Director, Early Clinical Development at PTC Therapeutics, Inc. in SOUTH PLAINFIELD, New Jersey

Job Description:

Job Description Summary:

The Director, Early Clinical Development contributes to the development and execution of early clinical development strategy across project teams to develop and implement natural history plans for all early drug programs, proof of concept studies (PoC) and First in Human (FIH) investigational trials. The incumbent also implements streamlined approaches to PK/PD and ADME characterization..

The incumbent works cross-functionally within and across project teams and contributes to PTC’s global early clinical development strategy for one or more therapeutic areas, compounds and/or indications; ensures the design and execution of appropriate Clinical Development Plans (CDPs) to generate FIH, PK, PD, PK/PD, or efficacy/PoC and natural history data that enables PTC to: 1) to support continued clinical development or no-go decisions for the programs and 2) achieve compound and commercial development objectives. The incumbent may provide clinical/medical/scientific input to non-clinical and commercial functions on matters related to these objectives.

The Director, Early Clinical Development also manages/oversees strategic alliances with external pharmaceutical/biotechnology partners and/or philanthropic/academic institutions as directed by the Manager. These responsibilities include facilitating the relationships with external partners and providing support and technical expertise to various internal functions as appropriate.

The incumbent works cross-functionally with internal departments and external resources on Early Clinical Development related issues.

The Director, Early Clinical Development ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

• Supports early clinical development projects by serving on project teams.


• Partners with internal and external collaborators to establish natural history analysis plans to ensure delivery of high-quality data to support analysis, interpretation, and design of clinical studies.


• Participates in team presentations to internal and external stakeholders, including health authorities.


• Manages relationships with external partners (e.g. Clinical Research Organizations (CROs) and other vendors, consultants, collaborators, etc.) to validate and implement natural history datasets in support of PTC development programs; participates in the assessment of clinical research organizations (CROs), vendors, consultants or other partners as necessary.


• Manages/oversees strategic alliances with external pharmaceutical/biotechnology partners, investigators, patient advocacy groups and academic institutions; liaises with patient advocacy groups and academic institutions for pre-clinical research requests.  Assists and coordinates with Legal and CMC groups to establish LOIs, CDAs and MTAs to support transfer of research compounds.  


• Coordinates with pre-clinical science to understand how the results of pre-clinical experiments can be used to inform clinical trials. Participates in development and review of clinical documents such as protocols, transfer of historical knowledge, prioritizing pre-clinical work and resource needs.


• Facilitates communication and collaboration with internal, cross-functional team members (e.g. research, manufacturing, drug supply, regulatory, quality assurance, project management, marketing, etc.) and external key stakeholders (e.g. collaborators, Key Opinion Leaders (KOLs), investigators, domestic and international regulatory authorities, etc.) to support CDPs,  to ensure early definition of, and agreement on natural history and clinical pharmacology strategy for clinical development and regulatory approvals and corporate goals.


• Facilitates/maintains relationships with external preclinical/clinical investigators and KOLs on study-related issues both on-going and potential, as appropriate.  Assists in the preparation of consulting agreements and other contracts, speaker honorariums, and guest visits.


• Represents PTC's Early 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.


• Attends and participates in scientific conferences, reviews and edits scientific/clinical documents (including publications) and participates in investor calls and meetings with analysts.  


• Performs other tasks and assignments as needed and specified by management. 

Qualifications:

* Minimum level of education and years of relevant work experience.

• MD (or PhD in a scientific discipline) and a minimum of 5 years of clinical development or pharmaceutical research and development (R&D) experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment. 

* Special knowledge or skills needed and/or licenses or certificates required.

• In-depth understanding of the drug developmental process including hands-on experience influencing project teams (in a matrixed environment).


• Ability to work effectively with internal and external stakeholders, strong people skills to work effectively in a team environment and ensure maximum alignment and shared common goals.


• Experience with early clinical development and Investigational New Drug applications (INDs) preparations/submissions.


• Experience in the design of natural history studies and analysis of natural history datasets, and their incorporation in clinical trial design(s).


• Working knowledge of clinical trial design, conduct, data acquisition and reporting.


• Experience supporting or managing multi-partner alliances.


• Ability to influence without direct authority. 


• Proficiency with Microsoft Office.


• Excellent verbal and written communication and skills including presentation 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.

• Experience working in rare/orphan disease research with a strong background in ocular diseases.

* Travel requirements: 10 – 15 %

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

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.

Click here to return to the careers page

Apply Now