Director, Clinical Development

ptcbio; New Jersey; On-site; USD 180,000 - 260,000; Full time

Job summary

PTC Therapeutics, a global biopharmaceutical company, seeks a Director, Clinical Development to guide the clinical drug development process across phases.

You will design and oversee Clinical Development Plans, lead trial design, support regulatory submissions, and collaborate cross-functionally with internal teams and external partners. Travel up to 25% may be required.

Qualifications

• MD degree with minimum two years of clinical drug development experience.
• Experience managing one or more global clinical programs.
• Knowledge of regulatory submissions and drug development milestones.
• Excellent verbal and written communication in a fast-paced, matrixed environment.

Responsibilities

• Contributes to study protocol design, amendments and CSRs.
• Approves sites and facilitates investigator meetings.
• Prepares study update reports with enrollment and safety data.
• Interprets and documents clinical data for regulatory and publications.
• Manages study timelines and external vendor relationships.
• Represents the study team in cross-functional meetings.
• Ensures regulatory compliance with SOPs and guidelines.
• Provides clinical input to non-clinical and commercial teams.

Skills

Clinical development

Regulatory submissions

Cross-functional collaboration

Excellent communication

Problem solving

Travel flexibility

Education

MD degree

Tools

Microsoft Office

Job description

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

Job Description Summary

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.

Job Description

ESSENTIAL FUNCTIONS

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.

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 %
• Expected Base Salary Range: $2