New · posted Nov 1
PTC Therapeutics · Biotechnology
Director, Clinical Development
- Warren, NJ +1 more
- Hybrid
- Full-time
- Director
The role
The Director, Clinical Development provides tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.
The incumbent is involved in the design, development and execution of Clinical Development Plans (CDPs), clinical trials and protocols in accordance with applicable Good Clinical Practice (GCP) regulations. The incumbent leads and contributes to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical, regulatory and commercial objectives and the documentation of study results.
As needed, he/she may be assigned as the primary clinical/medical representative in meetings with external stakeholders, partners or other external audiences as needed. This includes, but may not be limited to, Key Opinion Leaders (KOLs), investigators, regulatory authorities, partners, vendors, consultants, etc. As such he/she may author or review clinical/medical-related materials intended for external audiences.
The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues.
The Director, Clinical Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
.
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
What you need
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
MD degree and a minimum of 2 years of clinical drug development experience within a pharmaceutical, biotechnology or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
Demonstrated experience managing one or more global, clinical programs.
Knowledge of the pharmaceutical/biotechnology industry, including global drug development and regulatory processes, with particular knowledge of R&D, key clinical milestones, and the factors influencing critical development and decision-making points.
Demonstrated expertise in clinical trial design, conduct and interpretation of clinical data.
Previous experience with regulatory submissions.
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Ability to travel domestically and internationally.
*Special knowledge or skills and/or licenses or certificates preferred.
Board certification or equivalent in a medical/clinical specialty
Experience working in rare/orphan disease clinical development.
* Travel requirements
Up to 25 %
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
What you'll do
Primary duties/responsibilities
Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials.
Approves investigator sites for inclusion in study/studies. Plans and facilitates investigator meetings and presents selected sections of the agenda/content.
Prepares weekly and/or monthly study update reports which contain detailed information on enrollment data and adverse events as well as other general information relating to the progress of the study.
Interprets, summarizes and documents clinical data for CSRs, regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.) manuscripts, promotional material and other publications as required.
Approves and monitors clinical study timelines.
Contributes to vendor selection process and manages PTC’s relationship with certain external vendors, partners and investigators.
May represent the clinical study team at cross-functional, integrated team meetings.
Ensures adherence to appropriate regulations and SOPs.
Participates in the clinical review and recommendation of new opportunities such as target selections or clinical due diligence.
Provides clinical/medical input to non-clinical and commercial functions.
Performs other tasks and assignments as needed and specified by management.
Pay and benefits
$266,900 – $336,000 a year
Employer providedExpected Base Salary Range: $266,900 - $336,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
Short- and long-term incentives
Medical insurance
Dental insurance
Vision insurance
Retirement savings plans
Where you'll work
Warren, NJ +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Remote (US)
More jobs in Warren, NJ +1 moreEqual opportunity, accessibility and legal noticesPTC Therapeutics's statements, word for word
EEO Statement
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Job intelligence
The context around this role
Live data · November 3, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in New Jersey28 roles publishing pay
Director roles in the US212 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $266,900 | — | $336,000 |
| New Jersey (middle half) | $270,500 | $300,750 | $329,500 |
| All US (middle half) | $260,000 | $300,000 | $335,500 |
This role: PTC Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 3, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 272 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not PTC Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 38 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct14
- Collaboration and leadership9
- Documentation and SOPs6
- Investigations and CAPA4
- GMP and compliance2
- Lab testing and methods1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
PTC Therapeutics on Regulatory Jobs
- 13
- Open roles
- 12
- Distinct roles
- 4
- Locations
By discipline
- Clinical10 77%
- Regulatory2 15%
- Quality1 8%
By level
- Director6 46%
- Manager5 38%
- Senior & Principal1 8%
More roles at PTC Therapeutics
- View role
Senior Director, Clinical Development
Warren, NJ +1 more · HybridDirectorBiotechnology$289K–$364K
- View role
Senior Manager, Clinical Operations
Remote, USManagerBiotechnology$137K–$172K
- View role
Associate Director, Clinical Operations
Warren, NJ +1 more · HybridDirectorBiotechnology$170K–$214K
- View role
Associate Director, Clinical Data Management
Warren, NJ · HybridDirectorBiotechnology$164K–$206K
Similar Clinical Development roles elsewhere
- View role
Senior Director, Clinical Development (MD)
Gilead SciencesFoster City, CADirectorBiotechnology$275K–$391K
- View role
Senior Director, Clinical Development - Prostate Cancer
Bristol Myers SquibbRemote, USDirectorBiotechnology$307K–$372K
- View role
Medical Director, Clinical Trial Physician - Neurology
Thermo Fisher ScientificRemote, USDirectorBiotechnologySalary not listed
- View role
Medical Director/Clinical Trial Physician (Rheumatology) - FSP
Thermo Fisher ScientificRemote, US) - North CarolinaDirectorBiotechnologySalary not listed
Director, Clinical Development at PTC Therapeutics
Open until filled. $267K–$336K a year, employer provided.