137 Clinical Development Director jobs in Glenolden

Berlin, Germany; London, United Kingdom; Mainz, Germany | full time | Job ID: 6963

The Senior Director Clinical Development will collaborate closely with the VP of Clinical Development to lead clinical strategies for assigned programs. This role involves overseeing the design and execution of clinical trials from early to late stages, ensuring data integrity, patient safety, and regulatory approval. You will lead a matrix team and apply your deep understanding of scientific, medical, and disease biology to guide decisions.

Key Responsibilities:

• Oversee and steer clinical trial design and execution, developing clinical plans for new compounds and leading towards regulatory approval.
• Collaborate with the VP to operationalize clinical strategies for assigned portfolios.
• Lead program strategy, development plans, and submission processes.
• Serve as Program Lead, guiding core teams and aligning objectives across functions.
• Ensure medical and safety aspects of studies, including risk-benefit assessments and medical queries.
• Work closely with Clinical Operations to ensure patient-centric drug development.
• Drive innovation in trial design, leveraging digital endpoints and real-world evidence.
• Prepare key clinical documents (e.g., Investigator's Brochures, NDAs) and ensure high-quality medical content in Clinical Study Reports.
• Manage relationships with external stakeholders and represent the team in governance meetings.

• M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology
• Several years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and NDA submission.
• Thorough understanding of the clinical and scientific methods and approaches used in clinical development studies, as
• novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities.
• Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage.
• Strong medical experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects.
• Ability to apply situational management style to both mentor and accelerate capabilities of its reports

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

Executive Medical Director, Clinical Development

About the Company

Innovative biopharmaceutical company

Industry
Pharmaceuticals

Type
Public Company

Founded
1994

Employees
51-200

Categories

• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• Biotechnology

About the Role

The Company is in search of a Vice President / Executive Medical Director to spearhead the clinical development of its neuromuscular asset. The successful candidate will be the primary clinical development leader, engaging in both internal and external interactions with key stakeholders. This role demands a deep understanding of the science behind the pipeline, excellent leadership skills, and a commitment to the development of new treatments for patients. Responsibilities include serving as the lead physician in all clinical development activities, collaborating with cross-functional teams to create and revise clinical development plans, and leading the design of clinical protocols. The role also involves overseeing the medical monitor, ensuring the continuous evaluation of the drug's safety profile, and participating in interactions with global health authorities. Applicants must have an MD or DO, with board certification/eligibility in neuromuscular and/or rare disease highly desired. A minimum of 7 years of experience in the pharmaceutical or biotech industry, including leading late-stage clinical trials, is required. The ideal candidate will have a proven track record in global clinical research, interaction with health authorities, and successful experience in the end-of-phase 2 and/or NDA/BLA processes. The role calls for an individual with a strong background in clinical trial design, methodology, and statistical concepts, as well as a history of success in leading cross-functional product teams. Outstanding leadership, problem-solving, organizational, and communication skills are essential, as is the ability to travel and work in a highly collaborative, multidisciplinary team setting.

Hiring Manager Title
CMO

Travel Percent
20%

Functions

• Medical Care/Hospital Administration
• Non-Profit Management

Executive Medical Director, Clinical Development

About the Company

Innovative biopharmaceutical company

Industry
Pharmaceuticals

Type
Public Company

Founded
1994

Employees
51-200

Categories

• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• Biotechnology

About the Role

The Company is in search of a Vice President / Executive Medical Director to spearhead the clinical development of its neuromuscular asset. The successful candidate will be the primary clinical development leader, engaging in both internal and external interactions with key stakeholders. This role demands a deep understanding of the science behind the pipeline, excellent leadership skills, and a commitment to the development of new treatments for patients. Responsibilities include serving as the lead physician in all clinical development activities, collaborating with cross-functional teams to create and revise clinical development plans, and leading the design of clinical protocols. The role also involves overseeing the medical monitor, ensuring the continuous evaluation of the drug's safety profile, and participating in interactions with global health authorities.

Applicants must have an MD or DO, with board certification/eligibility in neuromuscular and/or rare disease highly desired. A minimum of 7 years of experience in the pharmaceutical or biotech industry, including leading late-stage clinical trials, is required. The ideal candidate will have a proven track record in global clinical research, interaction with health authorities, and successful experience in the end-of-phase 2 and/or NDA/BLA processes. The role calls for an individual with a strong background in clinical trial design, methodology, and statistical concepts, as well as a history of success in leading cross-functional product teams. Outstanding leadership, problem-solving, organizational, and communication skills are essential, as is the ability to travel and work in a highly collaborative, multidisciplinary team setting.

Hiring Manager Title
CMO

Travel Percent
20%

Functions

• Medical Care/Hospital Administration
• Non-Profit Management

Reference #: 354322 Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence. Posted Date: Nov 29 2022 Associate Director, Clinical Development (Physician) If you're looking to collaborate with world-class physicians and scien Director, Development, Clinical, Clinical Research, Physician, Associate, Technology, Healthcare

Senior Executive Medical Director, Clinical Development

About the Company

Join an innovative biopharmaceutical company dedicated to transforming the future of medicine.

Industry
Pharmaceuticals

Type
Public Company

Founded
1994

Employees
51-200

Categories

• Manufacturing
• Pharmaceuticals
• Medicine
• Chemical Products
• Biotechnology

About the Role

We are seeking a dynamic and experienced Senior Executive Medical Director to lead the clinical development of our cutting-edge neuromuscular asset. This pivotal role will have you at the forefront of clinical innovation, engaging with both internal teams and external stakeholders to drive our mission of delivering new treatments to patients. As the primary clinical development leader, you will oversee all clinical development activities, ensuring alignment with our strategic vision.

