New · posted Nov 1
PTC Therapeutics · Biotechnology
Senior Director, Clinical Development
- Warren, NJ +1 more
- Hybrid
- Full-time
- Director
The role
The Senior Director, Clinical Development provides strategic input for the clinical/medical aspects of all phases of the drug development process and will work closely with the leader of research and development team to achieve the clinical development goals for these compounds.
The incumbent is accountable for ensuring that Clinical Development Plans (CDPs), clinical trials and protocols are properly designed and that they are executed in accordance with applicable Good Clinical Practice (GCP) regulations. The incumbent has medical responsibilities for assigned clinical studies and leads the analyses 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. He/she oversees the activities of multiple functions aligned with clinical development projects within the Clinical Development organization, including but not limited to: clinical operations, drug safety, and biostatistics. He/she also has the primary responsibility for establishing and maintaining external relationships and alliances with Key Opinion Leaders (KOLs) and academic consortia.
The Senior Director, Clinical Development is a key representative of PTC's clinical development organization in meetings with external stakeholders and audiences as needed; as such he/she may author or review, for quality purposes, 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 Senior 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 5 years of clinical drug development experience in a pharmaceutical, biotechnology or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
Demonstrated hands-on experience leading a large, multi-country, clinical development program.
Demonstrated working knowledge of early- and late-phase drug development and applicable regulatory processes.
Demonstrated ability to lead/oversee clinical trial design, conduct and interpretation of clinical data.
Hands-on experience with the development of 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 or clinical specialty
Experience working in rare/orphan disease clinical development.
Previous supervisory experience.
* Travel requirements
Up to 30 %
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
Leads, contributes to and directs PTC’s global clinical development strategy for his/her assigned indication and/or therapeutic area.
Leads/Facilitates the design of CDPs and ensures they enable PTC to: 1) demonstrate clinical/medical benefit(s) and 2) achieve compound and commercial development objectives; provides clinical input to non-clinical and commercial functions on matters related to these objectives.
Manages relationships with external partners (e.g. Clinical Research Organizations (CROs) and other vendors, consultants, collaborators, etc.); monitors program/study budgets to ensure the timely and cost-effective implementation of CDP(s); reviews and approves contracts, work orders and invoices within grant of authority; participates in the assessment of CROs, vendors, consultants or other partners as necessary.
Medically responsible for clinical studies.
Facilitates communication and collaboration with internal, cross-functional team members including, but not limited to, research, manufacturing, drug supply, regulatory, quality assurance, marketing and external key stakeholders including, but not limited to, collaborators, KOLs, investigators and domestic and international regulatory authorities, to support CDPs, regulatory submissions and clinical development goals.
Ensures adherence to the highest scientific, ethical and regulatory standards and ensures compliance with all applicable GCP regulatory requirements
Represents PTC's Clinical Development team in meetings with external collaborators regarding the status of partnered clinical development projects
Supports the assessment of in-licensing product candidates in area of expertise, as needed.
May manage, coach and mentor direct reports.
Performs other tasks and assignments as needed and specified by management.
Pay and benefits
$289,200 – $364,000 a year
Employer providedExpected Base Salary Range: $289,200 - $364,000. 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 plan
Dental plan
Vision plan
Retirement savings plan
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 9% above 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 | $289,200 | — | $364,000 |
| 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 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Clinical trial conduct12
- Lab testing and methods4
- Documentation and SOPs3
- GMP and compliance2
- Regulatory submissions2
- Investigations and CAPA1
- 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%
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Senior Director, Clinical Development at PTC Therapeutics
Open until filled. $289K–$364K a year, employer provided.