Senior Director, Clinical Development (Early Development) USA -
New Jersey - South Plainfield
Job Description Summary: The Senior Director, Early Clinical
Development provides strategic input in developing and implementing
biomarker programs across different PTC Therapeutics sponsored
projects, proof of concept studies and first in human
investigational trials. The incumbent will work closely with the
Research, Clinical Development and Clinical Operations groups to
direct the translation of preclinical research into clinical
applications, to develop, validate and implement biomarkers and
pharmacodynamic and mechanism assays. The incumbent will have the
skills associated with the development of and approvals in the
companion diagnostic space. This role embraces the principles of a
translational medicine mindset, with a focus on operational
excellence and deep scientific rigor. The ideal candidate will have
a passionate desire to help transform current treatment paradigms
while working in an innovative and fast-paced environment.
The incumbent, in collaboration with the Research groups,
contribute to and implements biomarker strategy for clinical
studies in programs with attention to pharmacokinetics,
pharmacodynamics, proof of mechanism and patient selection
(companion diagnostics).. The incumbent, in collaboration with
others in Clinical Development, is responsible for the biomarker
aspect of clinical protocol design and writing, as well as
authoring the biomarker sections of Investigator Brochures,
Clinical Study Protocols and Reports, program documents, regulatory
submissions and responses (INDs/CTAs) as well as co-authoring,
assisting and supporting the development of publications,
abstracts, and presentations
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
This newly developed role will be dedicated to our early stage
Neurology programs with a focus on rare diseases. The incumbent
will look to build bridges with research teams to deliver
non-clinical package necessary to support translation into clinical
programs. This role will deal with a diverse portfolio in neurology
and will require a strong ability to think outside of the box. This
is a non-supervisory role but will need to utilize the power of
influence in progressing in working with said cross functional
The incumbent works cross-functionally with internal departments
and external resources on Clinical Development related issues.
The Senior Director, Early Clinical Development ensures
adherence to relevant regulatory requirements and company Standard
Operating Procedures (SOPs) as appropriate. Job Description:
Contributes to PTC’s global clinical development strategy for
his/her assigned indication and/or Therapeutic Area and leads the
implementation of the clinical strategy.
Provides input into Research and Translation activities as well
as the identification of early indications.
Provides strategic input in the design and implementation of
preclinical POC and mechanism studies.
Provides strategic input in the development and monitoring of
the quality of pharmacokinetic, pharmacodynamic and patient
stratification biomarker assays to support the advancement of
preclinical programs into the clinic.
Provides strategic input in the design and implementation of
biomarker analysis in clinical trials, ensuring operational
execution by partnering with biomarker labs and data management
according to cGCP guidelines.
Works with a cross functional team (Clinical Leads, Medical
Monitors, nonclinical and discovery Research Scientists,
Regulatory, Biostatistics and Clinical Operations) to ensure early
definition of, and agreement on biomarker strategy for clinical
development and regulatory approvals.
Maintains up-to-date knowledge of scientific and clinical
published literature in the relevant area(s).Partner with
biostatisticians and biomarker laboratories to establish biomarker
analysis plans to ensure delivery of high-quality data to support
analysis, interpretation and reports of clinical biomarkers for
internal decision-making and Health Authority submissions.
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
Represents PTC's Clinical Development team in meetings with
external collaborators regarding the status of partnered clinical
Supports the assessment of in-licensing product candidates in
area of expertise, as needed.
May manage, coach and mentor direct reports.
Qualifications: Advanced degree, may include MD, Ph.D. or
PharmD., and a minimum of 5 years of progressively responsible and
related experience in a pharmaceutical, biotechnology or related
* Special knowledge or skills needed and/or licenses or
Experience working in rare/orphan disease clinical
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
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
Ability to travel domestically and internationally.
*Special knowledge or skills and/or licenses or certificates
CNS or metabolic development experience
Previous supervisory experience.
* Travel requirements
20 – 30 %
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
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PTC is biopharmaceutical company focused on the discovery and
development of orally-administered, proprietary small molecule
drugs that target post-transcriptional control processes. While
PTC’s discovery programs are directed at targets in multiple
therapeutic areas, PTC is focusing particularly on the development
and commercialization of treatments for orphan and ultra-orphan
disorders. Post-transcriptional control processes regulate the rate
and timing of protein production and are essential to proper
cellular function. PTC’s internally-discovered pipeline addresses
multiple therapeutic areas, including neuromuscular disorders,
oncology and infectious diseases. For more information on the
company, please visit our website www.ptcbio.com. ?