Your responsibilities will include:

• Serving as the lead physician and driving all aspects of clinical development.
• Collaborating closely with cross-functional teams to create, implement, and revise comprehensive clinical development plans.
• Leading the design of innovative clinical protocols.
• Overseeing the medical monitor to maintain a continuous evaluation of the drug's safety profile.
• Engaging with global health authorities to advocate for our clinical programs.

To be successful in this role, you should possess an MD or DO, alongside board certification or eligibility in neuromuscular conditions or rare diseases. A minimum of 7 years of relevant experience within the pharmaceutical or biotech industry is essential, particularly in leading late-stage clinical trials. You will have a track record of excellence in global clinical research, successful interactions with health authorities, and experience navigating the end-of-phase 2 and/or NDA/BLA processes.

The ideal candidate will demonstrate robust clinical trial design expertise, a clear understanding of methodology, and statistical concepts, with a history of effectively leading cross-functional teams. Exceptional leadership, problem-solving, organizational, and communication skills are crucial, as well as the willingness to travel and work in a collaborative, multidisciplinary environment.

Hiring Manager Title
CMO

Travel Percent
20%

Functions

• Medical Care/Hospital Administration
• Non-Profit Management

SUMMARY/JOB PURPOSE:

In collaboration with the Exelixis clinical teams, the primary role is to lead and execute early/late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion.

Essential Duties And Responsibilities:

* Support the establishment of clinical trial strategies for oncology products in development.
* Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
* Act as medical monitor for company sponsored trials.
* Support project teams with therapeutic area specific information.
* Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
* Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
* Interact with key opinion leaders and investigators in relevant disease specific area.
* Ensure consistency of scientific and development strategies for oncology products in development.
* Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.

Supervisory Responsibilities:

* Supervise employees, both directly and indirectly via subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

* MD with board certification or eligibility in Oncology or Hematology/Oncology and 10 years post-residency related experience; or,
* Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

* Nine years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered.
* Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.
* Participated in clinical oncology studies with molecular targeted or immunological therapies.
* Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).

Knowledge/Skills:

* Proven ability to effectively work in a cross-functional/matrix environment
* Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
* Develops technical and/or business solutions to complex problems.
* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
* Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
* Ability to develop and maintain relationships with significant key opinion leaders.
* Strong interpersonal, influencing, presentation, and written and verbal communication skills
* Strong organizational and time management skills

JOB COMPLEXITY:

* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
* Works on abstract problems across functional areas of the business
* Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
* May ensures budgets and schedules meet corporate requirements.
* Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.

#LI-JD1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to Medical Director, Development, Clinical, Oncology, Director, Clinical Research, Healthcare

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.

This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham. MA or Boston. MA); or Poland (Warsaw).

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

• Medical degree with completion of post medical education clinical residency training
• Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
• 3+ years of oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
• Documented academic and/or clinical research publication history or history of medical practice in the fields noted above.
• Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

• Board/registration certified or eligible physician with a PhD degree
• Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution

The Medical Director, Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts.

This role requires a physician capable of developing and executing oncology clinical trials in support of the successful clinical development, regulatory filing and initial market launch of a growing portfolio of innovative and transformational Oncology agents.

Please note: This position requires an on-site office -based presence 2 to 3 days a week in the UK (London or Stevenage); Switzerland (Zug); US (Upper Providence, PA. Waltham. MA or Boston. MA); or Poland (Warsaw).

• Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others in a complex matrix environment to develop and execute phase 1-3 interventional clinical trials
• Ensure high quality protocol development aligned with the Clinical Development Plan to effectively determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.
• Use medical expertise to contribute to the end to end (protocol concept to final study report) to ensure scientific integrity and timely delivery of clinical trials which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into decision making
• Interpret and summarize study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.
• Assume medical responsibility for clinical trials with active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions, and addressing urgent safety questions (with inclusion of Safety/ PV as relevant).
• Assume responsibility for medical review of clinical trial data, both directly as needed and/or via oversight of delegated medical review. Oversee blinded review of data packages intended for IDMCs.
• Review/monitor safety data in collaboration with pharmacovigilance group for active clinical studies.
• Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
• Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data.
• Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision.
• Understand biological mechanisms, clinical strategy, scientific interpretation of disease and target-based literature.
• Serve as a core member of the Clinical Matrix Team for one or more assets in development.
• Represent Clinical Development on disease area strategy, integrated evidence and medical affairs strategy teams.
• Participate in Oncology Clinical Development-wide initiatives and workstreams as appropriate.

• Medical degree with completion of post medical education clinical residency training
• Board/registration qualifications in medical oncology, hematology, pathology or internal medicine
• 3+ years of oncology experience in pharmaceutical/biotechnology industry and clinical practice experience in the fields noted above
• Documented academic and/or clinical research publication history or history of medical practice in the fields noted above.
• Strong working knowledge of the clinical drug development process with experience in the conduct/participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
• Experience in regulatory requirements to support registration, including knowledge and adherence to GCP principles

• Board/registration certified or eligible physician with a PhD degree
• Experience in leading oncology clinical trials, including experience with study design, data review/interpretation and the overall clinical development process
• Robust knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution