New · posted Nov 10
Pfizer · Pharmaceuticals
Associate Director, Clinical Development Medical Director (MD Required)
- Collegeville, PA
- Hybrid
- Full-time
- Director
The role
The Associate Director, Clinical Development Medical Director:
- Is accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high-quality clinical trials, employing quantitative design principles, and clinical best practices to deliver both clinical and operational excellence.
- Is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. The Associate Director, Clinical Development Medical Director is accountable for timely delivery of a quality protocol, clinical execution of clinical trials and supports appropriate interpretation and communication of clinical trial data.
- Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues through timely, diligent clinical data, safety and protocol deviation review. May perform medical monitoring of one of more clinical trials.
- Will be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
What you need
BASIC QUALIFICATIONS
- As medically qualified individual, the successful candidate must have the following qualifications:
- Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has Clinical Research experience
- Been licensed by a licensing body/health authority to prescribe medicines independent of Supervision for at least 2 years post their intern/house officer/foundation period.
- Clinical research experience in phase 3/pivotal space
- Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Global travel may be required
Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
The annual base salary for this position ranges from $189,200.00 to $315,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Preferred Qualificationsnice to have
- Have maintained registration/Medical License to practice and always have been in good standing with their Medical Licensing Authority preferred.
- Clinical Research experience in industry/CRO.
- Cardiometabolic disease experience highly preferred (ie, cardiology, obesity, endocrinology, nephrology etc.)
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- Demonstrated clinical/medical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English, in relating to individuals both inside and outside Pfizer
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
- Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Skills named in this posting
What you'll do
- Performs medical monitoring on one or more clinical trials: Provides study-related medical information and assistance, e.g., on:
- medical questions from investigators, site personnel and non-study health care providers
- safety findings, medical issues, and complex serious adverse events
- audits or inspection medical responses
- Contributes to final significant quality event medical assessments.
- Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.
- Reviews required safety text and endorses significant medical changes in the Informed Consent Document.
- Provides clinical/medical input to support development of the protocol design document (PDD).
- Leads or supports development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/supports the Global Development Lead in governance review and approval process.
- Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
- Provides clinical/medical input to the development of data collection tools. Responsible for providing clinical/medical input to SAP, TLFs and BDR.
- Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
- Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
- Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
- Inputs to, reviews, and approves, Risk Management and Safety Review Plan. .Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc) to develop and implement any risk mitigations.
- Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
- Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol.
- Reviews, reports and manages protocol deviations.
- Reviews patient level and cumulative data per the data review plan across one or more studies.
- Reviews safety data, SAE reports, TME’s, DME’s and ensures clinical documents (eg ICD) are updated as required. Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
- May act as the medical monitor for one or more clinical trials.
- Ensures TMF compliance for clinical documents.
- Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.
- Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection
- May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses) if required.
- May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs)
- Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
Pay and benefits
$189,200 – $315,400 a year
Employer provided401(k) with Pfizer matching contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Medical, prescription drug, dental and vision coverage
Annual bonus and long-term incentive eligibility
Where you'll work
Collegeville, PAHybridOpen in Maps (opens in a new tab)
More jobs in Collegeville, PAEqual opportunity, accessibility and legal noticesPfizer's statements, word for word
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 16% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in Pennsylvania13 roles publishing pay
Director roles in the US220 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $189,200 | — | $315,400 |
| Pennsylvania (middle half) | $252,000 | $297,000 | $323,000 |
| All US (middle half) | $255,000 | $300,000 | $335,500 |
This role: Pfizer's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 289 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Pfizer's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 49 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct25
- Documentation and SOPs14
- Collaboration and leadership13
- GMP and compliance8
- Investigations and CAPA7
- Quality systems and risk3
- Regulatory submissions2
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in pharmaceuticals, led by the four this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- CMSOpen Payments (Sunshine Act)(official source, opens in a new tab)Reporting of manufacturer payments to physicians and teaching hospitalsNamed in the posting
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
Company hiring pulse
Pfizer on Regulatory Jobs
- 20
- Open roles
- 20
- Distinct roles
- 10
- Locations
By discipline
- Clinical11 55%
- Quality9 45%
By level
- Director9 45%
- Manager4 20%
- Senior & Principal4 20%
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Associate Director, Clinical Development Medical Director (MD Required) at Pfizer
Applications close November 20. $189K–$315K a year, employer provided.