / Year

Pomelo Care

Expiration Date

Until further notice

Requirements

Medical degree from an accredited US medical school
Successful completion of an accredited US residency program in a directly related field (Pediatrics or Family Medicine with substantial experience with pediatrics)
A minimum of three years of post-residency experience in pediatric primary care and/or pediatric urgent care
Active, unrestricted license to practice in any US state and willingness to obtain licenses in all US states via the Interstate Medical Licensure Compact
Experience leading successful teams, with track record of outstanding collaboration and teamwork
A sense of urgency to improve clinical outcomes coupled with exceptional organization and attention to detail
A growth mindset with the ability to approach process change and ambiguous situations with enthusiasm, creativity, and accountability
Facility using multiple tech platforms, with an eagerness for advising about platform improvements and adapting to new systems
Eager to thrive in a fast-paced, metric-driven environment
Phenomenal interpersonal and communication skills

Job Responsibility

Provide collaborative physician supervision and consultation for an experienced team of APPs, nursing leadership, and RNs in the field of pediatrics including conducting quality assurance review for Pediatric APPs
Serve as the pediatric medical director in regional cross-disciplinary team-based care coordination meetings and work with in-house clinical specialties to develop holistic individualized care plans
Own clinical content development for our Pediatrics program, serving as the subject matter expert across internal clinician-facing protocols and patient-facing content
Support the recruitment and training of pediatric medical providers
Help drive our population health programs toward healthier outcomes by partnering closely with Market Operations leads and OB Regional Medical Director to identify gaps and improvement opportunities
Identify and implement interventions to address cross-disciplinary or practice performance improvement needs
Facilitate and lead cross-disciplinary review sessions for episodic events and pediatric case reviews
Engage directly in patient care as a Pomelo provider
Actively participate in on-call schedules including overnights, weekends, and holidays

What we offer

Competitive healthcare benefits
Generous equity compensation
Generous PTO policy

Fulltime

Medical Director-Health Care Delivery, Clinical Perf-At Home

At CVS Health, we’re building a world of health around every consumer and surrou...

Location

United States , Illinois

Salary:

174070.00 - 374920.00 USD / Year

CVS Health

Expiration Date

July 01, 2026

Requirements

M.D. / D.O. in good standing with no restrictions required
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
5+ years of experience in outpatient practice preferred
Providers who have been at OSH for a minimum of 1 year are welcome to apply
Fellowship training in Geriatrics and/or other professional degrees (e.g., M.B.A., J.D., M.P.H.) welcome but not required
Working knowledge of adult learning and prior experience of developing lectures and presentations for remote and in-person learners
Willingness to shadow and conduct patient visits, as needed, to test workflows and clinical skills in direct patient care settings
Minimum of 1 year in roles coaching providers and their teams to provide exemplary care

Job Responsibility

Onboarding
Content Development
Clinical development

What we offer

Mission-focused career impacting change and measurably improving health outcomes for Medicare patients
Paid vacation, sick time, and investment/retirement 401K match options
Health insurance, vision, and dental benefits
Opportunities for leadership development and continuing education stipends
New centers and flexible work environments
Opportunities for high levels of responsibility and rapid advancement

Fulltime

Medical Director, Clinical Development

Kailera Therapeutics

Location:
United States , Waltham

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 10, 2026

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Job Posted:January 10, 2026

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